FDA NEWS

FDA Approves First Generic Tamsulosin to Treat Enlarged Prostate Gland

noreply@blogger.com (Network) — Wed, 10 Mar 2010 20:30:00 +0000

FDA Approves First Generic Tamsulosin to Treat Enlarged Prostate Gland
The U.S. Food and Drug Administration today approved the first generic version of Flomax Capsules 0.4 mg (tamsulosin hydrochloride) to treat benign prostatic hyperplasia (BPH), a condition in which an enlarged prostate gland causes problems with urination.
Source: www.fda.gov

Exjade (deferasirox): Boxed Warning
Changes to Prescribing Information re: risk of renal impairment/failure, hepatic impairment/failure or gastrointestinal hemorrhage.
Source: www.fda.gov

Warning: Counterfeit Alli

noreply@blogger.com (Network) — Mon, 08 Mar 2010 16:21:00 +0000

Warning: Counterfeit Alli
FDA warns of counterfeit weight-loss drug Alli 60 mg capsules (120 count refill pack) sold over the Internet.
Source: www.fda.gov

Invirase (saquinavir): Ongoing safety review of clinical trial data
Possible association with abnormal heart rhythms when used in combination with Norvir (ritonavir).
Source: www.fda.gov

Survey Shows Gains in Food-Label Use, Health/Diet Awareness
FDA has released findings from its latest Health & Diet Survey, which offers a snapshot of the nation's dietary habits.
Source: www.fda.gov

Videx/Videx EC (didanosine): Labeling Revision - Risk of Non-Cirrhotic Portal Hypertension
Risk information added to Warnings/Precautions section and data summary provided
Source: www.fda.gov

Thomas Medical Products, Inc., Transseptal Sheath Introducer Kits: Class I Recall
Sheath tip may break off and separate during heart procedures, causing a blockage that could lead to permanent injury and/or death.
Source: www.fda.gov

Tysabri (Natalizumab): Update of Healthcare Professional Information
Risk of developing progressive multifocal leukoencephalopathy (PML) increases with increasing duration of exposure to Tysabri.
Source: www.fda.gov

Upcoming Webinar to Inform Public About Access to Investigational Drugs
On Tuesday, Feb. 23, 2010, FDA experts will host an online session and invite questions from the public on accessing investigational, or experimental, drugs.
Source: www.fda.gov

Reporting Problems to FDA (video)
This guide provides tips and a quick-reference chart to help you report a problem to FDA.
Source: www.fda.gov

Indoor Tanning: The Risks of Ultraviolet Rays
There’s no such thing as a safe tan. Whether from the sun or from sunlamps used in tanning equipment, ultraviolet rays pose a health risk.
Source: www.fda.gov

Warning on Body Building Products (video)
In this Consumer Update video, FDA Product Safety Expert Deborah Autor, J.D., helps explain the agency's warning, issued July 28, 2009, to stop using body building products that claim to contain steroids or steroid-like substances.
Source: www.fda.gov

Survey Shows Gains in Food-Label Use, Health/Diet Awareness

noreply@blogger.com (Network) — Fri, 05 Mar 2010 21:32:00 +0000

Survey Shows Gains in Food-Label Use, Health/Diet Awareness
FDA has released findings from its latest Health & Diet Survey, which offers a snapshot of the nation's dietary habits.
Source: www.fda.gov

Preventing Medical Errors: Warning on Counterfeit Alli
FDA is warning the public about a potentially dangerous counterfeit version of the weight-loss drug Alli (orlistat). To date, all the counterfeits seem to have been sold on the internet. The genuine version of Alli, which is approved by FDA for ove...
Source: www.accessdata.fda.gov

FDA Urges Safe Use of Certain Inhaled Asthma Medicines
FDA has issued recommendations on how inhaled medications called Long-Acting Beta-Agonists (LABAs) should be used to treat asthma. Among these: LABAs should never be used alone in the treatment of asthma.
Source: www.fda.gov

Upcoming Webinar to Inform Public About Access to Investigational Drugs
On Tuesday, Feb. 23, 2010, FDA experts will host an online session and invite questions from the public on accessing investigational, or experimental, drugs.
Source: www.fda.gov

Reporting Problems to FDA (video)
This guide provides tips and a quick-reference chart to help you report a problem to FDA.
Source: www.fda.gov

Avoid Maalox Mix-Ups
Confusion over liquid Maalox products has resulted in serious medication errors. Here’s how to choose the right product for your condition.
Source: www.fda.gov

Coping With Memory Loss
A look at various causes of memory loss and treatment approaches.
Source: www.fda.gov

Eat for a Healthy Heart

noreply@blogger.com (Network) — Thu, 04 Mar 2010 01:00:00 +0000

Eat for a Healthy Heart
Eating healthily can help reduce your risk for the number one killer in the United States—heart disease.
Source: www.fda.gov

