August 9, 2008Drug Shortage: Drug to be Discontinued; Revex (Nalmefene HCl Injection) Drug Shortage: Drug to be Discontinued; Revex (Nalmefene HCl Injection)
Baxter has discontinued Revex production. Erythropoiesis Stimulating Agents (ESAs) - Epoetin alfa (marketed as Procrit, Epogen), Darbepoetin alfa (marketed as Aranesp) FDA clarifies approved conditions for use of ESAs in patients with cancer and revises dosing directions for the products. June 2008 Monthly Safety Labeling Summary of safety-related revisions to the BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, and ADVERSE REACTIONS sections of the Prescribing Information, plus Patient Package Inserts and Medication Guides. August 2008 Patient Safety News Video news show for healthcare professionals, covering safety alerts, recalls, product approvals, and important tips on protecting patients. Erythropoiesis Stimulating Agents (ESAs) - Epoetin alfa (marketed as Procrit, Epogen), Darbepoetin alfa (marketed as Aranesp) UPDATE - Dear Healthcare Professional letter added. Lucky Green Trading, Inc. Recalls Thai Basil Because of Possible Health Risk (July 9) LUCKY GREEN TRADING, INC. of Garden Grove, CA is recalling Thai Basil , because it has the potential to be contaminated with Salmonella , an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Rize 2 The Occasion Capsules, Rose 4 Her Capsules UPDATE - Voluntary nationwide recall of all lot numbers. FDA lab analysis found the products contained a potentially harmful, undeclared ingredient, thiomethisosildenafil. Resolved Drug Shortage: Digoxin oral tablets See website for more information about this resolved shortage. Recalls and Safety Alerts: Possible Association between TNF Blockers and Cancer Recalls and Safety Alerts: Possible Association between TNF Blockers and Cancer
FDA has informed healthcare professionals that it is investigating a possible association between drugs that block tumor necrosis factor (TNF) and the development of lymphoma and other cancers in children and young adults. This is part of FDA's ... Viapro 375mg Capsules Product recalled because it was found to contain a potentially harmful analog of Sildenafil. Simvastatin Used With Amiodarone Risk of rhabdomyolysis when simvastatin is used with amiodarone, particularly with simvastatin doses greater than 20 mg daily. Abacavir (marketed as Ziagen) and Abacavir-containing Medications Association between HLA-B*5701 allele and hypersensitivity reactions identified and patient screening for the allele recommended before starting or restarting treatment. June 2008 Monthly Safety Labeling Summary of safety-related revisions to the BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, and ADVERSE REACTIONS sections of the Prescribing Information, plus Patient Package Inserts and Medication Guides. Resolved Drug Shortage: Digoxin oral tablets See website for more information about this resolved shortage. Recalls and Safety Alerts: Warning Added to Regranex Label A boxed warning alerting healthcare professionals to an increased risk of cancer death has been added to the labeling for Regranex (becaplermin), a topical medication used to treat certain diabetic foot and leg ulcers. Based on a review of an ea... Desmopressin Acetate (marketed as DDAVP Nasal Spray, DDAVP Rhinal Tube, DDAVP, DDVP, Minirin, and Stimate Nasal Spray) UPDATE - December 2007 Dear Healthcare Professional Letter and revised labeling (re: hyponatremia and seizures) added to previous alert. FDA: Some cholesterol and heart drugs don't mix - KCBY FDA: Some cholesterol and heart drugs don't mix - KCBY
WASHINGTON (AP) - Patients taking some common medications for high cholesterol and irregular heart beats can suffer severe muscle damage because of a problem in the way the drugs interact, the government warned on Friday. The Food and Drug Source: www.kcby.com Loophole in tobacco regulation bill would allow some new product sales - Newsday WASHINGTON (AP) _ A loophole in a sweeping tobacco regulation bill would give the industry a 21-month window to introduce some new products without first getting federal approval. The House last month overwhelmingly passed the legislation, which for Source: www.newsday.com FDA gives priority review to Sanofi's Multaq - Boston Globe PARIS— U.S. regulators have given priority review status to Sanofi-Aventis' Multaq treatment for irregular heartbeat, a ruling that could help speed the drug's launch, the French pharmaceutical company said Friday. Drugs given the Food and Drug Source: www.boston.com UPDATE:FDA Sends Alert On Muscle-Injury Risk Tied To 2 Drugs - CNN Money WASHINGTON -(Dow Jones)- Federal regulators continue to receive reports of muscle injury in patients taking a combination of simvastatin, which is used in the controversial cholesterol drug Vytorin, and the heart-rhythm medication amiodarone Source: money.cnn.com FDA OKs Flu Vaccines for 2008-09 Season - Atlanta Journal Constitution TUESDAY, Aug. 5 (HealthDay News) -- With the memory of last season's flu vaccine mismatch still fresh, U.S. health officials announced Tuesday that they have approved vaccines for the 2008-09 season that include new strains of the virus most likely Source: www.ajc.com FDA Extends Review Timeline for Ustekinumab Biologic License - Forbes HORSHAM, Pa., Aug. 8 /PRNewswire/ -- Centocor, Inc., today announced that the U.S. Food and Drug Administration (FDA) has extended the review timeline for the Biologic License Application for ustekinumab, a subcutaneous biologic therapy, by three Source: www.forbes.com Vanda shares dive 73% to 90¢ - Baltimore Sun Vanda shares dive 73% to 90¢ - Baltimore Sun
Shares of Vanda Pharmaceuticals fell 73 percent yesterday to its lowest level since going public two years ago after the Rockville company said the U.S. Food and Drug Administration rejected its schizophrenia drug, known as iloperidone. In a letter Source: www.baltimoresun.com UPDATE:FDA Sends Alert On Muscle-Injury Risk Tied To 2 Drugs - CNN Money WASHINGTON -(Dow Jones)- Federal regulators continue to receive reports of muscle injury in patients taking a combination of simvastatin, which is used in the controversial cholesterol drug Vytorin, and the heart-rhythm medication amiodarone Source: money.cnn.com FDA: Some cholesterol and heart drugs don't mix - KCBY WASHINGTON (AP) - Patients taking some common medications for high cholesterol and irregular heart beats can suffer severe muscle damage because of a problem in the way the drugs interact, the government warned on Friday. The Food and Drug Source: www.kcby.com Some cholesterol and heart drugs do no mix - CNBC WASHINGTON - Patients taking some common medications for high cholesterol and irregular heart beats can suffer severe muscle damage because of a problem in the way the drugs interact, the U.S. government warned on Friday. The Food and Drug Source: www.cnbc.com FDA Warns Consumers About Potential Problems at Two Baltimore Pharmacies FDA Warns Consumers About Potential Problems at Two Baltimore Pharmacies
The U.S. Food and Drug Administration is warning consumers who filled prescriptions at The Medicine Shoppe pharmacies located at 8035A Liberty Road and 5900 Reisterstown Road in Baltimore that they may have received drugs that were either expired or suspected counterfeit. The FDA is particularly concerned because a number of the drugs are for serious diseases and could have an adverse effect on treatment. FDA Extends Consumer Warning on Serrano Peppers from Mexico Laboratory testing by the U.S. Food and Drug Administration has confirmed that both a sample of serrano pepper and a sample of irrigation water collected by agency investigators on a farm in the state of Nuevo Leon, Mexico, contain Salmonella Saintpaul with the same genetic fingerprint as the strain of bacteria that is causing the current outbreak in the United States. Stronger Warnings Requested for Fluoroquinolones FDA has notified manufacturers of fluoroquinolones that a boxed warning on the increased risk of tendinitis and tendon rupture is necessary. Jack Distribution, LLC. Issues a Voluntary Nationwide Recall of Select Lots of Rize 2 The Occasion Capsules and Rose 4 Her Capsules (July 1) Jack Distribution, LLC, and its wholesale distributors G and N Works, Inc., and Devine Distribution, Inc., announced today that they are conducting a voluntary nationwide recall of the following lot numbers of the company's supplement products sold under the brand names Rize 2 The Occasion and Rose 4 Her. (Rize 2 lot numbers CG-84 expires 11/10, GD-98 expires 08/10, CC-06 expires 06/10, 709 expires 09/10, CG-79 expires 11/10) (Rose 4 Her lot number CG-78 expires 11/10). FDA Advises Against Consumption of American Lobster (Maine Lobster) Tomalley The U.S. Food and Drug Administration today warned consumers to avoid eating tomalley in American Lobster (Maine Lobster), regardless of where the lobster was harvested, because of potential contamination with dangerous levels of the toxins that cause Paralytic Shellfish Poisoning (PSP). Lucky Green Trading, Inc. Recalls Thai Basil Because of Possible Health Risk (July 9) LUCKY GREEN TRADING, INC. of Garden Grove, CA is recalling Thai Basil , because it has the potential to be contaminated with Salmonella , an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Beware of Bug Bites and Stings Ticks, mosquitoes, and bees--here are tips for preventing and treating bug bites and stings. Are You Storing Food Safely? When, where, and how you store food can help prevent foodborne illnesses. Here are pointers for safely storing food in your refrigerator, freezer, and cupboards. Medicsight Receives Brazilian State Food and Drug Administration - Forbes Medicsight Receives Brazilian State Food and Drug Administration - Forbes
NEW YORK, Aug. 7 /PRNewswire-FirstCall/ -- Medicsight PLC, a subsidiary of MGT Capital Investments, Inc. (Amex: MGT), and an industry leader in the development of Computer-Aided Detection (CAD) and image analysis software, today announced that it has Source: www.forbes.com 2nd UPDATE: FDA Alerts On Muscle-Injury Risk Tied To 2 Drugs - CNN Money WASHINGTON -(Dow Jones)- Federal regulators continue to receive reports of muscle injury in patients taking a combination of simvastatin, which is used in the controversial cholesterol drug Vytorin, and the heart-rhythm medication amiodarone Source: money.cnn.com UPDATE 2-Sanofi boosted by priority review for Multaq drug - Reuters LONDON, Aug 8 (Reuters) - Sanofi-Aventis's (SASY.PA: Quote , Profile , Research , Stock Buzz ) experimental heart drug Multaq, which some analysts believe could be worth more than $2 billion in sales a year, is to get a priority review from the U.S Source: www.reuters.com FDA: Some cholesterol and heart drugs don't mix - Forbes Patients taking some common medications for high cholesterol and irregular heart beats can suffer severe muscle damage because of a problem in the way the drugs interact, the government warned on Friday. The Food and Drug Administration said doctors Source: www.forbes.com U.S. says conflict over anthrax vaccine motivated suspect - International Herald Tribune U.S. says conflict over anthrax vaccine motivated suspect - International Herald Tribune
WASHINGTON : Dozens of members of Congress were demanding an "immediate halt" to the Pentagon's mandatory anthrax vaccination effort. Military personnel, under the threat of court-martial, were refusing to submit to the inoculations. The vaccine's Source: www.iht.com Costco decides to post FDA mercury advice about seafood - MSN MoneyCentral Costco Wholesale has agreed to post Food and Drug Administration advice about mercury at seafood counters in stores nationwide. The company's decision is a response to member requests and the advocacy efforts of ocean conservation group Oceana, said Source: news.moneycentral.msn.com FDA: Some cholesterol and heart drugs don't mix - Hanford Sentinel WASHINGTON - Patients taking some common medications for high cholesterol and irregular heart beats can suffer severe muscle damage because of a problem in the way the drugs interact, the government warned on Friday. The Food and Drug Administration Source: www.hanfordsentinel.com FDA On Pace To Approve 18 New Drugs In 2008 - CNN Money WASHINGTON -(Dow Jones)- The U.S. Food and Drug Administration has approved nine new medicines as of the end of June, putting it on pace to be one of the slowest years for new drug approvals in the last five years. Drugs approved this year include Source: money.cnn.com Daily checkup - Lexington Herald-Leader Patients taking some common medications for high cholesterol and irregular heartbeats can suffer severe muscle damage because of a problem in the way the drugs interact, the government warned Friday. The Food and Drug Administration said doctors Source: www.kentucky.com The FDA's Black Box - Forbes A new anesthesia drug was supposed to be the gem in Schering-Plough 's $14 billion purchase of rival Organon. Schering CEO Fred Hassan told analysts he expected the medicine, used to quickly reverse other drugs that cause paralysis, to "transform Source: www.forbes.com E. coli threat spurs new beef recall - Seattle Times Nebraska Beef Ltd. is recalling 1. 2 million pounds of beef because the products may be contaminated with E. coli bacteria. The recall comes a Omaha, Neb. Nebraska Beef Ltd. is recalling 1.2 million pounds of beef because the products may be Source: seattletimes.nwsource.com Patients taking Zocor or Vytorin and a heart rhythm drug can suffer - Newsday WASHINGTON (AP) _ Patients taking some common medications for high cholesterol and irregular heart beats can suffer severe muscle damage because of a problem in the way the drugs interact, the government warned on Friday. The Food and Drug Source: www.newsday.com UPDATE 1-Zeltia jumps on ovarian cancer drug news - Forbes MADRID, Aug 7 (Reuters) - Spanish pharmaceutical firm Zeltia said on Thursday it would seek regulatory approval for the use of its Yondelis drug to treat ovarian cancer after good results from final trials, sending the stock soaring. Zeltia would Source: www.forbes.com Living with Fibromyalgia, Drugs Approved to Manage Pain Living with Fibromyalgia, Drugs Approved to Manage Pain
