June 20, 2009Warning on Hydroxycut Products Warning on Hydroxycut Products
FDA is warning consumers to stop using Hydroxycut products because of serious health risks. One death due to liver failure has been reported to the agency. Source: www.fda.gov Are You Taking Medication as Prescribed? Strategies for improving medication adherence. Source: www.fda.gov Patients Alerted to Pacemaker Recall FDA has alerted patients to the Class I recall of certain Medtronic Kappa and Sigma pacemakers Source: www.fda.gov Recalls and Safety Alerts: Recall of Zencore Plus Bodee LLC is recalling its supplement product called Zencore Plus after FDA laboratory analysis showed that the product contains benzamidenafil. This is a newly discovered PDE5 inhibitor that is likely to have the same pharmacologic properties as si... Source: www.accessdata.fda.gov FDA's MedWatch Safety Alerts: June 2009 FDA has issued recent safety alerts on these medical products. Source: www.fda.gov June 19, 2009Ensuring Safe Use of Contact Lens Solution Ensuring Safe Use of Contact Lens Solution
Advice from FDA for using contact lens solution Source: www.fda.gov Recalls and Safety Alerts: Recalls of Digoxin and Propafenone Tablets FDA has posted information about two cardiac drugs that were recently recalled because of variability in the size of the tablets: ? Caraco Pharmaceutical Laboratories, a manufacturer of generic pharmaceuticals, recalled some of their digoxin table... Source: www.accessdata.fda.gov Safety Concerns About Testosterone Gel Safety Concerns About Testosterone Gel
Side effects in children prompt additional warnings on testosterone gel products for adults. Source: www.fda.gov La FDA promueve la apertura y la transparencia hacia el público La FDA está trabajando para que el público tenga un mejor acceso a toda información de utilidad sobre sus actividades y su toma de decisiones. Source: www.fda.gov Ensuring Safe Use of Contact Lens Solution Advice from FDA for using contact lens solution Source: www.fda.gov FDA Promotes Openness and Transparency to Public FDA is working to make useful information about FDA activities and decision making more readily available to the public. Source: www.fda.gov FDA Advisory About Levemir Insulin Stolen Levemir insulin has reappeared on the market; check your lot number if you use this insulin. Source: www.fda.gov H1N1 Flu: FDA Responds Quickly to Protect the Public's Health FDA is addressing the H1N1 flu outbreak with a team-based incident management approach Source: www.fda.gov FDA's MedWatch Safety Alerts: June 2009 FDA has issued recent safety alerts on these medical products. Source: www.fda.gov New Labeling Required for OTC Pain and Fever Medicines On April 28, 2009, FDA issued a final rule that requires manufacturers of over-the-counter (OTC) pain relievers and fever reducers to revise their labeling Source: www.fda.gov Warning on Hydroxycut Products FDA is warning consumers to stop using Hydroxycut products because of serious health risks. One death due to liver failure has been reported to the agency. Source: www.fda.gov Safety Concerns About Testosterone Gel Safety Concerns About Testosterone Gel
Side effects in children prompt additional warnings on testosterone gel products for adults. Source: www.fda.gov The Scoop on Whole Grains What are whole grains and how much should you eat? Source: www.fda.gov New Labeling Required for OTC Pain and Fever Medicines On April 28, 2009, FDA issued a final rule that requires manufacturers of over-the-counter (OTC) pain relievers and fever reducers to revise their labeling Source: www.fda.gov Ensuring Safe Use of Contact Lens Solution Advice from FDA for using contact lens solution Source: www.fda.gov Ceftriaxone (marketed as Rocephin and generics) Ceftriaxone (marketed as Rocephin and generics) Source: www.fda.gov June 18, 2009Dietary Supplements Distributed by Universal ABC Beauty Supply International, Inc. Dietary Supplements Distributed by Universal ABC Beauty Supply International, Inc.