Recalls and Safety Alerts: Don't Use Thermoflect Products with MRI
The manufacturer Encompass Group is alerting healthcare professionals that Thermoflect products should not be used in an MRI environment. These products, such as blankets and apparel, are intended to prevent hypothermia by keeping patients warm usin...
Source: www.accessdata.fda.gov

Recalls and Safety Alerts: Valproate Sodium and Birth Defects
FDA is reminding healthcare professionals and patients about an increased risk of birth defects in infants whose mothers took valproate sodium and related products during pregnancy. These drugs, which are used to treat epilepsy, bipolar disorder and...
Source: www.accessdata.fda.gov

Recalls and Safety Alerts: Cleviprex Recalled due to Particulates
Here's information about a recall of certain lots of Cleviprex injectable emulsion, an antihypertensive drug made by The Medicines Company. Vials in the recalled lots may contain particulate matter which has been found to be inert stainless ste...
Source: www.accessdata.fda.gov

FDA's MedWatch Safety Alerts: November 2009
FDA has issued recent safety alerts on these medical products.
Source: www.fda.gov

Reporting Problems to FDA (video)
This guide provides tips and a quick-reference chart to help you report a problem to FDA.
Source: www.fda.gov

Food Safety Tips for Healthy Holidays
FDA gives consumers practical food safety tips to help prevent foodborne illness
Source: www.fda.gov

Avoid Maalox Mix-Ups
Confusion over liquid Maalox products has resulted in serious medication errors. Here’s how to choose the right product for your condition.
Source: www.fda.gov

USDA and FDA Coordinating Efforts to Ensure Safety of Produce

noreply@blogger.com (Network) — Tue, 02 Mar 2010 16:19:00 +0000

USDA and FDA Coordinating Efforts to Ensure Safety of Produce
The U.S. Department of Agriculture (USDA) and the Food and Drug Administration are working together to achieve the goals of enhancing the safety and quality of fresh produce in ways that take into account the wide diversity of farming operations. We are committed to leveraging the expertise of our partner agencies and working together to ensure that our current produce safety and quality activities are complementary and consistent. While USDA’s Agricultural Marketing Service (AMS) is in the midst of evaluating a proposed marketing agreement for the leafy green industry, the FDA is currently developing a proposed produce safety regulation. It is our expectation that these products will take into account the diverse nature of farming operations and that any marketing agreement would conform to any regulations that may be promulgated by FDA.
Source: www.fda.gov

FDA Teams with Everyday Health to Expand Reach of Health Information
FDA expands its reach to millions of consumers through a new partnership with Everyday Health.
Source: www.fda.gov

FDA to Examine the Safety of Caffeinated Alcoholic Beverages
Concerns about the health and safety hazards posed by caffeinated alcoholic beverages have prompted FDA action.
Source: www.fda.gov

FDA 101: Smoking Cessation Products
Numerous smoking cessation products have FDA approval. It's important to know the benefits, potential side effects, and risks associated with these products as you decide whether to use them.
Source: www.fda.gov

FDA Approves Rituxan to Treat Chronic Lymphocytic Leukemia
The U.S. Food and Drug Administration today approved Rituxan (rituximab) to treat certain patients with chronic lymphocytic leukemia (CLL), a slowly progressing blood and bone marrow cancer.
Source: www.fda.gov

U.S. Attorney News Release: Medical Technician Sentenced to 30 Years
Statement by U.S. attorney David Gaouette regarding the sentencing of Kristen Parker
Source: www.fda.gov

Regulatory Science Update: FDA and International Serious Adverse Events Consortium Complete Third Data Release
The U.S. Food and Drug Administration and the International Serious Adverse Event Consortium (SAEC) today announced the third release of data on the genetic basis of drug-induced liver injury (DILI) and serious skin reactions (SSRs).
Source: www.fda.gov

Avandia (rosiglitazone): Ongoing Review of Cardiovascular Safety

noreply@blogger.com (Network) — Mon, 01 Mar 2010 20:55:00 +0000

Avandia (rosiglitazone): Ongoing Review of Cardiovascular Safety
FDA is reviewing data from a large, long-term clinical study on possible risks for cardiovascular outcomes associated with use of rosiglitazone.
Source: www.fda.gov

BD Q-Syte Luer Access Devices: Recall
Device may cause an air embolism or leakage of blood and/or therapy, which may result in serious injury or death.
Source: www.fda.gov

Hettich Centrifuges with 2050 and 2076 Plastic Rotors: Recall
Plastic centrifuge rotor may crack, break apart and be forcefully ejected.
Source: www.fda.gov

FDA Approves Therapy to Treat Gaucher Disease
The U.S. Food and Drug Administration has approved velaglucerase alfa for injection (VPRIV) to treat children and adults with a form of the rare genetic disorder Gaucher disease.
Source: www.fda.gov

Safesheath CSG Coronary Sinus Guide Hemostatic Introducer System with Infusion Sideport by Thomas Medical
Sheath tip may break off and separate while the sheath is inside a blood vessel, leading to serious injury or death.
Source: www.fda.gov