A second drug has been approved to treat fibromyalgia, a painful chronic condition that affects the muscles and joints. Stronger Warnings Requested for Fluoroquinolones FDA has notified manufacturers of fluoroquinolones that a boxed warning on the increased risk of tendinitis and tendon rupture is necessary. FDA Warns Consumers About Potential Problems at Two Baltimore Pharmacies The U.S. Food and Drug Administration is warning consumers who filled prescriptions at The Medicine Shoppe pharmacies located at 8035A Liberty Road and 5900 Reisterstown Road in Baltimore that they may have received drugs that were either expired or suspected counterfeit. The FDA is particularly concerned because a number of the drugs are for serious diseases and could have an adverse effect on treatment. Prepare for Hurricanes and Floods: Advice From FDA This updated article gives tips on how to keep food, medical products, and pets safe during an emergency. Beware of Bug Bites and Stings Ticks, mosquitoes, and bees--here are tips for preventing and treating bug bites and stings. Making Sense of Vytorin Concerns Making Sense of Vytorin Concerns
This article clarifies the results of a study that was published in the New England Journal of Medicine, and emphasizes the importance of continuing on prescribed cholesterol medications. Resolved Drug Shortage: Digoxin oral tablets See website for more information about this resolved shortage. Pet Food Products Seized at PETCO Distribution Center Consumers who bought animal food products from PETCO in 16 states should take certain precautions FDA Warns Consumers About Potential Problems at Two Baltimore Pharmacies The U.S. Food and Drug Administration is warning consumers who filled prescriptions at The Medicine Shoppe pharmacies located at 8035A Liberty Road and 5900 Reisterstown Road in Baltimore that they may have received drugs that were either expired or suspected counterfeit. The FDA is particularly concerned because a number of the drugs are for serious diseases and could have an adverse effect on treatment. FDA: Some cholesterol and heart drugs don't mix - NWITimes.com FDA: Some cholesterol and heart drugs don't mix - NWITimes.com
WASHINGTON - Patients taking some common medications for high cholesterol and irregular heart beats can suffer severe muscle damage because of a problem in the way the drugs interact, the government warned on Friday. The Food and Drug Administration Source: nwitimes.com FDA OKs Flu Vaccines for 2008-09 Season - Atlanta Journal Constitution TUESDAY, Aug. 5 (HealthDay News) -- With the memory of last season's flu vaccine mismatch still fresh, U.S. health officials announced Tuesday that they have approved vaccines for the 2008-09 season that include new strains of the virus most likely Source: www.ajc.com The FDA's Black Box - Forbes A new anesthesia drug was supposed to be the gem in Schering-Plough 's $14 billion purchase of rival Organon. Schering CEO Fred Hassan told analysts he expected the medicine, used to quickly reverse other drugs that cause paralysis, to "transform Source: www.forbes.com U.S. FDA Licenses ADMET Predictor(TM) from Simulations Plus - Forbes Simulations Plus, Inc. (NASDAQ: SLP), a leading provider of software for pharmaceutical discovery and development, today announced that it has received a purchase order from the U.S. Food and Drug Administration (FDA) to license the Company's ADMET Source: www.forbes.com FDA warning issued on drug combinations - Arizona Daily Star WASHINGTON — Patients taking some common medications for high cholesterol and irregular heartbeats can suffer severe muscle damage because of a problem in the way the drugs interact, the government warned on Friday. The Food and Drug Administration Source: www.azstarnet.com FDA: Two local pharmacies sold expired medications - Baltimore Sun The Food and Drug Administration says two Baltimore pharmacies sold prescription medications that were expired or suspected to be fake. The medications were sold by the Medicine Shoppe pharmacies at 8035A Liberty Road and 5900 Reisterstown Road. The Source: www.baltimoresun.com 2nd UPDATE: FDA Alerts On Muscle-Injury Risk Tied To 2 Drugs - CNN Money WASHINGTON -(Dow Jones)- Federal regulators continue to receive reports of muscle injury in patients taking a combination of simvastatin, which is used in the controversial cholesterol drug Vytorin, and the heart-rhythm medication amiodarone Source: money.cnn.com Meridian Co., Ltd. Issues Statement About FDA & Financials - MSN MoneyCentral Meridian Co., Ltd. (OTCBB: MRDAF) ( http://www.meridianmedical.ca ), a company engaged in the research, development, manufacturing, and sales of advanced medical devices, has issued the following statement regarding the continuing delay in FDA 510(k Source: news.moneycentral.msn.com Rize 2 The Occasion Capsules, Rose 4 Her Capsules Rize 2 The Occasion Capsules, Rose 4 Her Capsules
UPDATE - Voluntary nationwide recall of all lot numbers. FDA lab analysis found the products contained a potentially harmful, undeclared ingredient, thiomethisosildenafil. June 2008 Monthly Safety Labeling Summary of safety-related revisions to the BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, and ADVERSE REACTIONS sections of the Prescribing Information, plus Patient Package Inserts and Medication Guides. Sau-Sea Foods, Inc. Issues Allergy Alert on Undeclared Egg in Smoked Salmon Spread in 7.5 Ounce Plastic Tub With Snap Lid (July 18) Sau-Sea foods, Inc, of Water Mill NY is recalling all tubs of SMOKED SALMON Spread with the sell by dates as follows: 072308, 082708, 092408, 1 12508, 03 1309. People who have an allergy or severe sensitivity to egg run the risk of serious or life threatening allergic reaction if they consume these products. Mitoxantrone Hydrochloride (marketed as Novantrone and generics) Post-marketing safety study shows poor adherence to cardiac monitoring recommendations in clinical practice. FDA is working with the manufacturers to educate healthcare providers to adhere to recommendations for patients with MS. Desmopressin Acetate (marketed as DDAVP Nasal Spray, DDAVP Rhinal Tube, DDAVP, DDVP, Minirin, and Stimate Nasal Spray) UPDATE - December 2007 Dear Healthcare Professional Letter and revised labeling (re: hyponatremia and seizures) added to previous alert. Current Drug Shortage: Proglycem (diazoxide) oral suspension Teva is managing inventory and can provide product from their emergency supply. Orders for Proglycem can be made during regular business hours (8am to 5pm Eastern, Monday through Friday) by calling Customer Service at 800-545-8800. Emergency requests can be made after hours by calling 800-795-2652 Domega International Co., Ltd. Issues an Alert on Undeclared Sulfites in Korica Brand Mut Gung Sweetened Ginger (July 16) The recalled Korica Brand Mut Gung Sweetened Ginger is sold in uncoded 7 oz plastic tubs and is a product of Vietnam. The product was sold nationwide. Simvastatin Used With Amiodarone Risk of rhabdomyolysis when simvastatin is used with amiodarone, particularly with simvastatin doses greater than 20 mg daily. Manufacturer for Wegmans Brand Sorbet Issues an Allergen Alert for Undeclared Milk on a Limited Number of Wegmans Brand Sorbets (July 31) The manufacturer of Wegmans Sorbet is recalling a limited number of 16 oz. Wegmans brand Sorbets because they may contain undeclared milk. People who have an allergy to milk run the risk of a serious or possible life-threatening allergic reaction if they consume the affected products. Roxane Laboratories, Inc. Initiates a Nationwide Voluntary Recall of Two Manufacturing Lots of Sodium Polystyrene Sulfonate Suspension in the US and Puerto Rico (July 14) Roxane Laboratories, Inc. announced today that it is conducting a nationwide voluntary recall of two manufacturing lots of Sodium Polystyrene Sulfonate Suspension, USP, 15 g/60 mL Unit dose bottles (NDC 0054-0165-51; Lot 856396A Exp April 2010, and Lot 856693A Exp May 2010). C.F. Sauer Foods Issues Allergy Alert on Undeclared Milk in one lot of Gold Medal Spaghetti Sauce Mix (August 4) C.F. Sauer Foods Issues Allergy Alert on Undeclared Milk in one lot of Gold Medal Spaghetti Sauce Mix (August 4)
CF Sauer Foods Inc, of Richmond, VA is recalling all packages of Gold Medal Spaghetti Sauce Mix with the code date as follows: 8119R. People who have an allergy or severe sensitivity to milkrun the risk of serious or life threatening allergic reaction if they consume these products. Jack Distribution, LLC. Issues a Voluntary Nationwide Recall of Select Lots of Rize 2 The Occasion Capsules and Rose 4 Her Capsules (July 1) Jack Distribution, LLC, and its wholesale distributors G and N Works, Inc., and Devine Distribution, Inc., announced today that they are conducting a voluntary nationwide recall of the following lot numbers of the company's supplement products sold under the brand names Rize 2 The Occasion and Rose 4 Her. (Rize 2 lot numbers CG-84 expires 11/10, GD-98 expires 08/10, CC-06 expires 06/10, 709 expires 09/10, CG-79 expires 11/10) (Rose 4 Her lot number CG-78 expires 11/10). Salmolux Inc. Recalls Wild Alaskan Smoked Salmon Nova Lox Lot # 01418 Because of Possible Health Risk (July 9) Salmolux Inc. of Federal Way, WA, is recalling lot # 01418 of its Wild Alaskan Smoked Salmon Nova Lox sold in 3 ounce packages due to the potential to be contaminated with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Giant Food Alerts Customers to Voluntary Recall of Giant Brand Garlic Bread and Garlic Spread (June 27) Giant Food Alerts Customers to Voluntary Recall of Giant Brand Garlic Bread and Garlic Spread (June 27)
Giant Food has announced a voluntary recall of Giant brand garlic bread and garlic spread products sold in its Bakeshop as the items contain milk products which are not declared on the labels. Giant removed from its shelves all 16 ounce packages of Giant brand garlic bread and all 16 ounce packages of Giant brand garlic spread products. Lucky Green Trading, Inc. Recalls Thai Basil Because of Possible Health Risk (July 9) LUCKY GREEN TRADING, INC. of Garden Grove, CA is recalling Thai Basil , because it has the potential to be contaminated with Salmonella , an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. EG Labs Announces Urgent Nationwide Voluntary Recall of ALL LOTS of Viapro 375 mg Capsules, due to a Potentially Harmful Ingredient EG Labs, LLC, announced today that it is conducting a nationwide voluntary recall of all lots of its supplement product sold under the brand name, Viapro, in 375mg capsules. EG Labs, LLC. is conducting this recall after being informed by representatives of the Food and Drug Administration (FDA) that lab analysis by FDA of a sample from one lot of the product revealed that it contained a potentially harmful undeclared ingredient, thio-methisosildenafil. FDA Consumer Corner: Nonoxynol 9 Contraceptives: No Protection against HIV and Other STDs The Food and Drug Administration wants to be sure that consumers know about new warnings on over-the-counter vaginal contraceptive products that contain the spermicide ingredient nonoxynol 9 (N9). These products include spermicidal gels, foams, film... Desmopressin Acetate (marketed as DDAVP Nasal Spray, DDAVP Rhinal Tube, DDAVP, DDVP, Minirin, and Stimate Nasal Spray) UPDATE - December 2007 Dear Healthcare Professional Letter and revised labeling (re: hyponatremia and seizures) added to previous alert. Domega International Co., Ltd. Issues an Alert on Undeclared Sulfites in Korica Brand Mut Gung Sweetened Ginger (July 16) The recalled Korica Brand Mut Gung Sweetened Ginger is sold in uncoded 7 oz plastic tubs and is a product of Vietnam. The product was sold nationwide. August 8, 2008FDA Announces Improved Policies Regarding Transparency, Public Disclosure for Advisory Committees FDA Announces Improved Policies Regarding Transparency, Public Disclosure for Advisory Committees
The Food and Drug Administration today announced several improved policies and procedures strengthening its management of FDA advisory committees. The improvements include stricter limits on financial conflicts of interest for committee members, improved voting procedures, and improvements to the processes for disclosing information pertaining both to advisory committee members and to specific matters considered at advisory committee meetings. FDA Advises Against Consumption of American Lobster (Maine Lobster) Tomalley The U.S. Food and Drug Administration today warned consumers to avoid eating tomalley in American Lobster (Maine Lobster), regardless of where the lobster was harvested, because of potential contamination with dangerous levels of the toxins that cause Paralytic Shellfish Poisoning (PSP). FDA Warns Consumers About Potential Problems at Two Baltimore Pharmacies The U.S. Food and Drug Administration is warning consumers who filled prescriptions at The Medicine Shoppe pharmacies located at 8035A Liberty Road and 5900 Reisterstown Road in Baltimore that they may have received drugs that were either expired or suspected counterfeit. The FDA is particularly concerned because a number of the drugs are for serious diseases and could have an adverse effect on treatment. Preventing Medical Errors: Danger Giving Topical Thrombin Intravascularly The Institute for Safe Medication Practices (ISMP) recently warned about the dangers of accidentally giving topical thrombin intravascularly. Thrombin applied topically can help stop oozing blood and minor bleeding from capillaries and small veins. ... Federal Agents Seize more than $24 Million in Unapproved New Drugs Representatives of the U.S. Food and Drug Administration and the U.S. Marshals Service today seized $24.2 million worth of unapproved new drugs from KV Pharmaceutical Company of St. Louis, Mo. Agents acted after United States Attorney Catherine L. Hanaway filed a civil forfeiture suit and obtained a warrant to seize the unapproved new drug products being made by KV Pharmaceutical. Drug Shortages: Drugs to be Discontinued; Geref Diagnostic EMD Serono has made a business decision to discontinue this product. 2nd UPDATE: FDA Alerts On Muscle-Injury Risk Tied To 2 Drugs - CNN Money 2nd UPDATE: FDA Alerts On Muscle-Injury Risk Tied To 2 Drugs - CNN Money