Source: www.fda.gov Recalls and Safety Alerts: Recall of Zencore Plus Recalls and Safety Alerts: Recall of Zencore Plus
Bodee LLC is recalling its supplement product called Zencore Plus after FDA laboratory analysis showed that the product contains benzamidenafil. This is a newly discovered PDE5 inhibitor that is likely to have the same pharmacologic properties as si... Source: www.accessdata.fda.gov FDA Issues Safety Communication about an Ongoing Review of Stimulant Medications Used in Children with ADHD There may be an association between the use of stimulant medications for attention- deficit hyperactivity disorder, known as ADHD, and sudden cardiac death in healthy children, according to a study published in the American Journal of Psychiatry. But the U.S. Food and Drug Administration says that, because of the study’s limitations, parents should not stop a child’s stimulant medication based on the study. The FDA recommends that parents should discuss concerns about the use of these medications with the prescribing health care professional. Source: www.fda.gov U.S. Attorney News Release: International Medical Device Maker and Four Executives Charged in Connection with Unlawful Clinical Trials U.S. Attorney news release Source: www.fda.gov FDA Promotes Openness and Transparency to Public FDA is working to make useful information about FDA activities and decision making more readily available to the public. Source: www.fda.gov FDA Advises Consumers Not To Use Certain Zicam Cold Remedies The U.S. Food and Drug Administration today advised consumers to stop using three products marketed over-the-counter as cold remedies because they are associated with the loss of sense of smell (anosmia). Anosmia may be long-lasting or permanent. Source: www.fda.gov FDA Approves Injectable Form of Ibuprofen The U.S. Food and Drug Administration today approved Caldolor, the first injectable dosage form of the common pain medication ibuprofen, to treat pain and fever. Source: www.fda.gov U.S. Attorney News Release: Business Owners Plead Guilty to Distributing Tainted Ingredient Used in Pet Food KANSAS CITY, Mo. – Matt J. Whitworth, Acting United States Attorney for the Western District of Missouri, announced that a Nevada company and its owners pleaded guilty in federal court today to distributing a tainted ingredient used to make pet food, which resulted in a nationwide recall of pet food and the death and serious illness of countless pets across the United States in 2007. Source: www.fda.gov U.S. Attorney News Release: California Man Sentenced for Prescription Drug Diversion CONCORD, NEW HAMPSHIRE: Thomas Lavery, of Irvine, CA, was sentenced to 52 months of incarceration to be followed by three years of supervised release for illegally distributing large quantities of Serostim, an HIV drug, which were illegally purchased from illegitimate sources and then illegally sold to wholesale distributors in various parts of the country, using falsified paperwork. Judge McAuliffe also entered an order of forfeiture against Lavery for the sum of $1,009,460. Source: www.fda.gov Recalls and Safety Alerts: Raptiva Withdrawn from the Market Genentech is conducting a phased market withdrawal of the psoriasis drug Raptiva (efalizumab). The company is doing this because taking the drug carries the risk of developing progressive multifocal leukoencephalopathy (PML). PML, which is caused by... Source: www.accessdata.fda.gov Safety Concerns About Testosterone Gel Side effects in children prompt additional warnings on testosterone gel products for adults. Source: www.fda.gov June 17, 2009FDA Warns Consumers to Stop Using Hydroxycut Products FDA Warns Consumers to Stop Using Hydroxycut Products
The U.S. Food and Drug Administration is warning consumers to immediately stop using Hydroxycut products by Iovate Health Sciences Inc., of Oakville, Ontario and distributed by Iovate Health Sciences USA Inc. of Blasdell, N.Y. Some Hydroxycut products are associated with a number of serious liver injuries. Iovate has agreed to recall Hydroxycut products from the market. Source: www.fda.gov Warning on Hydroxycut Products FDA is warning consumers to stop using Hydroxycut products because of serious health risks. One death due to liver failure has been reported to the agency. Source: www.fda.gov Treating Cushing's Disease in Dogs Medications, including a recently approved drug, can help manage this disease that most commonly occurs in middle-aged and older dogs. Source: www.fda.gov Consumers Warned Not to Use Clarcon Skin Products The