Indoor Tanning: The Risks of Ultraviolet Rays
There’s no such thing as a safe tan. Whether from the sun or from sunlamps used in tanning equipment, ultraviolet rays pose a health risk.
Source: www.fda.gov

FDA Approves Pneumococcal Disease Vaccine with Broader Protection
The U.S. Food and Drug Administration today approved Prevnar 13, a pneumococcal 13-valent conjugate vaccine for infants and young children ages 6 weeks through 5 years. Prevnar 13 will be the successor to Prevnar, the pneumococcal 7-valent conjugate vaccine licensed by the FDA in 2000 to prevent invasive pneumococcal disease (IPD) and otitis media. The new vaccine extends the protection to six additional types of the disease causing bacteria.
Source: www.fda.gov

Erythropoiesis-Stimulating Agents (ESAs): Procrit, Epogen and Aranesp: Drug Safety Communication
FDA requires REMS that ensures that only those hospitals and healthcare professionals who have enrolled and completed training in risk management program will prescribe and dispense ESAs to patients with cancer.
Source: www.fda.gov

Videx/Videx EC (didanosine): Labeling Revision - Risk of Non-Cirrhotic Portal Hypertension
Risk information added to Warnings/Precautions section and data summary provided
Source: www.fda.gov

FDA Warns about Serious Side Effects from Maalox Product Mix-Ups
The U.S. Food and Drug Administration today warned consumers about the potential for serious side effects from mistakenly using Maalox Total Relief instead of other Maalox products. The two products are intended for the relief of different symptoms and contain different active ingredients.
Source: www.fda.gov

Exjade (deferasirox): Boxed Warning

noreply@blogger.com (Network) — Sun, 28 Feb 2010 06:32:00 +0000

Exjade (deferasirox): Boxed Warning
Changes to Prescribing Information re: risk of renal impairment/failure, hepatic impairment/failure or gastrointestinal hemorrhage.
Source: www.fda.gov

Cardiac Science Automated External Defibrillators (Powerheart, Cardiovive, CardioLife models): Recall
Device may not be able to deliver therapy during a cardiac resuscitation attempt.
Source: www.fda.gov

Safety Review of Avandia (Rosiglitazone)
Description: FDA offers advice to people who take the diabetes drug Avandia (rosiglitazone) while the agency continues to review data on possible heart-related risks associated with the drug.
Source: www.fda.gov

FDA's MedWatch Safety Alerts: November 2009
FDA has issued recent safety alerts on these medical products.
Source: www.fda.gov

Erythropoiesis-Stimulating Agents (ESAs): Procrit, Epogen and Aranesp: Drug Safety Communication
FDA requires REMS that ensures that only those hospitals and healthcare professionals who have enrolled and completed training in risk management program will prescribe and dispense ESAs to patients with cancer.
Source: www.fda.gov

Velcade (bortezomib): Starting Dose Adjustments for Patients with Hepatic Impairment
Patients with moderate or severe hepatic impairment should be treated with reduced starting doses and closely monitored.
Source: www.fda.gov

StatSpin Express 4 Centrifuges Model 510: Recall
Rotor may break and eject pieces of the rotor which may cause serious physical injury to bystanders and expose them to blood-borne infectious micro-organisms.
Source: www.fda.gov

Hettich Centrifuges with 2050 and 2076 Plastic Rotors: Recall
Plastic centrifuge rotor may crack, break apart and be forcefully ejected.
Source: www.fda.gov

Recalls and Safety Alerts: Chondrolysis with Continuously Infused Local Anesthetics
FDA is notifying healthcare professionals about chondrolysis in patients receiving continuous intra-articular infusion of local anesthetics to treat post-surgical pain. FDA has received a number of reports of cartilage necrosis and destruction in th...
Source: www.accessdata.fda.gov

OneTouch SureStep Test Strips (LifeScan): Recall

noreply@blogger.com (Network) — Sat, 27 Feb 2010 07:27:00 +0000

OneTouch SureStep Test Strips (LifeScan): Recall
Test strips are being recalled because they may provide falsely low glucose results when the glucose level is higher than 400 mg/dL.
Source: www.fda.gov

Edwards Lifesciences Aquarius Hemodialysis System: Recall
Clinically significant fluid imbalance and potential for users to repeatedly override the fluid imbalance alarm.
Source: www.fda.gov

Avandia (rosiglitazone): Ongoing Review of Cardiovascular Safety
FDA is reviewing data from a large, long-term clinical study on possible risks for cardiovascular outcomes associated with use of rosiglitazone.
Source: www.fda.gov

Recalls and Safety Alerts: Preventing Cross-Contamination in Endoscope Processing
The FDA, the CDC and the Department of Veterans Affairs have issued a joint safety communication cautioning healthcare facilities about the risks to patients if endoscopes and their accessories are not processed properly between patients. The commun...
Source: www.accessdata.fda.gov