WASHINGTON -(Dow Jones)- Federal regulators continue to receive reports of muscle injury in patients taking a combination of simvastatin, which is used in the controversial cholesterol drug Vytorin, and the heart-rhythm medication amiodarone Source: money.cnn.com FDA warns of muscle harm when heart drugs combined - Reuters WASHINGTON (Reuters) - U.S. health officials warned the public on Friday about the risk of a rare type of muscle injury seen when the cholesterol drug simvastatin is combined with the anti-arrhythmia medicine amiodarone. The Food and Drug Source: www.reuters.com New oversight of U.S. produce industry slow in coming - San Diego Union-Tribune WASHINGTON – The fresh produce industry in the United States is ready to finally embrace greater oversight after weathering the worst foodborne outbreak in a decade, but sweeping change is unlikely to come any time soon. In just the latest outbreak Source: www.signonsandiego.com FDA warns that some cholesterol and heart drugs don't mix - Canada East WASHINGTON - The U.S. government says patients taking some common medications for high cholesterol and irregular heart beats can suffer severe muscle damage because of a problem in the way the drugs interact. The Food and Drug Administration warned Source: www.canadaeast.com Erythropoiesis Stimulating Agents (ESAs) - Epoetin alfa (marketed as Procrit, Epogen), Darbepoetin alfa (marketed as Aranesp) Erythropoiesis Stimulating Agents (ESAs) - Epoetin alfa (marketed as Procrit, Epogen), Darbepoetin alfa (marketed as Aranesp)
UPDATE - Dear Healthcare Professional letter added. Current Drug Shortage: Proglycem (diazoxide) oral suspension Teva is managing inventory and can provide product from their emergency supply. Orders for Proglycem can be made during regular business hours (8am to 5pm Eastern, Monday through Friday) by calling Customer Service at 800-545-8800. Emergency requests can be made after hours by calling 800-795-2652 Viapro 375mg Capsules Product recalled because it was found to contain a potentially harmful analog of Sildenafil. Rize 2 The Occasion Capsules, Rose 4 Her Capsules UPDATE - Voluntary nationwide recall of all lot numbers. FDA lab analysis found the products contained a potentially harmful, undeclared ingredient, thiomethisosildenafil. Preventing Medical Errors: Danger Giving Topical Thrombin Intravascularly The Institute for Safe Medication Practices (ISMP) recently warned about the dangers of accidentally giving topical thrombin intravascularly. Thrombin applied topically can help stop oozing blood and minor bleeding from capillaries and small veins. ... Recalls and Safety Alerts: Cellcept and Myfortic Linked to Birth Defects and Fetal Loss FDA is advising healthcare professionals about an increased risk of fetal harm when women become pregnant while being treated with the immunosuppressant drugs Cellcept (mycophenolate mofetil) or Myfortic (mycophenolic acid). Myfortic is approved t... Micro-bubble Contrast Agents (marketed as Definity (Perflutren Lipid Microsphere) Injectable Suspension and Optison (Perflutren Protein-Type A Microspheres for Injection) Changes to the Boxed Warning, Warnings, and Contraindications sections of the prescribing information to reflect conclusions of FDA reviews of information received following the addition of new contraindications and warnings in October 2007. Recalls and Safety Alerts: Warning Added to Regranex Label A boxed warning alerting healthcare professionals to an increased risk of cancer death has been added to the labeling for Regranex (becaplermin), a topical medication used to treat certain diabetic foot and leg ulcers. Based on a review of an ea... August 2008 Patient Safety News Video news show for healthcare professionals, covering safety alerts, recalls, product approvals, and important tips on protecting patients. Living with Fibromyalgia, Drugs Approved to Manage Pain Living with Fibromyalgia, Drugs Approved to Manage Pain
A second drug has been approved to treat fibromyalgia, a painful chronic condition that affects the muscles and joints. FDA 101: Dietary Supplements Part of the "FDA 101" series, this article describes how dietary supplements are regulated and offers safety tips for consumers. Vita Food Products Issues Alert Regarding Vita Nova Salmon (July 25) The product that is the subject of this public announcement and recall are packages (deep dark blue in color) of smoked salmon that bear the Vita logo in the upper left corner on the part of the packaging that is immediately visible to the consumer. Each package contains 4-10 bacon-style slices (total 3 oz.) of smoked salmon; the slices are contained in a vacuum pack within a box that is 4" wide by 7.5" in length by 1/2" in thickness. IMPORTANT: The Code Date of 11/16/08 198 is on the left end flap of each package. This announcement and recall only applies to packages that bear that CODE DATE. Radiology and Children: Extra Care Required Image Gently, a campaign launched this year, aims to raise awareness about opportunities to lower the radiation dose during the medical imaging of children. Stay Healthy While Traveling Abroad Getting sick can ruin your trip. FDA shares the guidance it gives to overseas inspectors to help them remain healthy while traveling abroad. Grande Produce, LTD.CO Recalls Jalapeno Peppers, Serrano Peppers, and Avocados Because of Possible Health Risk (July 19) The Jalapeno Peppers, Serrano Peppers and Avocados were distributed to the following states: TX, DE, NC, GA, OK, IA, MN, IL, FL, IN, MD, NY, MS, AR, KS, and KY. The avocados being recalled were shipped in boxes labeled "Frutas Finas de Tancitaro HASS Avocados, Produce of Mexico," all sizes, with lot number HUE08160090889. The Jalapeno Peppers and Serrano peppers being recalled were shipped in 35lb. plastic crates with no brand name or label. Are You Storing Food Safely? When, where, and how you store food can help prevent foodborne illnesses. Here are pointers for safely storing food in your refrigerator, freezer, and cupboards. Beware of Bug Bites and Stings Ticks, mosquitoes, and bees--here are tips for preventing and treating bug bites and stings. Jack Distribution, LLC. Issues a Voluntary Nationwide Recall of Select Lots of Rize 2 The Occasion Capsules and Rose 4 Her Capsules (July 1) Jack Distribution, LLC, and its wholesale distributors G and N Works, Inc., and Devine Distribution, Inc., announced today that they are conducting a voluntary nationwide recall of the following lot numbers of the company's supplement products sold under the brand names Rize 2 The Occasion and Rose 4 Her. (Rize 2 lot numbers CG-84 expires 11/10, GD-98 expires 08/10, CC-06 expires 06/10, 709 expires 09/10, CG-79 expires 11/10) (Rose 4 Her lot number CG-78 expires 11/10). Pro-Pharmaceuticals Granted Pre-IND Meeting for Anti-Hypoxia Drug - MSN MoneyCentral Pro-Pharmaceuticals Granted Pre-IND Meeting for Anti-Hypoxia Drug - MSN MoneyCentral
Pro-Pharmaceuticals, Inc. PRW , a bio-pharmaceutical company developing proprietary polysaccharide-based therapeutic compounds in the treatment of cancer and fibrosis, today announced that a pre-Investigational New Drug (IND) meeting with the U.S Source: news.moneycentral.msn.com FDA schedules meeting on drug from Pfizer, Ligand - CNBC WASHINGTON - Federal medical advisers will meet next month to review an experimental drug to treat osteoporosis from Pfizer Inc. and Ligand Pharmaceuticals Inc. The Food and Drug Administration said Wednesday its panel of reproductive drug experts Source: www.cnbc.com Injected Drug Approved for High Blood Pressure - Atlanta Journal Constitution MONDAY, Aug. 4 (HealthDay News) -- The U.S. Food and Drug Administration has approved Cleviprex (clevidipine butyrate), an injected drug to treat high blood pressure. Produced by the Medicines Co. of Parsippany, N.J., the drug is to be prescribed Source: www.ajc.com Cipher Pharmaceuticals announces U.S. distribution and supply - Forbes MISSISSAUGA, ON, Aug. 6 /PRNewswire-FirstCall/ - Cipher Pharmaceuticals Inc. (TSX: DND) ("Cipher" or "the Company") today announced that it has entered into a definitive development, distribution and supply agreement with Ranbaxy Pharmaceuticals Inc Source: www.forbes.com Sausages biggest sellers for vegan company, Field Roast - Seattle Times Martha Jacihto, right, grabs smoked tomato deli slices for sorting as they are cut in the new facilities of Field Roast Grain Meat in Seattle. In the background is Nhung Nguyen, who is arranging more rolls of smoked tomato to be cut. ELLEN M. BANNER Source: seattletimes.nwsource.com The Truth About 7 Common Food Additives - CBS News (WebMD) If, like many Americans, you stock your pantry with processed foods, you may worry about how safe food additives really are. Over the years, the safety of many food additives, from food dyes to trans fats, has come into question. A scare over Source: www.cbsnews.com PDA and FDA to Host Conference on Ensuring the Integrity of - EIN News Bethesda, Md. (August 5, 2008): The Parenteral Drug Association (PDA) announced today that together with the US Food and Drug Administration (US FDA), it will host the PDA/FDA Pharmaceutical Ingredient Supply Chain Conference in Washington, D.C Source: www.einnews.com Alkermes alcohol drug gets Russian approval - Boston Globe A drug to treat alcoholism, manufactured by Alkermes Inc. has received marketing approval in Russia, the Cambridge-based company said today. Russian regulatory authorities approved the marketing of Vivitrol, a once-monthly, extended-release Source: www.boston.com Loophole in tobacco bill favors industry - Boston Globe Loophole in tobacco bill favors industry - Boston Globe
WASHINGTON - A loophole in a sweeping tobacco regulation bill would give the industry a 21-month window to introduce some new products without first getting federal approval. The House last month overwhelmingly passed the legislation, which for the Source: www.boston.com Cleveland BioLabs Receives Notice of Allowance From FDA to Commence - MSN MoneyCentral Cleveland BioLabs, Inc. (NASDAQ: CBLI) announced today the allowance from the U.S. Food and Drug Administration (FDA) to begin Phase I clinical trials in human volunteers with Protectan CBLB502, a drug under development for the treatment for Acute Source: news.moneycentral.msn.com FDA gives priority review to Sanofi's Multaq - PR Inside PARIS (AP) - U.S. regulators have given priority review status to Sanofi-Aventis' experimental Multaq treatment for irregular heartbeat, a ruling that could help speed the drug's launch, the French pharmaceutical company said Friday. Drugs given the Source: www.pr-inside.com FDA approves Vapotherm device - Baltimore Sun Vapotherm Inc., a Stevensville -based maker of respiratory devices that struggled for more than a year without revenue after voluntarily recalling the machines, announced yesterday that the Food and Drug Administration has approved an upgraded Source: www.baltimoresun.com FDA schedules meeting on drug from Pfizer, Ligand - Boston Globe WASHINGTON— Federal medical advisers will meet next month to review an experimental drug to treat osteoporosis from Pfizer Inc. and Ligand Pharmaceuticals Inc. The Food and Drug Administration said Wednesday its panel of reproductive drug experts Source: www.boston.com Former Michigan defensive end Rondell Biggs faces steroid charge - Detroit Free Press A former Michigan football player will have a preliminary examination in an Ann Arbor court next week after being caught with steroids in January. Rondell Biggs, 24, a defensive end for the Wolverines in 2003-06, is scheduled to appear in Ann Arbor's Source: www.freep.com Sweeping tobacco regulation bill has loophole - Forbes A loophole in a sweeping tobacco regulation bill would give the industry a 21-month window to introduce certain new products without first getting federal approval. The House last month overwhelmingly passed the legislation, which for the first time Source: www.forbes.com Loophole in tobacco regulation bill - Arizona Daily Star WASHINGTON — A loophole in a sweeping tobacco regulation bill would give the industry a 21-month window to introduce some new products without first getting federal approval. The House last month overwhelmingly passed the legislation, which for the Source: www.azstarnet.com Discovery Labs Reports Progress in Responding to Surfaxin FDA - MSN MoneyCentral WARRINGTON, Pa., Aug. 6, 2008 (PRIME NEWSWIRE) -- Discovery Laboratories, Inc. (Nasdaq:DSCO) announces that it has made significant progress in addressing key remaining requirements identified by the U.S. Food and Drug Administration (FDA) to gain Source: news.moneycentral.msn.com The FDA guerillas of wonky DrugWonks -- part 1 - Online Journal Former Bush administration officials have formed a pharmaceutical industry guerilla group called the Center for Medicine in the Public Interest (CMPI), described on its website as “a non-partisan, non-profit educational charity,” and a “new Source: onlinejournal.com FDA schedules meeting on drug from Pfizer, Ligand - Boston Globe FDA schedules meeting on drug from Pfizer, Ligand - Boston Globe