Safesheath CSG Coronary Sinus Guide Hemostatic Introducer System with Infusion Sideport by Thomas Medical
Sheath tip may break off and separate while the sheath is inside a blood vessel, leading to serious injury or death.
Source: www.fda.gov

Hettich Centrifuges with 2050 and 2076 Plastic Rotors: Recall
Plastic centrifuge rotor may crack, break apart and be forcefully ejected.
Source: www.fda.gov

StatSpin Express 4 Centrifuges Model 510: Recall
Rotor may break and eject pieces of the rotor which may cause serious physical injury to bystanders and expose them to blood-borne infectious micro-organisms.
Source: www.fda.gov

Recalls and Safety Alerts: New Warnings on Norpramin
Sanofi-Aventis is notifying healthcare professionals about updated safety information for the antidepressant Norpramin (desipramine hydrochloride). The section on overdosage now notes that overdoses of this drug have resulted in a higher death rate ...
Source: www.accessdata.fda.gov

FDA Consumer Corner: Ear Candles: Ineffective and Risky
FDA is warning people not to use ear candles because they can cause serious injury. An ear candle is a hollow cone about 10 inches long made from a fabric tube soaked in beeswax or paraffin. They are promoted and sold in health food stores, health ...
Source: www.accessdata.fda.gov

BD Q-Syte Luer Access Devices: Recall
Device may cause an air embolism or leakage of blood and/or therapy, which may result in serious injury or death.
Source: www.fda.gov

Regulatory Science Update: FDA and International Serious Adverse Events Consortium Complete Third Data Release

noreply@blogger.com (Network) — Thu, 25 Feb 2010 13:35:00 +0000

Regulatory Science Update: FDA and International Serious Adverse Events Consortium Complete Third Data Release
The U.S. Food and Drug Administration and the International Serious Adverse Event Consortium (SAEC) today announced the third release of data on the genetic basis of drug-induced liver injury (DILI) and serious skin reactions (SSRs).
Source: www.fda.gov

Food Safety Tips for Healthy Holidays
FDA gives consumers practical food safety tips to help prevent foodborne illness
Source: www.fda.gov

Maryland Veal Calf Dealer Agrees to Close in Response to FDA-Initiated Action
A Maryland veal calf dealer has agreed to shut down as part of a consent decree of permanent injunction, which he entered into after being charged with repeatedly violating federal law and U.S. Food and Drug Administration regulations by selling veal calves with illegal drug residues in their edible tissues.
Source: www.fda.gov

USDA and FDA Coordinating Efforts to Ensure Safety of Produce

noreply@blogger.com (Network) — Wed, 24 Feb 2010 15:08:00 +0000

USDA and FDA Coordinating Efforts to Ensure Safety of Produce
The U.S. Department of Agriculture (USDA) and the Food and Drug Administration are working together to achieve the goals of enhancing the safety and quality of fresh produce in ways that take into account the wide diversity of farming operations. We are committed to leveraging the expertise of our partner agencies and working together to ensure that our current produce safety and quality activities are complementary and consistent. While USDA’s Agricultural Marketing Service (AMS) is in the midst of evaluating a proposed marketing agreement for the leafy green industry, the FDA is currently developing a proposed produce safety regulation. It is our expectation that these products will take into account the diverse nature of farming operations and that any marketing agreement would conform to any regulations that may be promulgated by FDA.
Source: www.fda.gov

U.S. Attorney News Release: Woman pleads guilty to poisoning salsa at Lenexa restaurant
Yini De La Torre, has pleaded guilty to putting poison in salsa served to patrons at Mi Ranchito restaurant in Lenexa, Kan. She pleaded guilty to one count of conspiracy to tamper with a consumer product. In her plea, she admitted that while working as a waitress at the Mi Ranchito restaurant in Lenexa she twice added Methomyl-based pesticide to salsa she prepared.
Source: www.fda.gov

FDA Announces New Safety Controls for Long-Acting Beta Agonists, Medications Used to Treat Asthma
The U.S. Food and Drug Administration today announced that drugs in the class of long-acting beta agonists (LABAs) should never be used alone in the treatment of asthma in children or adults. Manufacturers will be required to include this warning in the product labels of these drugs, along with taking other steps to reduce the overall use of these medications.
Source: www.fda.gov

FDA Unveils Initiative to Reduce Unnecessary Radiation Exposure from Medical Imaging
The U.S. Food and Drug Administration today announced an initiative to reduce unnecessary radiation exposure from three types of medical imaging procedures: computed tomography (CT), nuclear medicine studies, and fluoroscopy. These procedures are the greatest contributors to total radiation exposure within the U.S. population and use much higher radiation doses than other radiographic procedures, such as standard X-rays, dental X-rays, and mammography.
Source: www.fda.gov

FDA Update on the Investigation into the Salmonella Montevideo Outbreak
The Food and Drug Administration, along with the Centers for Disease Control and Prevention and the U.S. Department of Agriculture’s Food Safety and Inspection Service, continues to work closely with the Rhode Island Department of Health and other states in the investigation of an outbreak of Salmonella Montevideo infections associated with certain Italian-style sausage products including salami/salame.
Source: www.fda.gov

Avoid Maalox Mix-Ups
Confusion over liquid Maalox products has resulted in serious medication errors. Here’s how to choose the right product for your condition.
Source: www.fda.gov

Avoid Maalox Mix-Ups

noreply@blogger.com (Network) — Tue, 23 Feb 2010 17:32:00 +0000

Avoid Maalox Mix-Ups
Confusion over liquid Maalox products has resulted in serious medication errors. Here’s how to choose the right product for your condition.
Source: www.fda.gov

Indoor Tanning: The Risks of Ultraviolet Rays
There’s no such thing as a safe tan. Whether from the sun or from sunlamps used in tanning equipment, ultraviolet rays pose a health risk.
Source: www.fda.gov

Safesheath CSG Coronary Sinus Guide Hemostatic Introducer System with Infusion Sideport by Thomas Medical

noreply@blogger.com (Network) — Mon, 22 Feb 2010 20:23:00 +0000

Safesheath CSG Coronary Sinus Guide Hemostatic Introducer System with Infusion Sideport by Thomas Medical
Sheath tip may break off and separate while the sheath is inside a blood vessel, leading to serious injury or death.
Source: www.fda.gov

Erythropoiesis-Stimulating Agents (ESAs): Procrit, Epogen and Aranesp: Drug Safety Communication
FDA requires REMS that ensures that only those hospitals and healthcare professionals who have enrolled and completed training in risk management program will prescribe and dispense ESAs to patients with cancer.
Source: www.fda.gov

MuscleMaster.com Products Sold on Internet as Dietary Supplements: Recall
Dietary supplements recalled due to undeclared steroids in products, posing risk of acute liver injury.
Source: www.fda.gov

FDA 101: Smoking Cessation Products

noreply@blogger.com (Network) — Sat, 20 Feb 2010 18:49:00 +0000

Exjade (deferasirox): Boxed Warning

noreply@blogger.com (Network) — Fri, 19 Feb 2010 15:27:00 +0000

Exjade (deferasirox): Boxed Warning
Changes to Prescribing Information re: risk of renal impairment/failure, hepatic impairment/failure or gastrointestinal hemorrhage.
Source: www.fda.gov

Long-Acting Beta-Agonists (LABAs): New Safe Use Requirements
FDA requires risk management plan and class-labeling changes for all LABAs.
Source: www.fda.gov

Tysabri (Natalizumab): Update of Healthcare Professional Information
Risk of developing progressive multifocal leukoencephalopathy (PML) increases with increasing duration of exposure to Tysabri.
Source: www.fda.gov

Edwards Lifesciences Aquarius Hemodialysis System: Recall
Clinically significant fluid imbalance and potential for users to repeatedly override the fluid imbalance alarm.
Source: www.fda.gov

Tylenol Arthritis Pain Caplet, 100 count bottles: Recall of all lots
[UPDATE 01/15/2010] Recall expanded from December 2009 due to reports of moldy, musty, or mildew-like odor that was associated with nausea, stomach pain, vomiting and diarrhea. Posted 12/28/2009
Source: www.fda.gov

Safesheath CSG Coronary Sinus Guide Hemostatic Introducer System with Infusion Sideport by Thomas Medical
Sheath tip may break off and separate while the sheath is inside a blood vessel, leading to serious injury or death.
Source: www.fda.gov

Velcade (bortezomib): Starting Dose Adjustments for Patients with Hepatic Impairment
Patients with moderate or severe hepatic impairment should be treated with reduced starting doses and closely monitored.
Source: www.fda.gov

Recalls and Safety Alerts: Synex II Spinal Implant Recalled
In September, the device company Synthes USA recalled the Synex II Vertebral Body Replacement device, a titanium implant used to replace an unstable or damaged vertebral body in the T1 to L5 portion of the spine. The devices were recalled after ...
Source: www.accessdata.fda.gov

FDA Unveils Initiative to Reduce Unnecessary Radiation Exposure from Medical Imaging

noreply@blogger.com (Network) — Thu, 18 Feb 2010 14:27:00 +0000

FDA Unveils Initiative to Reduce Unnecessary Radiation Exposure from Medical Imaging
The U.S. Food and Drug Administration today announced an initiative to reduce unnecessary radiation exposure from three types of medical imaging procedures: computed tomography (CT), nuclear medicine studies, and fluoroscopy. These procedures are the greatest contributors to total radiation exposure within the U.S. population and use much higher radiation doses than other radiographic procedures, such as standard X-rays, dental X-rays, and mammography.
Source: www.fda.gov

Consejos de seguridad de los alimentos para unas fiestas saludables

noreply@blogger.com (Network) — Wed, 17 Feb 2010 08:05:00 +0000

Consejos de seguridad de los alimentos para unas fiestas saludables
Los consumidores tienen una función que cumplir, sobre todo cuando manipulan los alimentos en el hogar.
Source: www.fda.gov