WASHINGTON— Federal medical advisers will meet next month to review an experimental drug to treat osteoporosis from Pfizer Inc. and Ligand Pharmaceuticals Inc. The Food and Drug Administration said Wednesday its panel of reproductive drug experts Source: www.boston.com Loophole in tobacco regulation bill would allow some new product sales - Minneapolis Star Tribune WASHINGTON - A loophole in a sweeping tobacco regulation bill would give the industry a 21-month window to introduce certain new products without first getting federal approval. The House last month overwhelmingly passed the legislation, which for Source: www.startribune.com Campaign 2008 - American Reporter ORINDA, Calif. -- Albert described himself. "I'm a hopeless case. "I've tried every antidepressant, and none of them works for me." Yet he had never taken an MAOI antidepressant drug. He knew almost nothing about them. Many depressed patients feel Source: www.american-reporter.com Mix-ups spur FDA to do more to avoid sound-alike medications - Newark Star-Ledger Three years ago, Johnson & Johnson changed the name of its Alzheimer's drug Reminyl because it was being confused by doctors and pharmacists with the diabetes medicine Amaryl. Mix-ups were linked to two deaths and some serious health problems for Source: www.nj.com August 7, 2008Loophole in tobacco bill favors industry - Boston Globe Loophole in tobacco bill favors industry - Boston Globe
WASHINGTON - A loophole in a sweeping tobacco regulation bill would give the industry a 21-month window to introduce some new products without first getting federal approval. The House last month overwhelmingly passed the legislation, which for the Source: www.boston.com Daily Briefing - Atlanta Journal Constitution German automaker BMW AG said Thursday that global sales of its vehicles rose 2.2 percent in July, with its BMW, Mini and Rolls-Royce brands posting increases. In a nod to buyers looking for more fuel efficiency, the company also said sales of its Source: www.ajc.com Former Biopure Executive To Settle SEC Allegations - Wall Street Journal A former Biopure Corp. executive agreed to pay a $150,000 civil penalty to settle allegations that he misled investors about the Massachusetts biotech company's prospects for obtaining regulatory approval for its synthetic blood product, Hemopure Source: online.wsj.com FDA Announces Improved Policies Regarding Transparency, Public Disclosure for Advisory Committees FDA Announces Improved Policies Regarding Transparency, Public Disclosure for Advisory Committees
The Food and Drug Administration today announced several improved policies and procedures strengthening its management of FDA advisory committees. The improvements include stricter limits on financial conflicts of interest for committee members, improved voting procedures, and improvements to the processes for disclosing information pertaining both to advisory committee members and to specific matters considered at advisory committee meetings. Federal Agents Seize more than $24 Million in Unapproved New Drugs Representatives of the U.S. Food and Drug Administration and the U.S. Marshals Service today seized $24.2 million worth of unapproved new drugs from KV Pharmaceutical Company of St. Louis, Mo. Agents acted after United States Attorney Catherine L. Hanaway filed a civil forfeiture suit and obtained a warrant to seize the unapproved new drug products being made by KV Pharmaceutical. Resolved Drug Shortage: Digoxin oral tablets See website for more information about this resolved shortage. FDA Clears Test that Helps Identify Type of Cancer in Tumor Sample The U.S. Food and Drug Administration has cleared for marketing a test that can help health care professionals determine what type of cancer cells are present in a malignant tumor. The Pathwork Tissue of Origin test compares the genetic material of a patient's tumor with genetic information on malignant tumor types stored in a database. Preventing Medical Errors: Danger Giving Topical Thrombin Intravascularly The Institute for Safe Medication Practices (ISMP) recently warned about the dangers of accidentally giving topical thrombin intravascularly. Thrombin applied topically can help stop oozing blood and minor bleeding from capillaries and small veins. ... Desmopressin Acetate (marketed as DDAVP Nasal Spray, DDAVP Rhinal Tube, DDAVP, DDVP, Minirin, and Stimate Nasal Spray) Desmopressin Acetate (marketed as DDAVP Nasal Spray, DDAVP Rhinal Tube, DDAVP, DDVP, Minirin, and Stimate Nasal Spray)
UPDATE - December 2007 Dear Healthcare Professional Letter and revised labeling (re: hyponatremia and seizures) added to previous alert. Making Sense of Vytorin Concerns This article clarifies the results of a study that was published in the New England Journal of Medicine, and emphasizes the importance of continuing on prescribed cholesterol medications. Warnings on Raw Jalapeño and Serrano Peppers from Mexico Until further notice, FDA is advising consumers to avoid raw serrano peppers from Mexico, in addition to raw jalapeño peppers from Mexico, and any foods that contain them. Drug Shortage: MVI Adult InjectableFDA Announces Improved Policies Regarding Transparency, Public Disclosure for Advisory Committees FDA Announces Improved Policies Regarding Transparency, Public Disclosure for Advisory Committees
The Food and Drug Administration today announced several improved policies and procedures strengthening its management of FDA advisory committees. The improvements include stricter limits on financial conflicts of interest for committee members, improved voting procedures, and improvements to the processes for disclosing information pertaining both to advisory committee members and to specific matters considered at advisory committee meetings. FDA 101: Dietary Supplements Part of the "FDA 101" series, this article describes how dietary supplements are regulated and offers safety tips for consumers. FDA 101: Advisory Committees FDA's Advisory Committees are critical to the agency's product review process. Find out the basics of putting special government employees with different perspectives on such scientific committees. Federal Agents Seize more than $24 Million in Unapproved New Drugs Representatives of the U.S. Food and Drug Administration and the U.S. Marshals Service today seized $24.2 million worth of unapproved new drugs from KV Pharmaceutical Company of St. Louis, Mo. Agents acted after United States Attorney Catherine L. Hanaway filed a civil forfeiture suit and obtained a warrant to seize the unapproved new drug products being made by KV Pharmaceutical. Resolved Drug Shortage: Digoxin oral tablets Resolved Drug Shortage: Digoxin oral tablets
See website for more information about this resolved shortage. Recalls and Safety Alerts: Cellcept and Myfortic Linked to Birth Defects and Fetal Loss FDA is advising healthcare professionals about an increased risk of fetal harm when women become pregnant while being treated with the immunosuppressant drugs Cellcept (mycophenolate mofetil) or Myfortic (mycophenolic acid). Myfortic is approved t... Drug Shortage: MVI Adult Injectable Hospira information updated. Electronic Medical Devices Possible malfunction of Electronic Medical Devices caused by Computed Tomography (CT) Scanning on patients with implanted and external electronic medical devices. Preventing Medical Errors: Potential Problems with Insulin Pens in Hospitals In a recent article, the Institute for Safe Medication Practices (ISMP) highlighted several potential safety problems when hospitals switch from multiple dose vials of insulin to insulin pens. ISMP points out that there are certain safety advant... Drug Shortages: Drugs to be Discontinued; Geref Diagnostic EMD Serono has made a business decision to discontinue this product. Erythropoiesis Stimulating Agents (ESAs) - Epoetin alfa (marketed as Procrit, Epogen), Darbepoetin alfa (marketed as Aranesp) FDA clarifies approved conditions for use of ESAs in patients with cancer and revises dosing directions for the products. Drug Shortage: Fentanyl transdermal patch Availability information updated. Preventing Medical Errors: Danger Giving Topical Thrombin Intravascularly The Institute for Safe Medication Practices (ISMP) recently warned about the dangers of accidentally giving topical thrombin intravascularly. Thrombin applied topically can help stop oozing blood and minor bleeding from capillaries and small veins. ... Viapro 375mg Capsules Product recalled because it was found to contain a potentially harmful analog of Sildenafil. Levitronix CentriMag Extracorporeal Blood Pumping System: CentriMag Primary Console (with v200 Application Software) Levitronix CentriMag Extracorporeal Blood Pumping System: CentriMag Primary Console (with v200 Application Software)
Physicians warned not to use Blood Pumping System with Valleylab Force FX-C or SSE2L electrosurgery devices because use may result in stoppage of the pump and may cause serious injury or death. Micro-bubble Contrast Agents (marketed as Definity (Perflutren Lipid Microsphere) Injectable Suspension and Optison (Perflutren Protein-Type A Microspheres for Injection) Changes to the Boxed Warning, Warnings, and Contraindications sections of the prescribing information to reflect conclusions of FDA reviews of information received following the addition of new contraindications and warnings in October 2007. Recalls and Safety Alerts: Warning Added to Regranex Label A boxed warning alerting healthcare professionals to an increased risk of cancer death has been added to the labeling for Regranex (becaplermin), a topical medication used to treat certain diabetic foot and leg ulcers. Based on a review of an ea... Mitoxantrone Hydrochloride (marketed as Novantrone and generics) Post-marketing safety study shows poor adherence to cardiac monitoring recommendations in clinical practice. FDA is working with the manufacturers to educate healthcare providers to adhere to recommendations for patients with MS. Rize 2 The Occasion Capsules, Rose 4 Her Capsules UPDATE - Voluntary nationwide recall of all lot numbers. FDA lab analysis found the products contained a potentially harmful, undeclared ingredient, thiomethisosildenafil. Pet Food Products Seized at PETCO Distribution Center Consumers who bought animal food products from PETCO in 16 states should take certain precautions Abacavir (marketed as Ziagen) and Abacavir-containing Medications Association between HLA-B*5701 allele and hypersensitivity reactions identified and patient screening for the allele recommended before starting or restarting treatment. Electronic Medical Devices Possible malfunction of Electronic Medical Devices caused by Computed Tomography (CT) Scanning on patients with implanted and external electronic medical devices. Living with Fibromyalgia, Drugs Approved to Manage Pain A second drug has been approved to treat fibromyalgia, a painful chronic condition that affects the muscles and joints. FDA advisers must abide by new financial limits - Boston Globe FDA advisers must abide by new financial limits - Boston Globe
WASHINGTON— Outside experts may not participate in federal advisory committee meetings on drugs and medical devices if they have more than a $50,000 financial interest in the companies governed by their decisions, according to new guidelines Source: www.boston.com FDA approvals clear way for flu vaccine marketing - Centre For Infectious Disease Research and Policy Aug 6, 2008 (CIDRAP News) – The six companies that make influenza vaccine for the US market have won federal approval for their version of this year's vaccine, in which all three flu strains used in last year's product have been replaced, the Food Source: www.cidrap.umn.edu August 6, 2008Sage Products Inc. Issues Voluntary Recall of 2% Chlorhexidine Gluconate Cloth Patient Preoperative Skin Preparation (June 27) Sage Products Inc. Issues Voluntary Recall of 2% Chlorhexidine Gluconate Cloth Patient Preoperative Skin Preparation (June 27)
As a precautionary measure, Sage Products announced a voluntary recall of limited lots of 2 Percent Chlorhexidine Gluconate (CHG) Cloth Patient Preoperative Skin Preparation product. Testing of bulk 2 Percent CHG solution from an outside supplier was found positive for Burkholderia cepacia (B. cepacia). Domega International Co., Ltd. Issues an Alert on Undeclared Sulfites in Korica Brand Mut Gung Sweetened Ginger (July 16) The recalled Korica Brand Mut Gung Sweetened Ginger is sold in uncoded 7 oz plastic tubs and is a product of Vietnam. The product was sold nationwide. Current Drug Shortage: Proglycem (diazoxide) oral suspension Teva is managing inventory and can provide product from their emergency supply. Orders for Proglycem can be made during regular business hours (8am to 5pm Eastern, Monday through Friday) by calling Customer Service at 800-545-8800. Emergency requests can be made after hours by calling 800-795-2652 FDA Consumer Corner: Nonoxynol 9 Contraceptives: No Protection against HIV and Other STDs The Food and Drug Administration wants to be sure that consumers know about new warnings on over-the-counter vaginal contraceptive products that contain the spermicide ingredient nonoxynol 9 (N9). These products include spermicidal gels, foams, film... Grande Produce, LTD.CO Recalls Jalapeno Peppers, Serrano Peppers, and Avocados Because of Possible Health Risk (July 19) The Jalapeno Peppers, Serrano Peppers and Avocados were distributed to the following states: TX, DE, NC, GA, OK, IA, MN, IL, FL, IN, MD, NY, MS, AR, KS, and KY. The avocados being recalled were shipped in boxes labeled "Frutas Finas de Tancitaro HASS Avocados, Produce of Mexico," all sizes, with lot number HUE08160090889. The Jalapeno Peppers and Serrano peppers being recalled were shipped in 35lb. plastic crates with no brand name or label. Agricola Zaragoza, Inc. Recalls Jalapeno Peppers Because of Possible Health Risk (July 21) The recall is a result of sampling by FDA, which revealed that these Jalapeno Peppers were contaminated with the same strain of Salmonella Saintpaul responsible for the current Salmonella outbreak. It is unknown at this time which, if any, of the more than 1,200 illnesses reported to date are related to this particular product or to the grower who supplied this product. Distribution of these products has been suspended while FDA, the Texas Department of State Health Services and the company continue their investigation as to the source of the problem. Recalls and Safety Alerts: Possible Association between TNF Blockers and Cancer Recalls and Safety Alerts: Possible Association between TNF Blockers and Cancer