FDA Teams with Everyday Health to Expand Reach of Health Information
FDA expands its reach to millions of consumers through a new partnership with Everyday Health.
Source: www.fda.gov

FDA to Examine the Safety of Caffeinated Alcoholic Beverages
Concerns about the health and safety hazards posed by caffeinated alcoholic beverages have prompted FDA action.
Source: www.fda.gov

Warning: Counterfeit Alli
FDA warns of counterfeit weight-loss drug Alli 60 mg capsules (120 count refill pack) sold over the Internet.
Source: www.fda.gov

Indoor Tanning: The Risks of Ultraviolet Rays
There’s no such thing as a safe tan. Whether from the sun or from sunlamps used in tanning equipment, ultraviolet rays pose a health risk.
Source: www.fda.gov

Negative Pressure Wound Devices Draw FDA Notice, Advice
FDA has issued a notification for health professionals and advice for patients, linked to reports of rare but serious complications, including deaths, arising from use of negative pressure wound therapy.
Source: www.fda.gov

Postes internationaux de la FDA: Améliorer la sécurité des aliments et des produits médicaux importés

noreply@blogger.com (Network) — Tue, 16 Feb 2010 16:54:00 +0000

Postes internationaux de la FDA: Améliorer la sécurité des aliments et des produits médicaux importés
La mutation des membres de son personnel dans certaines régions à l’étranger est un facteur majeur de sa stratégie pour intensifier la surveillance des aliments et des produits médicaux importés.
Source: www.fda.gov

Coping With Memory Loss
A look at various causes of memory loss and treatment approaches.
Source: www.fda.gov

Eat for a Healthy Heart
Eating healthily can help reduce your risk for the number one killer in the United States—heart disease.
Source: www.fda.gov

FDA to Examine the Safety of Caffeinated Alcoholic Beverages
Concerns about the health and safety hazards posed by caffeinated alcoholic beverages have prompted FDA action.
Source: www.fda.gov

FDA's MedWatch Safety Alerts: November 2009
FDA has issued recent safety alerts on these medical products.
Source: www.fda.gov

FDA's MedWatch Safety Alerts: October 2009
FDA has issued recent safety alerts on these medical products.
Source: www.fda.gov

Indoor Tanning: The Risks of Ultraviolet Rays
There’s no such thing as a safe tan. Whether from the sun or from sunlamps used in tanning equipment, ultraviolet rays pose a health risk.
Source: www.fda.gov

Meridia (sibutramine hydrochloride): Follow-Up to an Early Communication about an Ongoing Safety Review

noreply@blogger.com (Network) — Sun, 14 Feb 2010 16:17:00 +0000

Meridia (sibutramine hydrochloride): Follow-Up to an Early Communication about an Ongoing Safety Review
Contraindication to use in patients with history of cardiovascular disease.
Source: www.fda.gov

Velcade (bortezomib): Starting Dose Adjustments for Patients with Hepatic Impairment
Patients with moderate or severe hepatic impairment should be treated with reduced starting doses and closely monitored.
Source: www.fda.gov

Videx/Videx EC (didanosine): Labeling Revision - Risk of Non-Cirrhotic Portal Hypertension
Risk information added to Warnings/Precautions section and data summary provided
Source: www.fda.gov

Eat for a Healthy Heart
Eating healthily can help reduce your risk for the number one killer in the United States—heart disease.
Source: www.fda.gov

Negative Pressure Wound Devices Draw FDA Notice, Advice
FDA has issued a notification for health professionals and advice for patients, linked to reports of rare but serious complications, including deaths, arising from use of negative pressure wound therapy.
Source: www.fda.gov

Zyprexa (olanzapine): Use in Adolescents
Clinicians should consider the potential long-term risks when prescribing to adolescents.
Source: www.fda.gov

ev3 Endovascular Inc. Trailblazer Support Catheter: Class I Recall
Device may crack near the radiopaque marker band, potentially resulting in serious patient injury.
Source: www.fda.gov

Indoor Tanning: The Risks of Ultraviolet Rays
There’s no such thing as a safe tan. Whether from the sun or from sunlamps used in tanning equipment, ultraviolet rays pose a health risk.
Source: www.fda.gov

McNeil Consumer Healthcare Over-The-Counter Products: Recall
December 2009 recall expanded to multiple products.
Source: www.fda.gov

FDA 101: Smoking Cessation Products

noreply@blogger.com (Network) — Sat, 13 Feb 2010 14:00:00 +0000

FDA 101: Smoking Cessation Products
Numerous smoking cessation products have FDA approval. It's important to know the benefits, potential side effects, and risks associated with these products as you decide whether to use them.
Source: www.fda.gov

FDA to Examine the Safety of Caffeinated Alcoholic Beverages
Concerns about the health and safety hazards posed by caffeinated alcoholic beverages have prompted FDA action.
Source: www.fda.gov