FDA has informed healthcare professionals that it is investigating a possible association between drugs that block tumor necrosis factor (TNF) and the development of lymphoma and other cancers in children and young adults. This is part of FDA's ... FDA Approves First Generic Divalproex Sodium to Treat Seizures, Migraine Headaches and Bipolar Disorder The U.S. Food and Drug Administration today approved the first generic version of Depakote delayed-release tablets (divalproex sodium). Depakote is approved by the FDA for the treatment of seizures, bipolar disorder and migraine headaches. Pet Food Products Seized at PETCO Distribution Center Consumers who bought animal food products from PETCO in 16 states should take certain precautions Vyteris Announces Launch of Initiative to Pursue Joint Development - MSN MoneyCentral Vyteris Announces Launch of Initiative to Pursue Joint Development - MSN MoneyCentral
Vyteris, Inc . (OTC BB : VYTR), manufacturer of the first U.S. Food and Drug Administration (FDA)-approved active patch transdermal drug delivery system, announced an initiative to identify and target candidate drugs in the pain management field that Source: news.moneycentral.msn.com FDA Gives Approval to Blood Pressure Drug From Medicines Co. - dbtechno.com Washington (dbTechno) - Medicines Co. has received FDA approval to market their blood pressure drug, Cleviprex. The U.S. Food and Drug Administration (FDA) approved the blood pressure drug, which has been highly touted as something which could help Source: www.dbtechno.com Tomato Growers Seek Payback on Salmonella Scare: Cindy Skrzycki - Bloomberg Aug. 5 (Bloomberg) -- While throwing a few rotten tomatoes at U.S. regulators might help ease their economic pain, growers involved in the latest salmonella food epidemic would prefer cash for their trouble. After weeks of implicating domestic Source: www.bloomberg.com Radiology and Children: Extra Care Required Radiology and Children: Extra Care Required
Image Gently, a campaign launched this year, aims to raise awareness about opportunities to lower the radiation dose during the medical imaging of children. Are You Storing Food Safely? When, where, and how you store food can help prevent foodborne illnesses. Here are pointers for safely storing food in your refrigerator, freezer, and cupboards. Manufacturer for Wegmans Brand Sorbet Issues an Allergen Alert for Undeclared Milk on a Limited Number of Wegmans Brand Sorbets (July 31) The manufacturer of Wegmans Sorbet is recalling a limited number of 16 oz. Wegmans brand Sorbets because they may contain undeclared milk. People who have an allergy to milk run the risk of a serious or possible life-threatening allergic reaction if they consume the affected products. Prepare for Hurricanes and Floods: Advice From FDA This updated article gives tips on how to keep food, medical products, and pets safe during an emergency. Preventing Medical Errors: Danger Giving Topical Thrombin Intravascularly The Institute for Safe Medication Practices (ISMP) recently warned about the dangers of accidentally giving topical thrombin intravascularly. Thrombin applied topically can help stop oozing blood and minor bleeding from capillaries and small veins. ... Grande Produce, LTD.CO Recalls Jalapeno Peppers, Serrano Peppers, and Avocados Because of Possible Health Risk (July 19) The Jalapeno Peppers, Serrano Peppers and Avocados were distributed to the following states: TX, DE, NC, GA, OK, IA, MN, IL, FL, IN, MD, NY, MS, AR, KS, and KY. The avocados being recalled were shipped in boxes labeled "Frutas Finas de Tancitaro HASS Avocados, Produce of Mexico," all sizes, with lot number HUE08160090889. The Jalapeno Peppers and Serrano peppers being recalled were shipped in 35lb. plastic crates with no brand name or label. Preventing Medical Errors: Potential Problems with Insulin Pens in Hospitals In a recent article, the Institute for Safe Medication Practices (ISMP) highlighted several potential safety problems when hospitals switch from multiple dose vials of insulin to insulin pens. ISMP points out that there are certain safety advant... Bay Valley Foods Issues Allergy Alert on Undeclared Milk in Mislabeled Kroger Chicken Noodle Soup (June 24) The recalled product, Kroger Chicken Noodle Soup, comes in 10.5 ounce cans and is marked with lot code 52104098, and a "best before" date code of 40910 (April 9, 2010) that can be found on the bottom of the can. Consumers are urged to return the product to the store where it was purchased for a full refund. FDA Extends Consumer Warning on Serrano Peppers from Mexico Laboratory testing by the U.S. Food and Drug Administration has confirmed that both a sample of serrano pepper and a sample of irrigation water collected by agency investigators on a farm in the state of Nuevo Leon, Mexico, contain Salmonella Saintpaul with the same genetic fingerprint as the strain of bacteria that is causing the current outbreak in the United States. FDA 101: Dietary Supplements Part of the "FDA 101" series, this article describes how dietary supplements are regulated and offers safety tips for consumers. Recalls and Safety Alerts: Cellcept and Myfortic Linked to Birth Defects and Fetal Loss Recalls and Safety Alerts: Cellcept and Myfortic Linked to Birth Defects and Fetal Loss
FDA is advising healthcare professionals about an increased risk of fetal harm when women become pregnant while being treated with the immunosuppressant drugs Cellcept (mycophenolate mofetil) or Myfortic (mycophenolic acid). Myfortic is approved t... Levitronix CentriMag Extracorporeal Blood Pumping System: CentriMag Primary Console (with v200 Application Software) Physicians warned not to use Blood Pumping System with Valleylab Force FX-C or SSE2L electrosurgery devices because use may result in stoppage of the pump and may cause serious injury or death. Vyteris Announces Launch of Initiative to Pursue Joint Development - MSN MoneyCentral Vyteris Announces Launch of Initiative to Pursue Joint Development - MSN MoneyCentral
Vyteris, Inc . (OTC BB : VYTR), manufacturer of the first U.S. Food and Drug Administration (FDA)-approved active patch transdermal drug delivery system, announced an initiative to identify and target candidate drugs in the pain management field that Source: news.moneycentral.msn.com Pharmasset drug passes early-stage goal - CNN Money NEW YORK (Associated Press) - Pharmasset Inc. said Tuesday its hepatitis C treatment candidate met safety goals in part of an early-stage study. The drug candidate, called R7128, was administered to patients over a four-week period in 1,000-milligram Source: money.cnn.com FDA strengthens policy on vetting of advisers - San Francisco Gate del.icio.us The Food and Drug Administration said Monday that it will look more closely at conflicts of interest when screening potential members of the influential expert committees that advise the agency on the approval of drugs. Appointments to Source: www.sfgate.com Bayer sues Sandoz over oral contraceptive drug - Reuters FRANKFURT, Aug 5 (Reuters) - Bayer (BAYG.DE: Quote , Profile , Research , Stock Buzz ) has filed a patent infringement lawsuit against Sandoz, a unit of Novartis (NOVN.VX: Quote , Profile , Research , Stock Buzz ) that sought U.S. Food and Drug Source: www.reuters.com Recalls and Safety Alerts: Possible Association between TNF Blockers and Cancer Recalls and Safety Alerts: Possible Association between TNF Blockers and Cancer
FDA has informed healthcare professionals that it is investigating a possible association between drugs that block tumor necrosis factor (TNF) and the development of lymphoma and other cancers in children and young adults. This is part of FDA's ... Federal Authorities Seize Xiadafil VIP Tablets After Company Refuses to Recall Product (July 24) At the request of the U.S. Food and Drug Administration, U.S. Marshals seized nearly $74,000 worth of Xiadafil VIP tablets, Lots 6K029 and 6K209-SEI, distributed by SEI Pharmaceuticals, Inc. of Miami, Fla. Although marketed as a dietary supplement to treat erectile dysfunction (ED) and for sexual enhancement, these lots represent an illegally marketed drug containing an undeclared ingredient. FDA Consumer Corner: Nonoxynol 9 Contraceptives: No Protection against HIV and Other STDs The Food and Drug Administration wants to be sure that consumers know about new warnings on over-the-counter vaginal contraceptive products that contain the spermicide ingredient nonoxynol 9 (N9). These products include spermicidal gels, foams, film... Sage Products Inc. Issues Voluntary Recall of 2% Chlorhexidine Gluconate Cloth Patient Preoperative Skin Preparation (June 27) As a precautionary measure, Sage Products announced a voluntary recall of limited lots of 2 Percent Chlorhexidine Gluconate (CHG) Cloth Patient Preoperative Skin Preparation product. Testing of bulk 2 Percent CHG solution from an outside supplier was found positive for Burkholderia cepacia (B. cepacia). Agricola Zaragoza, Inc. Recalls Jalapeno Peppers Because of Possible Health Risk (July 21) The recall is a result of sampling by FDA, which revealed that these Jalapeno Peppers were contaminated with the same strain of Salmonella Saintpaul responsible for the current Salmonella outbreak. It is unknown at this time which, if any, of the more than 1,200 illnesses reported to date are related to this particular product or to the grower who supplied this product. Distribution of these products has been suspended while FDA, the Texas Department of State Health Services and the company continue their investigation as to the source of the problem. FDA Extends Consumer Warning on Serrano Peppers from Mexico Laboratory testing by the U.S. Food and Drug Administration has confirmed that both a sample of serrano pepper and a sample of irrigation water collected by agency investigators on a farm in the state of Nuevo Leon, Mexico, contain Salmonella Saintpaul with the same genetic fingerprint as the strain of bacteria that is causing the current outbreak in the United States. Recalls and Safety Alerts: Cellcept and Myfortic Linked to Birth Defects and Fetal Loss FDA is advising healthcare professionals about an increased risk of fetal harm when women become pregnant while being treated with the immunosuppressant drugs Cellcept (mycophenolate mofetil) or Myfortic (mycophenolic acid). Myfortic is approved t... C.F. Sauer Foods Issues Allergy Alert on Undeclared Milk in one lot of Gold Medal Spaghetti Sauce Mix (August 4) CF Sauer Foods Inc, of Richmond, VA is recalling all packages of Gold Medal Spaghetti Sauce Mix with the code date as follows: 8119R. People who have an allergy or severe sensitivity to milkrun the risk of serious or life threatening allergic reaction if they consume these products. Publix Issues Recall for No Sugar Added Cherry Pie (July 24) Publix Super Markets is issuing a voluntary recall on three codes of No Sugar Added Cherry Pie with a sell-by-date of July 8 – July 27. UPC numbers for the affected product may be found on the back label below the Nutritional Facts panel: Publix NSA 8inch Cherry Pie, UPC: 41415-65990; Publix NSA 1/2 Cherry Pie, UPC: 03000-00225; and Publix NSA 1/4 Cherry Pie, UPC: 41415-66990. Bay Valley Foods Issues Allergy Alert on Undeclared Milk in Mislabeled Kroger Chicken Noodle Soup (June 24) The recalled product, Kroger Chicken Noodle Soup, comes in 10.5 ounce cans and is marked with lot code 52104098, and a "best before" date code of 40910 (April 9, 2010) that can be found on the bottom of the can. Consumers are urged to return the product to the store where it was purchased for a full refund. FDA gets stricter on conflicts of interest - Marketplace.publicradio.org FDA gets stricter on conflicts of interest - Marketplace.publicradio.org
Stacey Vanek-Smith: Yesterday, the Food and Drug Administration finalized stricter rules for doctors who advise the agency and have financial ties to pharmaceutical companies. The FDA wants to prevent conflicts of interest. Now Congress wants to make Source: marketplace.publicradio.org FDA OKs Flu Vaccines for 2008-09 Season - Washington Post Resize TUESDAY, Aug. 5 (HealthDay News) -- With the memory of last season's flu vaccine mismatch still fresh, U.S. health officials announced Tuesday that they have approved vaccines for the 2008-09 season that include new strains of the virus most Source: www.washingtonpost.com Understanding the definition of a validated software system will help - PR Inside There is one easy answer: you decide what validation is. That is right, the choice is up to you. You and your company have to define/interpret how it will meet the compliance standards set out by the FDA. You and your company have to decide how you Source: www.pr-inside.com Flu vaccines to protect against 3 strains - MSNBC WASHINGTON - U.S. health regulators have approved six versions of the influenza vaccine to help combat the virus during the 2008-2009 flu season later this year. The vaccines include GlaxoSmithKline Plc's Fluarix and FluLaval; Novartis AG's Fluvirin Source: www.msnbc.msn.com The FDA approves 2008-09 flu vaccine - Political Gateway WASHINGTON, Aug. 5 (UPI) -- The U.S. Food and Drug Administration has approved the 2008-09 seasonal influenza vaccine that includes strains likely to cause flu in the United States. The six vaccines and their manufacturers are: CSL Limited, Afluria Source: www.politicalgateway.com U.S. approves 6 flu vaccines for next season - Reuters WASHINGTON (Reuters) - U.S. health regulators have approved six versions of the influenza vaccine to help combat the virus during the 2008-2009 flu season later this year. The vaccines include GlaxoSmithKline Plc's Fluarix and FluLaval; Novartis AG's Source: www.reuters.com FDA advisers must abide by new financial limits - Forbes Outside experts may not participate in federal advisory committee meetings on drugs and medical devices if they have more than a $50,000 financial interest in the companies governed by their decisions, according to new guidelines released Monday. The Source: www.forbes.com The Medicines Company's Cleviprex(TM) Receives FDA Approval - PR Inside themedicinescompany.com - WeissComm Partners Barri Winiarski, 212-301-7209 bwiniarski@wcpglobal.com or The Medicines Company Robyn Brown, 973-656-1616 investor.relations@themedco.com The Medicines Company (NASDAQ: MDCO) announced today that the U.S Source: www.pr-inside.com Revamped Flu Vaccines Approved by FDA - WebMD The FDA today announced that it has approved six flu vaccines after taking the "unusual" step of changing all three flu strains in each of those vaccines. That's what an FDA advisory panel recommended in February after last year's flu vaccine didn't Source: www.webmd.com FDA Advisers Face New U.S. Rules on Industry Ties (Update1) - Bloomberg Aug. 4 (Bloomberg) -- The U.S. Food and Drug Administration won't include outside specialists on its advisory panels if they have a personal financial stake of more than $50,000 in a company affected by a matter under discussion, the agency said. The Source: www.bloomberg.com August 5, 2008Vyteris Announces Launch of Initiative to Pursue Joint Development - MSN MoneyCentral Vyteris Announces Launch of Initiative to Pursue Joint Development - MSN MoneyCentral
Vyteris, Inc . (OTC BB : VYTR), manufacturer of the first U.S. Food and Drug Administration (FDA)-approved active patch transdermal drug delivery system, announced an initiative to identify and target candidate drugs in the pain management field that Source: news.moneycentral.msn.com FDA announces new advisory panel policies - United Press International WASHINGTON, Aug. 4 (UPI) -- The U.S. Food and Drug Administration on Monday announced several updated policies and procedures designed to improve management of its advisory committees. The FDA said the changes include stricter limits on financial Source: www.upi.com Bayer sues Sandoz over oral contraceptive drug - Reuters FRANKFURT, Aug 5 (Reuters) - Bayer (BAYG.DE: Quote , Profile , Research , Stock Buzz ) has filed a patent infringement lawsuit against Sandoz, a unit of Novartis (NOVN.VX: Quote , Profile , Research , Stock Buzz ) that sought U.S. Food and Drug Source: www.reuters.com Tomato Industry Seeing Red - Washington Post While throwing a few rotten tomatoes at U.S. regulators might help ease growers' pain, those involved in the latest salmonella epidemic would prefer cash for their trouble. After weeks of implicating domestic tomatoes in an outbreak of Salmonella Source: www.washingtonpost.com Medicines Co. Blood Pressure Drug Cleviprex Receives FDA’s Approval - Eflux Media The Food and Drug Administration has approved the injectable drug Cleviprex for patients with difficult-to-treat high blood pressure and for those who cannot take oral medications. Cleviprex is the first non-pill drug to receive approval for high Source: www.efluxmedia.com Tomato Growers Seek Payback on Salmonella Scare: Cindy Skrzycki - Bloomberg Aug. 5 (Bloomberg) -- While throwing a few rotten tomatoes at U.S. regulators might help ease their economic pain, growers involved in the latest salmonella food epidemic would prefer cash for their trouble. After weeks of implicating domestic Source: www.bloomberg.com Recalls and Safety Alerts: Possible Association between TNF Blockers and Cancer Recalls and Safety Alerts: Possible Association between TNF Blockers and Cancer
FDA has informed healthcare professionals that it is investigating a possible association between drugs that block tumor necrosis factor (TNF) and the development of lymphoma and other cancers in children and young adults. This is part of FDA's ... FDA advisers must abide by new financial limits - Forbes FDA advisers must abide by new financial limits - Forbes
Outside experts may not participate in federal advisory committee meetings on drugs and medical devices if they have more than a $50,000 financial interest in the companies governed by their decisions, according to new guidelines released Monday. The Source: www.forbes.com Acorda 2Q loss grows on selling and research costs - Forbes Acorda 2Q loss grows on selling and research costs - Forbes
Acorda Therapeutics Inc. said Tuesday its second-quarter loss more than doubled as it conducted a trial of a multiple sclerosis drug candidate, and stepped up sales efforts for its muscle relaxant Zanaflex. The biotechnology company reported positive Source: www.forbes.com Bayer sues Sandoz over oral contraceptive drug - Reuters FRANKFURT, Aug 5 (Reuters) - Bayer (BAYG.DE: Quote , Profile , Research , Stock Buzz ) has filed a patent infringement lawsuit against Sandoz, a unit of Novartis (NOVN.VX: Quote , Profile , Research , Stock Buzz ) that sought U.S. Food and Drug Source: www.reuters.com FDA strengthens policy on vetting of advisers - San Francisco Gate del.icio.us The Food and Drug Administration said Monday that it will look more closely at conflicts of interest when screening potential members of the influential expert committees that advise the agency on the approval of drugs. Appointments to Source: www.sfgate.com FDA Gives Approval to Blood Pressure Drug From Medicines Co. - dbtechno.com Washington (dbTechno) - Medicines Co. has received FDA approval to market their blood pressure drug, Cleviprex. The U.S. Food and Drug Administration (FDA) approved the blood pressure drug, which has been highly touted as something which could help Source: www.dbtechno.com Medicines Co. Blood Pressure Drug Cleviprex Receives FDA’s Approval - Eflux Media The Food and Drug Administration has approved the injectable drug Cleviprex for patients with difficult-to-treat high blood pressure and for those who cannot take oral medications. Cleviprex is the first non-pill drug to receive approval for high Source: www.efluxmedia.com FDA announces new advisory panel policies - United Press International WASHINGTON, Aug. 4 (UPI) -- The U.S. Food and Drug Administration on Monday announced several updated policies and procedures designed to improve management of its advisory committees. The FDA said the changes include stricter limits on financial Source: www.upi.com Levitronix CentriMag Extracorporeal Blood Pumping System: CentriMag Primary Console (with v200 Application Software) Levitronix CentriMag Extracorporeal Blood Pumping System: CentriMag Primary Console (with v200 Application Software)
Physicians warned not to use Blood Pumping System with Valleylab Force FX-C or SSE2L electrosurgery devices because use may result in stoppage of the pump and may cause serious injury or death. Strengthening the Advisory Committee Process FDA is strengthening the process by which it gets expert, independent advice that affects new treatments and other products available to consumers. Mitoxantrone Hydrochloride (marketed as Novantrone and generics) Post-marketing safety study shows poor adherence to cardiac monitoring recommendations in clinical practice. FDA is working with the manufacturers to educate healthcare providers to adhere to recommendations for patients with MS. Erythropoiesis Stimulating Agents (ESAs) - Epoetin alfa (marketed as Procrit, Epogen), Darbepoetin alfa (marketed as Aranesp) FDA clarifies approved conditions for use of ESAs in patients with cancer and revises dosing directions for the products. Preventing Medical Errors: Danger Giving Topical Thrombin Intravascularly The Institute for Safe Medication Practices (ISMP) recently warned about the dangers of accidentally giving topical thrombin intravascularly. Thrombin applied topically can help stop oozing blood and minor bleeding from capillaries and small veins. ... FDA 101: Biological Products Basic facts about biologics, products that replicate natural biologic substances such as enzymes, antibodies, or hormones in our bodies. June 2008 Monthly Safety Labeling Summary of safety-related revisions to the BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, and ADVERSE REACTIONS sections of the Prescribing Information, plus Patient Package Inserts and Medication Guides. Vyteris Announces Launch of Initiative to Pursue Joint Development - MSN MoneyCentral Vyteris Announces Launch of Initiative to Pursue Joint Development - MSN MoneyCentral
Vyteris, Inc . (OTC BB : VYTR), manufacturer of the first U.S. Food and Drug Administration (FDA)-approved active patch transdermal drug delivery system, announced an initiative to identify and target candidate drugs in the pain management field that Source: news.moneycentral.msn.com Bayer sues Sandoz over oral contraceptive drug - Reuters FRANKFURT, Aug 5 (Reuters) - Bayer (BAYG.DE: Quote , Profile , Research , Stock Buzz ) has filed a patent infringement lawsuit against Sandoz, a unit of Novartis (NOVN.VX: Quote , Profile , Research , Stock Buzz ) that sought U.S. Food and Drug Source: www.reuters.com Medicines Co. Blood Pressure Drug Cleviprex Receives FDA’s Approval - Eflux Media The Food and Drug Administration has approved the injectable drug Cleviprex for patients with difficult-to-treat high blood pressure and for those who cannot take oral medications. Cleviprex is the first non-pill drug to receive approval for high Source: www.efluxmedia.com August 2008 Patient Safety News August 2008 Patient Safety News
Video news show for healthcare professionals, covering safety alerts, recalls, product approvals, and important tips on protecting patients. Micro-bubble Contrast Agents (marketed as Definity (Perflutren Lipid Microsphere) Injectable Suspension and Optison (Perflutren Protein-Type A Microspheres for Injection) Changes to the Boxed Warning, Warnings, and Contraindications sections of the prescribing information to reflect conclusions of FDA reviews of information received following the addition of new contraindications and warnings in October 2007. Are You Storing Food Safely? When, where, and how you store food can help prevent foodborne illnesses. Here are pointers for safely storing food in your refrigerator, freezer, and cupboards. Levitronix CentriMag Extracorporeal Blood Pumping System: CentriMag Primary Console (with v200 Application Software) Physicians warned not to use Blood Pumping System with Valleylab Force FX-C or SSE2L electrosurgery devices because use may result in stoppage of the pump and may cause serious injury or death. Mitoxantrone Hydrochloride (marketed as Novantrone and generics) Post-marketing safety study shows poor adherence to cardiac monitoring recommendations in clinical practice. FDA is working with the manufacturers to educate healthcare providers to adhere to recommendations for patients with MS. June 2008 Monthly Safety Labeling Summary of safety-related revisions to the BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, and ADVERSE REACTIONS sections of the Prescribing Information, plus Patient Package Inserts and Medication Guides. Federal Agents Seize more than $24 Million in Unapproved New Drugs Representatives of the U.S. Food and Drug Administration and the U.S. Marshals Service today seized $24.2 million worth of unapproved new drugs from KV Pharmaceutical Company of St. Louis, Mo. Agents acted after United States Attorney Catherine L. Hanaway filed a civil forfeiture suit and obtained a warrant to seize the unapproved new drug products being made by KV Pharmaceutical. Abacavir (marketed as Ziagen) and Abacavir-containing Medications Association between HLA-B*5701 allele and hypersensitivity reactions identified and patient screening for the allele recommended before starting or restarting treatment. Viapro 375mg Capsules Product recalled because it was found to contain a potentially harmful analog of Sildenafil. Boehringer says Aptivus HIV drug shows long-term efficacy in children - Forbes Boehringer says Aptivus HIV drug shows long-term efficacy in children - Forbes