美国食品药物管理局的国际分支机构：改进进口食品和医疗产品的安全
将美国食品药物管理局人员派往某些海外地区的分支机构是该局扩大对进口食品和药品监督策略的一个重要部分。
Source: www.fda.gov

FDA's MedWatch Safety Alerts: November 2009
FDA has issued recent safety alerts on these medical products.
Source: www.fda.gov

Hettich Centrifuges with 2050 and 2076 Plastic Rotors: Recall
Plastic centrifuge rotor may crack, break apart and be forcefully ejected.
Source: www.fda.gov

Indoor Tanning: The Risks of Ultraviolet Rays
There’s no such thing as a safe tan. Whether from the sun or from sunlamps used in tanning equipment, ultraviolet rays pose a health risk.
Source: www.fda.gov

FDA Requests $4.03 Billion to Transform Food Safety System, Invest in Medical Product Safety, Regulatory Science

noreply@blogger.com (Network) — Fri, 12 Feb 2010 05:13:00 +0000

FDA Requests $4.03 Billion to Transform Food Safety System, Invest in Medical Product Safety, Regulatory Science
The U.S. Food and Drug Administration is requesting $4.03 billion to promote and protect public health as part of the President’s fiscal year 2011 budget – a 23 percent increase over the agency’s current $3.28 billion budget. The FY 2011 request, which covers the period of Oct.1, 2010, through Sept. 30, 2011, includes increases of $146 million in budget authority and $601 million in industry user fees.
Source: www.fda.gov

Edwards Lifesciences Aquarius Hemodialysis System: Recall
Clinically significant fluid imbalance and potential for users to repeatedly override the fluid imbalance alarm.
Source: www.fda.gov

Videx/Videx EC (didanosine): Labeling Revision - Risk of Non-Cirrhotic Portal Hypertension
Risk information added to Warnings/Precautions section and data summary provided
Source: www.fda.gov

FDA Unveils Initiative to Reduce Unnecessary Radiation Exposure from Medical Imaging
The U.S. Food and Drug Administration today announced an initiative to reduce unnecessary radiation exposure from three types of medical imaging procedures: computed tomography (CT), nuclear medicine studies, and fluoroscopy. These procedures are the greatest contributors to total radiation exposure within the U.S. population and use much higher radiation doses than other radiographic procedures, such as standard X-rays, dental X-rays, and mammography.
Source: www.fda.gov

Infusion Set Needles [Manufactured by Nipro for Exelint]: Recall
Class I recall due to "coring" or dislodging of silicone cores or slivers from the ports into which they are inserted.
Source: www.fda.gov

Velcade (bortezomib): Starting Dose Adjustments for Patients with Hepatic Impairment
Patients with moderate or severe hepatic impairment should be treated with reduced starting doses and closely monitored.
Source: www.fda.gov

FDA Issues Guidance to Help Streamline Medical Device Clinical Trials
The U.S. Food and Drug Administration today issued guidance on Bayesian statistical methods in the design and analysis of medical device clinical trials that could result in less costly and more efficient patient studies.
Source: www.fda.gov

Tylenol Arthritis Pain Caplet, 100 count bottles: Recall of all lots
[UPDATE 01/15/2010] Recall expanded from December 2009 due to reports of moldy, musty, or mildew-like odor that was associated with nausea, stomach pain, vomiting and diarrhea. Posted 12/28/2009
Source: www.fda.gov

McNeil Consumer Healthcare Over-The-Counter Products: Recall
December 2009 recall expanded to multiple products.
Source: www.fda.gov

Nzu, Traditional Remedy for Morning Sickness

noreply@blogger.com (Network) — Thu, 11 Feb 2010 00:44:00 +0000

Nzu, Traditional Remedy for Morning Sickness
Consumers, especially pregnant or breastfeeding women, advised to avoid product because of the potential health risks from high levels of lead and arsenic
Source: www.fda.gov

Meridia (sibutramine hydrochloride): Follow-Up to an Early Communication about an Ongoing Safety Review
Contraindication to use in patients with history of cardiovascular disease.
Source: www.fda.gov

FDA Statement on the Investigation into the Salmonella Montevideo Outbreak

noreply@blogger.com (Network) — Wed, 10 Feb 2010 04:32:00 +0000

FDA Statement on the Investigation into the Salmonella Montevideo Outbreak
The Food and Drug Administration, along with the Centers for Disease Control and Prevention and the U.S. Department of Agriculture, is working closely with the Rhode Island Department of Health and other states in the investigation of an outbreak of Salmonella Montevideo infection associated with certain salami products.
Source: www.fda.gov

United States Seizes more than 1500 Cases of Food from Wisconsin Distribution Warehouse
At the request of the U.S. Food and Drug Administration, U.S. Marshals on Tuesday seized a wide range of human and animal food products stored under insanitary conditions at Mid-States Closeouts, a distribution warehouse in Ellsworth, Wis. The products were seized under a warrant issued by the U.S. District Court for the Western District of Wisconsin.
Source: www.fda.gov

FDA Announces Safety Risk Associated with HIV Drug
The U.S. Food and Drug Administration today announced that non-cirrhotic portal hypertension, a rare, but serious, liver disorder, has been reported in some HIV patients taking Videx/Videx EC (didanosine). Videx is an antiretroviral medicine first approved by the FDA in 1991. Videx EC is a delayed-release version of Videx approved in 2000. Videx/Videx EC is used in combination with other antiretroviral medicines to treat HIV infection in children and adults.
Source: www.fda.gov

FDA Approves New Indication for Crestor
On Feb. 8 the U.S. Food and Drug Administration approved the cholesterol-lowering medication Crestor (rosuvastatin) for some patients who are at increased risk of heart disease but have not been diagnosed with it. The new indication is for reducing the likelihood of a heart attack or stroke or the need for a procedure to treat blocked or narrowed arteries in patients who have never been told they have heart disease but are nevertheless at increased risk of a cardiac event.
Source: www.fda.gov

FDA Approves New Treatment for Type 2 Diabetes
The U.S. Food and Drug Administration today approved Victoza (liraglutide), a once-daily injection to treat type 2 diabetes in some adults.
Source: www.fda.gov

FDA Collaboration Seeks to Speed Development of Pneumococcal Vaccines for Children in Developing Countries
The U.S. Food and Drug Administration (FDA) today announced a collaboration with PATH to advance development of a vaccine to protect children against diseases caused by Streptococcus pneumoniae (pneumococcus), especially pneumonia. Worldwide, the bacterium also causes infections of the brain (meningitis), blood (sepsis), and middle ear (otitis media) and each year kills about 1 million children younger than 5 years of age. The collaboration aims to improve the techniques used to produce effective, safe, and affordable vaccines against pneumococcal disease for children in the developing world. PATH is an international nonprofit organization based in Seattle that creates sustainable, culturally relevant, and affordable solutions to help communities worldwide to break cycles of poor health. The collaborative project, expected to run for two years, is being conducted under the Cooperative Research and Development Agreement (CRADA) program. The program allows federal laboratories and businesses to form partnerships that help expedite research activities.
Source: www.fda.gov

FDA Issues Guidance to Help Streamline Medical Device Clinical Trials

noreply@blogger.com (Network) — Tue, 09 Feb 2010 08:38:00 +0000

FDA Issues Guidance to Help Streamline Medical Device Clinical Trials
The U.S. Food and Drug Administration today issued guidance on Bayesian statistical methods in the design and analysis of medical device clinical trials that could result in less costly and more efficient patient studies.
Source: www.fda.gov

McNeil Consumer Healthcare Over-The-Counter Products: Recall

noreply@blogger.com (Network) — Sat, 06 Feb 2010 08:44:00 +0000

McNeil Consumer Healthcare Over-The-Counter Products: Recall
December 2009 recall expanded to multiple products.
Source: www.fda.gov

Nipro GlucoPro Insulin Syringes: Recall
Needles may become detached and remain in the skin.
Source: www.fda.gov

FDA Approves Xiaflex for Debilitating Hand Condition
The U.S. Food and Drug Administration today approved Xiaflex (collagenase clostridium histolyticum) as the first drug to treat a progressive hand disease known as Dupuytren's contracture, which can affect a person’s ability to straighten and properly use their fingers.
Source: www.fda.gov

U.S. Attorney New Release: Bellevue, Washington Salon Owner Sentenced in Connection with Unlicensed Cosmetic Treatments
According to testimony at trial and records filed in the case, FAITH HE used counterfeit Botox© and Restylane© on customers at her Bellevue beauty salon. FAITH HE was not a medical doctor licensed to use injectable treatments for wrinkle removal such as Botox and Restylane.
Source: www.fda.gov

Hettich Centrifuges with 2050 and 2076 Plastic Rotors: Recall
Plastic centrifuge rotor may crack, break apart and be forcefully ejected.
Source: www.fda.gov

Safesheath CSG Coronary Sinus Guide Hemostatic Introducer System with Infusion Sideport by Thomas Medical
Sheath tip may break off and separate while the sheath is inside a blood vessel, leading to serious injury or death.
Source: www.fda.gov

Indoor Tanning: The Risks of Ultraviolet Rays

noreply@blogger.com (Network) — Thu, 04 Feb 2010 20:39:00 +0000

Indoor Tanning: The Risks of Ultraviolet Rays
There’s no such thing as a safe tan. Whether from the sun or from sunlamps used in tanning equipment, ultraviolet rays pose a health risk.
Source: www.fda.gov

Postes internationaux de la FDA: Améliorer la sécurité des aliments et des produits médicaux importés
La mutation des membres de son personnel dans certaines régions à l’étranger est un facteur majeur de sa stratégie pour intensifier la surveillance des aliments et des produits médicaux importés.
Source: www.fda.gov