INGELHEIM AM RHEIN, Germany (Thomson Financial) - Boehringer Ingelheim GmbH. said its Aptivus anti-virus drug was shown to be effective and safe for HIV infected children and adolescents in a two-year study involving 78 patients who previously Source: www.forbes.com The Medicines Company's Cleviprex(TM) Receives FDA Approval - MSN MoneyCentral The Medicines Company MDCO announced today that the U.S. Food and Drug Administration (FDA) has approved the intravenous (IV) therapy Cleviprex TM (clevidipine butyrate) injectable emulsion for the reduction of blood pressure when oral therapy is not Source: news.moneycentral.msn.com FDA unexpectedly rejects Schering anesthesia drug - Boston Globe NEW YORK (Reuters) - Schering-Plough Corp said Source: www.boston.com More soy, less sperm? New study in the journal Human Reproduction - Los Angeles Times In the wake of the recent study linking soy to reduced sperm concentration in men, newspaper and Internet headlines proclaimed the health food a cause of male infertility. It's true that the study was the largest so far to examine soy's effects on Source: www.latimes.com For leg-cramp sufferers, there's no good alternatives to quinine - Los Angeles Times I am devastated that quinine is no longer available. I have taken it safely for decades to reduce leg cramping. Many people do well with quinine, but for some it is extremely dangerous. One reader wrote: "I took quinine for nighttime leg cramps Source: www.latimes.com Abbott faces more litigation over AIDS drug - Lompoc Record SAN FRANCISCO - When Abbott Laboratories Inc. hiked up the price of a popular AIDS drug by 400 percent in 2003, executives prepared for the inevitable public relations hit, but assured themselves the backlash would be brief. Nearly five years later Source: www.lompocrecord.com More AIDS drug suits dog Abbott - Chicago Tribune SAN FRANCISCO — When Abbott Laboratories raised the price of a popular AIDS drug by 400 percent in 2003, executives prepared for the inevitable public relations hit but assured themselves the backlash would be brief. Nearly five years later, the Source: www.chicagotribune.com Politicians note: Drug reimportation is waning - Buffalo News With campaign season heating up, more and more lawmakers, on both sides of the aisle, are promising to promote prescription drug reimportation if elected. Advocates claim that such action would drive down the nation’s escalating health care costs Source: www.buffalonews.com Single-Pill Combinations Diovan HCT and Exforge Approved in US as - MSN MoneyCentral EAST HANOVER, N.J. , Aug. 4 /PRNewswire/ -- The US Food and Drug Administration (FDA) has approved two single-pill combination medications, Diovan HCT(R) (valsartan and hydrochlorothiazide) and Exforge(R) (amlodipine and valsartan), as initial or Source: news.moneycentral.msn.com FDA announces new advisory panel policies - United Press International WASHINGTON, Aug. 4 (UPI) -- The U.S. Food and Drug Administration on Monday announced several updated policies and procedures designed to improve management of its advisory committees. The FDA said the changes include stricter limits on financial Source: www.upi.com Abacavir (marketed as Ziagen) and Abacavir-containing Medications Abacavir (marketed as Ziagen) and Abacavir-containing Medications
Association between HLA-B*5701 allele and hypersensitivity reactions identified and patient screening for the allele recommended before starting or restarting treatment. Levitronix CentriMag Extracorporeal Blood Pumping System: CentriMag Primary Console (with v200 Application Software) Physicians warned not to use Blood Pumping System with Valleylab Force FX-C or SSE2L electrosurgery devices because use may result in stoppage of the pump and may cause serious injury or death. Sodium Polystyrene Sulfonate Suspension Recall of 2 lots of the product due to the presence of yeast which could affect patients who are immunocompromised. Salmolux Inc. Recalls Wild Alaskan Smoked Salmon Nova Lox Lot # 01418 Because of Possible Health Risk (July 9) Salmolux Inc. of Federal Way, WA, is recalling lot # 01418 of its Wild Alaskan Smoked Salmon Nova Lox sold in 3 ounce packages due to the potential to be contaminated with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Vita Food Products Issues Alert Regarding Vita Nova Salmon (July 25) The product that is the subject of this public announcement and recall are packages (deep dark blue in color) of smoked salmon that bear the Vita logo in the upper left corner on the part of the packaging that is immediately visible to the consumer. Each package contains 4-10 bacon-style slices (total 3 oz.) of smoked salmon; the slices are contained in a vacuum pack within a box that is 4" wide by 7.5" in length by 1/2" in thickness. IMPORTANT: The Code Date of 11/16/08 198 is on the left end flap of each package. This announcement and recall only applies to packages that bear that CODE DATE. June 2008 Monthly Safety Labeling Summary of safety-related revisions to the BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, and ADVERSE REACTIONS sections of the Prescribing Information, plus Patient Package Inserts and Medication Guides. Viapro 375mg Capsules Product recalled because it was found to contain a potentially harmful analog of Sildenafil. Micro-bubble Contrast Agents (marketed as Definity (Perflutren Lipid Microsphere) Injectable Suspension and Optison (Perflutren Protein-Type A Microspheres for Injection) Changes to the Boxed Warning, Warnings, and Contraindications sections of the prescribing information to reflect conclusions of FDA reviews of information received following the addition of new contraindications and warnings in October 2007. Giant Food Alerts Customers to Voluntary Recall of Giant Brand Garlic Bread and Garlic Spread (June 27) Giant Food has announced a voluntary recall of Giant brand garlic bread and garlic spread products sold in its Bakeshop as the items contain milk products which are not declared on the labels. Giant removed from its shelves all 16 ounce packages of Giant brand garlic bread and all 16 ounce packages of Giant brand garlic spread products. Current Drug Shortage: Proglycem (diazoxide) oral suspension Current Drug Shortage: Proglycem (diazoxide) oral suspension
Teva is managing inventory and can provide product from their emergency supply. Orders for Proglycem can be made during regular business hours (8am to 5pm Eastern, Monday through Friday) by calling Customer Service at 800-545-8800. Emergency requests can be made after hours by calling 800-795-2652 Recalls and Safety Alerts: Cellcept and Myfortic Linked to Birth Defects and Fetal Loss Recalls and Safety Alerts: Cellcept and Myfortic Linked to Birth Defects and Fetal Loss
FDA is advising healthcare professionals about an increased risk of fetal harm when women become pregnant while being treated with the immunosuppressant drugs Cellcept (mycophenolate mofetil) or Myfortic (mycophenolic acid). Myfortic is approved t... Recalls and Safety Alerts: Possible Association between TNF Blockers and Cancer FDA has informed healthcare professionals that it is investigating a possible association between drugs that block tumor necrosis factor (TNF) and the development of lymphoma and other cancers in children and young adults. This is part of FDA's ... August 4, 2008For leg-cramp sufferers, there's no good alternatives to quinine - Los Angeles Times For leg-cramp sufferers, there's no good alternatives to quinine - Los Angeles Times
I am devastated that quinine is no longer available. I have taken it safely for decades to reduce leg cramping. Many people do well with quinine, but for some it is extremely dangerous. One reader wrote: "I took quinine for nighttime leg cramps Source: www.latimes.com FDA unexpectedly rejects Schering anesthesia drug - Boston Globe NEW YORK (Reuters) - Schering-Plough Corp said Source: www.boston.com Politicians note: Drug reimportation is waning - Buffalo News With campaign season heating up, more and more lawmakers, on both sides of the aisle, are promising to promote prescription drug reimportation if elected. Advocates claim that such action would drive down the nation’s escalating health care costs Source: www.buffalonews.com Abbott faces more litigation over AIDS drug - Lompoc Record SAN FRANCISCO - When Abbott Laboratories Inc. hiked up the price of a popular AIDS drug by 400 percent in 2003, executives prepared for the inevitable public relations hit, but assured themselves the backlash would be brief. Nearly five years later Source: www.lompocrecord.com Single-Pill Combinations Diovan HCT and Exforge Approved in US as - MSN MoneyCentral EAST HANOVER, N.J. , Aug. 4 /PRNewswire/ -- The US Food and Drug Administration (FDA) has approved two single-pill combination medications, Diovan HCT(R) (valsartan and hydrochlorothiazide) and Exforge(R) (amlodipine and valsartan), as initial or Source: news.moneycentral.msn.com June 2008 Monthly Safety Labeling June 2008 Monthly Safety Labeling
Summary of safety-related revisions to the BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, and ADVERSE REACTIONS sections of the Prescribing Information, plus Patient Package Inserts and Medication Guides. Recalls and Safety Alerts: Possible Association between TNF Blockers and Cancer FDA has informed healthcare professionals that it is investigating a possible association between drugs that block tumor necrosis factor (TNF) and the development of lymphoma and other cancers in children and young adults. This is part of FDA's ... Abacavir (marketed as Ziagen) and Abacavir-containing Medications Association between HLA-B*5701 allele and hypersensitivity reactions identified and patient screening for the allele recommended before starting or restarting treatment. Electronic Medical Devices Possible malfunction of Electronic Medical Devices caused by Computed Tomography (CT) Scanning on patients with implanted and external electronic medical devices. Recalls and Safety Alerts: Warning Added to Regranex Label A boxed warning alerting healthcare professionals to an increased risk of cancer death has been added to the labeling for Regranex (becaplermin), a topical medication used to treat certain diabetic foot and leg ulcers. Based on a review of an ea... Vita Food Products Issues Alert Regarding Vita Nova Salmon (July 25) The product that is the subject of this public announcement and recall are packages (deep dark blue in color) of smoked salmon that bear the Vita logo in the upper left corner on the part of the packaging that is immediately visible to the consumer. Each package contains 4-10 bacon-style slices (total 3 oz.) of smoked salmon; the slices are contained in a vacuum pack within a box that is 4" wide by 7.5" in length by 1/2" in thickness. IMPORTANT: The Code Date of 11/16/08 198 is on the left end flap of each package. This announcement and recall only applies to packages that bear that CODE DATE. Micro-bubble Contrast Agents (marketed as Definity (Perflutren Lipid Microsphere) Injectable Suspension and Optison (Perflutren Protein-Type A Microspheres for Injection) Changes to the Boxed Warning, Warnings, and Contraindications sections of the prescribing information to reflect conclusions of FDA reviews of information received following the addition of new contraindications and warnings in October 2007. EG Labs Announces Urgent Nationwide Voluntary Recall of ALL LOTS of Viapro 375 mg Capsules, due to a Potentially Harmful Ingredient EG Labs, LLC, announced today that it is conducting a nationwide voluntary recall of all lots of its supplement product sold under the brand name, Viapro, in 375mg capsules. EG Labs, LLC. is conducting this recall after being informed by representatives of the Food and Drug Administration (FDA) that lab analysis by FDA of a sample from one lot of the product revealed that it contained a potentially harmful undeclared ingredient, thio-methisosildenafil. Jack Distribution, LLC. Issues a Voluntary Nationwide Recall of Select Lots of Rize 2 The Occasion Capsules and Rose 4 Her Capsules (July 1) Jack Distribution, LLC, and its wholesale distributors G and N Works, Inc., and Devine Distribution, Inc., announced today that they are conducting a voluntary nationwide recall of the following lot numbers of the company's supplement products sold under the brand names Rize 2 The Occasion and Rose 4 Her. (Rize 2 lot numbers CG-84 expires 11/10, GD-98 expires 08/10, CC-06 expires 06/10, 709 expires 09/10, CG-79 expires 11/10) (Rose 4 Her lot number CG-78 expires 11/10). Politicians note: Drug reimportation is waning - Buffalo News Politicians note: Drug reimportation is waning - Buffalo News
With campaign season heating up, more and more lawmakers, on both sides of the aisle, are promising to promote prescription drug reimportation if elected. Advocates claim that such action would drive down the nation’s escalating health care costs Source: www.buffalonews.com The Medicines Company's Cleviprex(TM) Receives FDA Approval - MSN MoneyCentral The Medicines Company MDCO announced today that the U.S. Food and Drug Administration (FDA) has approved the intravenous (IV) therapy Cleviprex TM (clevidipine butyrate) injectable emulsion for the reduction of blood pressure when oral therapy is not Source: news.moneycentral.msn.com Boehringer says Aptivus HIV drug shows long-term efficacy in children - Forbes INGELHEIM AM RHEIN, Germany (Thomson Financial) - Boehringer Ingelheim GmbH. said its Aptivus anti-virus drug was shown to be effective and safe for HIV infected children and adolescents in a two-year study involving 78 patients who previously Source: www.forbes.com More AIDS drug suits dog Abbott - Chicago Tribune SAN FRANCISCO — When Abbott Laboratories raised the price of a popular AIDS drug by 400 percent in 2003, executives prepared for the inevitable public relations hit but assured themselves the backlash would be brief. Nearly five years later, the Source: www.chicagotribune.com For leg-cramp sufferers, there's no good alternatives to quinine - Los Angeles Times I am devastated that quinine is no longer available. I have taken it safely for decades to reduce leg cramping. Many people do well with quinine, but for some it is extremely dangerous. One reader wrote: "I took quinine for nighttime leg cramps Source: www.latimes.com Are You Storing Food Safely? Are You Storing Food Safely?
When, where, and how you store food can help prevent foodborne illnesses. Here are pointers for safely storing food in your refrigerator, freezer, and cupboards. Abacavir (marketed as Ziagen) and Abacavir-containing Medications Association between HLA-B*5701 allele and hypersensitivity reactions identified and patient screening for the allele recommended before starting or restarting treatment. Jack Distribution, LLC. Issues a Voluntary Nationwide Recall of all Lots of Rize 2 The Occasion Capsules and Rose 4 Her Capsules, Products Marketed as Dietary Supplements, Containing an Undeclared Ingredient(July 28) Jack Distribution, LLC, and its wholesale distributors G and N works, Inc., and Devine Distribution, Inc., announced today that they are conducting a voluntary nationwide recall of all lot numbers of the company's supplement products sold under the brand names Rize 2 The Occasion and Rose 4 Her. New lots of Rize 2 and Rose 4 her (not subject to this recall) will contain lot numbers beginning in "BL". Agricola Zaragoza, Inc. Recalls Jalapeno Peppers Because of Possible Health Risk (July 21) The recall is a result of sampling by FDA, which revealed that these Jalapeno Peppers were contaminated with the same strain of Salmonella Saintpaul responsible for the current Salmonella outbreak. It is unknown at this time which, if any, of the more than 1,200 illnesses reported to date are related to this particular product or to the grower who supplied this product. Distribution of these products has been suspended while FDA, the Texas Department of State Health Services and the company continue their investigation as to the source of the problem. Jack Distribution, LLC. Issues a Voluntary Nationwide Recall of Select Lots of Rize 2 The Occasion Capsules and Rose 4 Her Capsules (July 1) Jack Distribution, LLC, and its wholesale distributors G and N Works, Inc., and Devine Distribution, Inc., announced today that they are conducting a voluntary nationwide recall of the following lot numbers of the company's supplement products sold under the brand names Rize 2 The Occasion and Rose 4 Her. (Rize 2 lot numbers CG-84 expires 11/10, GD-98 expires 08/10, CC-06 expires 06/10, 709 expires 09/10, CG-79 expires 11/10) (Rose 4 Her lot number CG-78 expires 11/10). Electronic Medical Devices Possible malfunction of Electronic Medical Devices caused by Computed Tomography (CT) Scanning on patients with implanted and external electronic medical devices. FDA Extends Consumer Warning on Serrano Peppers from Mexico Laboratory testing by the U.S. Food and Drug Administration has confirmed that both a sample of serrano pepper and a sample of irrigation water collected by agency investigators on a farm in the state of Nuevo Leon, Mexico, contain Salmonella Saintpaul with the same genetic fingerprint as the strain of bacteria that is causing the current outbreak in the United States. Lucky Green Trading, Inc. Recalls Thai Basil Because of Possible Health Risk (July 9) LUCKY GREEN TRADING, INC. of Garden Grove, CA is recalling Thai Basil , because it has the potential to be contaminated with Salmonella , an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Actavis Totowa Announces Voluntary Recall at the Retail Level of All Drug Products Manufactured at its Little Falls, New Jersey Facility (August 1) Actavis Totowa LLC, a generic drug manufacturer, is announcing a voluntary recall, to the retail level, of all drug products manufactured at its Little Falls, New Jersey facility. This is a precautionary, voluntary action by Actavis following an inspection conducted by the Food and Drug Administration earlier this year. Stronger Warnings Requested for Fluoroquinolones FDA has notified manufacturers of fluoroquinolones that a boxed warning on the increased risk of tendinitis and tendon rupture is necessary. For leg-cramp sufferers, there's no good alternatives to quinine - Los Angeles Times For leg-cramp sufferers, there's no good alternatives to quinine - Los Angeles Times
I am devastated that quinine is no longer available. I have taken it safely for decades to reduce leg cramping. Many people do well with quinine, but for some it is extremely dangerous. One reader wrote: "I took quinine for nighttime leg cramps Source: www.latimes.com Abbott faces more litigation over AIDS drug - Lompoc Record SAN FRANCISCO - When Abbott Laboratories Inc. hiked up the price of a popular AIDS drug by 400 percent in 2003, executives prepared for the inevitable public relations hit, but assured themselves the backlash would be brief. Nearly five years later Source: www.lompocrecord.com Stay Healthy While Traveling Abroad Stay Healthy While Traveling Abroad
Getting sick can ruin your trip. FDA shares the guidance it gives to overseas inspectors to help them remain healthy while traveling abroad. Domega International Co., Ltd. Issues an Alert on Undeclared Sulfites in Korica Brand Mut Gung Sweetened Ginger (July 16) The recalled Korica Brand Mut Gung Sweetened Ginger is sold in uncoded 7 oz plastic tubs and is a product of Vietnam. The product was sold nationwide. Current Drug Shortage: Proglycem (diazoxide) oral suspension Teva is managing inventory and can provide product from their emergency supply. Orders for Proglycem can be made during regular business hours (8am to 5pm Eastern, Monday through Friday) by calling Customer Service at 800-545-8800. Emergency requests can be made after hours by calling 800-795-2652 Resolved Drug Shortage: Digoxin oral tablets See website for more information about this resolved shortage. August 3, 2008Farmers, lawmakers criticize salmonella response - Miami Herald Farmers, lawmakers criticize salmonella response - Miami Herald
WASHINGTON Turf struggles, bad communication and weak leadership undermined the federal response to a recent salmonella outbreak that cost the tomato industry a bundle, witnesses told a House of Representatives subcommittee Thursday. Lawmakers joined Source: www.miamiherald.com UCB H1 net down 37 pct, cuts 2008 revenue forecast - Guardian Unlimited BRUSSELS, Aug 1 (Reuters) - Belgian pharmaceutical group UCB reported a better-than-expected 37 percent drop in first-half net profit on Friday after a key drug lost patent protection and lowered its full-year revenue forecast. It also announced a Source: www.guardian.co.uk FDA rejects Schering-Plough's anesthesia-reversing drug, citing - Baltimore Sun FDA rejects Schering-Plough's anesthesia-reversing drug, citing - Baltimore Sun
WASHINGTON (AP) _ Government regulators dealt a major setback to Schering-Plough Corp., rejecting a highly anticipated drug designed to help patients recover from anesthesia. The Food and Drug Administration notified the company Thursday that it will Source: www.baltimoresun.com FDA rejects Schering drug to reverse anesthesia - Forbes Government regulators dealt a major setback to Schering-Plough Corp., rejecting a highly anticipated drug designed to help patients recover from anesthesia. The Food and Drug Administration notified the company Thursday that it will not approve its Source: www.forbes.com News - Cutting Edge - CNET News A privately funded rocket suffered a launch failure Saturday night, the third launch failure in as many attempts for an Internet entrepreneur who is hoping to develop private space delivery and transportation. The failure occurred about two minutes Source: news.cnet.com ANALYSIS-US FDA caution seen with Schering drug rejection - Forbes WASHINGTON (Reuters) - The unusual rejection of an experimental drug with unanimous support from outside experts signals further caution by the U.S. Food and Drug Administration and increased uncertainty for investors. The FDA's surprising refusal Source: www.forbes.com 3 partygoers missing after early morning fire destroys house in - Minneapolis Star Tribune Anglican leader urges ban on gay bishops School bully problem? Send in the clown Some see red over proposed 'green' resort in Maine Bikers down to bare basics for eco demonstration Daschle criticizes FBI's handling of anthrax probe LITTLETON, Colo Source: www.startribune.com FDA requests additional study on Pozen drug - Boston Globe CHAPEL HILL, N.C.— Drug developer Pozen Inc. said Friday federal regulators have requested an additional study of its experimental heart treatment before considering it for approval. Shares of Pozen Inc. fell on the news, dropping 46 cents, or 3.8 Source: www.boston.com CORRECTED:House asks FDA to turn over Vytorin study analysis:WSJ - Reuters UK NEW YORK (Reuters) - The House Energy and Commerce committee wants the U.S. Food and Drug Administration to turn over the results of an analysis about the potential links between cancer and cholesterol drug Vytorin, the Wall Street Journal reported Source: uk.reuters.com Senators prod FDA to raise standards on sunscreen - CNN Money NEW YORK (Associated Press) - A pair of powerful Democratic senators are prodding the Food and Drug Administration to release tougher standards for sunscreen labels that have been in the works for 30 years. A bill introduced Friday by Sens Source: money.cnn.com Nixing Grassley's delegate status was a poor decision - Dubuque Telegraph Herald Gentleman that he is, Sen. Chuck Grassley is quietly accepting the Iowa Republican Party's decision to omit him from the list of delegates to its national convention. Asked if he would be going to the convention, Grassley told Iowa reporters he would Source: www.thonline.com Nixing Grassley's delegate status was a poor decision - Dubuque Telegraph Herald Nixing Grassley's delegate status was a poor decision - Dubuque Telegraph Herald
Gentleman that he is, Sen. Chuck Grassley is quietly accepting the Iowa Republican Party's decision to omit him from the list of delegates to its national convention. Asked if he would be going to the convention, Grassley told Iowa reporters he would Source: www.thonline.com ANALYSIS-US FDA caution seen with Schering drug rejection - Forbes WASHINGTON (Reuters) - The unusual rejection of an experimental drug with unanimous support from outside experts signals further caution by the U.S. Food and Drug Administration and increased uncertainty for investors. The FDA's surprising refusal Source: www.forbes.com Senators prod FDA to raise standards on sunscreen - CNN Money NEW YORK (Associated Press) - A pair of powerful Democratic senators are prodding the Food and Drug Administration to release tougher standards for sunscreen labels that have been in the works for 30 years. A bill introduced Friday by Sens Source: money.cnn.com Senators prod FDA to toughen standards on sunscreen labels - Maryland Daily Record Two powerful Democratic senators are prodding the Food and Drug Administration to release tougher standards for sunscreen labels that have been in the works for 30 years. A bill introduced Friday by Sens. Christopher Dodd and Jack Reed would force Source: www.mddailyrecord.com FDA rejects Schering-Plough's anesthesia-reversing drug, citing - Baltimore Sun WASHINGTON (AP) _ Government regulators dealt a major setback to Schering-Plough Corp., rejecting a highly anticipated drug designed to help patients recover from anesthesia. The Food and Drug Administration notified the company Thursday that it will Source: www.baltimoresun.com FDA rejects Schering drug to reverse anesthesia - Forbes Government regulators dealt a major setback to Schering-Plough Corp., rejecting a highly anticipated drug designed to help patients recover from anesthesia. The Food and Drug Administration notified the company Thursday that it will not approve its Source: www.forbes.com CORRECTED:House asks FDA to turn over Vytorin study analysis:WSJ - Reuters UK NEW YORK (Reuters) - The House Energy and Commerce committee wants the U.S. Food and Drug Administration to turn over the results of an analysis about the potential links between cancer and cholesterol drug Vytorin, the Wall Street Journal reported Source: uk.reuters.com FDA requests additional study on Pozen drug - Boston Globe CHAPEL HILL, N.C.— Drug developer Pozen Inc. said Friday federal regulators have requested an additional study of its experimental heart treatment before considering it for approval. Shares of Pozen Inc. fell on the news, dropping 46 cents, or 3.8 Source: www.boston.com 3 partygoers missing after early morning fire destroys house in - Minneapolis Star Tribune Anglican leader urges ban on gay bishops School bully problem? Send in the clown Some see red over proposed 'green' resort in Maine Bikers down to bare basics for eco demonstration Daschle criticizes FBI's handling of anthrax probe LITTLETON, Colo Source: www.startribune.com FDA Reaches Settlement with California Hearing Device Maker FDA Reaches Settlement with California Hearing Device Maker
The U.S. Food and Drug Administration (FDA) has reached a settlement with California hearing device manufacturer Advanced Bionics LLC and its president and CEO Jeffrey Greiner over alleged violations of federal law. Erythropoiesis Stimulating Agents (ESAs) - Epoetin alfa (marketed as Procrit, Epogen), Darbepoetin alfa (marketed as Aranesp) FDA clarifies approved conditions for use of ESAs in patients with cancer and revises dosing directions for the products. Federal Authorities Seize Xiadafil VIP Tablets After Company Refuses to Recall Product At the request of the U.S. Food and Drug Administration, U.S. Marshals seized nearly $74,000 worth of Xiadafil VIP tablets, Lots 6K029 and 6K209-SEI, distributed by SEI Pharmaceuticals, Inc. of Miami, Fla. Although marketed as a dietary supplement to treat erectile dysfunction (ED) and for sexual enhancement, these lots represent an illegally marketed drug containing an undeclared ingredient. Levitronix CentriMag Extracorporeal Blood Pumping System: CentriMag Primary Console (with v200 Application Software) Physicians warned not to use Blood Pumping System with Valleylab Force FX-C or SSE2L electrosurgery devices because use may result in stoppage of the pump and may cause serious injury or death. Resolved Drug Shortage: Digoxin oral tablets Resolved Drug Shortage: Digoxin oral tablets
See website for more information about this resolved shortage. FDA 101: Biological Products Basic facts about biologics, products that replicate natural biologic substances such as enzymes, antibodies, or hormones in our bodies. Beware of Bug Bites and Stings Beware of Bug Bites and Stings
Ticks, mosquitoes, and bees--here are tips for preventing and treating bug bites and stings. Warning for Regranex—Cream for Leg and Foot Ulcers A boxed warning has been added to the label of Regranex Gel 0.01% (becaplermin) to address the increased risk of cancer death in patients who use three or more tubes of the product. Bay Valley Foods Issues Allergy Alert on Undeclared Milk in Mislabeled Kroger Chicken Noodle Soup (June 24) The recalled product, Kroger Chicken Noodle Soup, comes in 10.5 ounce cans and is marked with lot code 52104098, and a "best before" date code of 40910 (April 9, 2010) that can be found on the bottom of the can. Consumers are urged to return the product to the store where it was purchased for a full refund. Salmolux Inc. Recalls Wild Alaskan Smoked Salmon Nova Lox Lot # 01418 Because of Possible Health Risk (July 9) Salmolux Inc. of Federal Way, WA, is recalling lot # 01418 of its Wild Alaskan Smoked Salmon Nova Lox sold in 3 ounce packages due to the potential to be contaminated with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. FDA unexpectedly rejects Schering anesthesia drug - Forbes FDA unexpectedly rejects Schering anesthesia drug - Forbes
NEW YORK (Reuters) - Schering-Plough Corp (nyse: SGP - news - people ) said Friday U.S. regulators had rejected Bridion, its drug to reverse the effects of anesthesia that had been heralded as a breakthrough product by analysts and was unanimously Source: www.forbes.com EG Labs Announces Urgent Nationwide Voluntary Recall of ALL LOTS of Viapro 375 mg Capsules, due to a Potentially Harmful Ingredient EG Labs Announces Urgent Nationwide Voluntary Recall of ALL LOTS of Viapro 375 mg Capsules, due to a Potentially Harmful Ingredient
EG Labs, LLC, announced today that it is conducting a nationwide voluntary recall of all lots of its supplement product sold under the brand name, Viapro, in 375mg capsules. EG Labs, LLC. is conducting this recall after being informed by representatives of the Food and Drug Administration (FDA) that lab analysis by FDA of a sample from one lot of the product revealed that it contained a potentially harmful undeclared ingredient, thio-methisosildenafil. Sau-Sea Foods, Inc. Issues Allergy Alert on Undeclared Egg in Smoked Salmon Spread in 7.5 Ounce Plastic Tub With Snap Lid (July 18) Sau-Sea foods, Inc, of Water Mill NY is recalling all tubs of SMOKED SALMON Spread with the sell by dates as follows: 072308, 082708, 092408, 1 12508, 03 1309. People who have an allergy or severe sensitivity to egg run the risk of serious or life threatening allergic reaction if they consume these products. Lucky Green Trading, Inc. Recalls Thai Basil Because of Possible Health Risk (July 9) LUCKY GREEN TRADING, INC. of Garden Grove, CA is recalling Thai Basil , because it has the potential to be contaminated with Salmonella , an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Warnings on Raw Jalapeño and Serrano Peppers from Mexico Until further notice, FDA is advising consumers to avoid raw serrano peppers from Mexico, in addition to raw jalapeño peppers from Mexico, and any foods that contain them. |
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