U.S. Food and Drug Administration announced today that Clarcon Biological Chemistry Laboratory Inc. of Roy, Utah, is voluntarily recalling some skin sanitizers and skin protectants marketed under several different brand names because of high levels of disease-causing bacteria found in the product during a recent inspection. The FDA is warning consumers to not use any Clarcon products. Source: www.fda.gov FDA Advises Consumers Not To Use Certain Zicam Cold Remedies The U.S. Food and Drug Administration today advised consumers to stop using three products marketed over-the-counter as cold remedies because they are associated with the loss of sense of smell (anosmia). Anosmia may be long-lasting or permanent. Source: www.fda.gov FDA Alerts Patients to Medtronic Pacemaker Recall The U.S. Food and Drug Administration is alerting patients to the Class I recall of certain Medtronic Kappa and Sigma pacemakers. These devices may fail due to a separation of wires that connect the electronic circuit to other pacemaker components, such as the battery. Source: www.fda.gov Testosterone gel products (AndroGel 1% and Testim 1% ) Testosterone gel products (AndroGel 1% and Testim 1% )
Boxed warning required to inform users of risk of unintended secondary exposure of children to testosterone. Source: www.fda.gov Tarceva (erlotinib) May 2009 Dear Healthcare Professional letter issued to warn about GI perforation, exfoliative skin conditions and corneal perforation/ulceration. Source: www.fda.gov Skin Products Made by Clarcon FDA notified consumers and healthcare professionals that Clarcon Biological Chemistry Laboratory is recalling some skin sanitizers and skin protectants because of high levels of disease-causing bacteria found in the product. During an FDA inspection, analyses of samples of several of these products revealed high levels of various bacteria, including some associated with unsanitary conditions. Some of these bacteria can cause opportunistic infections of the skin and underlying tissues. Such infections may need medical or surgical attention, and may result in permanent damage. These findings are particularly concerning because the products are promoted as antimicrobial agents that claim to treat open wounds, damaged skin, and protect against various infectious diseases. FDA is warning consumers to not use any Clarcon products and should throw these products away in household refuse. Source: www.fda.gov Sirolimus (marketed as Rapamune) FDA notified healthcare professionals of clinical trial data that suggest increased mortality in stable liver transplant patients after conversion from a calcineurin inhibitor (CNI)-based immunosuppressive regimen to sirolimus (Rapamune). The trial was conducted by sirolimus manufacturer, Wyeth. The Agency will continue to examine the data on mortality and other adverse events in this study, and will make further recommendations, as appropriate. The FDA is determining whether a labeling change for sirolimus is needed. In the interim, physicians should continue to use the drug’s professional labeling as a guide to therapy. See the FDA Healthcare Professional Information sheet for current FDA recommendations. Source: www.fda.gov Fun Express Water-based Face Paints for Children UPDATE - Fun Express expanded its recall of face paint items to include two additional face paint colors, 85/2338 (White face paint) and 85/2339 (Yellow face paint) Source: www.fda.gov Simponi (golimumab) Risk of serious fungal infections associated with TNF-α blockers, including Simponi (golimumab). Posted 05/28/2009 Source: www.fda.gov Recalls and Safety Alerts: Recall of Zencore Plus Bodee LLC is recalling its supplement product called Zencore Plus after FDA laboratory analysis showed that the product contains benzamidenafil. This is a newly discovered PDE5 inhibitor that is likely to have the same pharmacologic properties as si... Source: www.accessdata.fda.gov Stimulant Medications used in Children with Attention-Deficit/Hyperactivity Disorder - Communication about an Ongoing Safety Review FDA provides its perspective on study data published in the American Journal of Psychiatry on the potential risks of stimulant medications used to treat Attention-Deficit/Hyperactivity Disorder in children. The study authors concluded that there may be an association between the use of stimulant medications and sudden death in healthy children. Source: www.fda.gov Antiepileptic Drugs Source: www.fda.gov June 16, 2009U.S. Attorney News Release: Robert McFadden Palms Springs Attorney Sentenced for Prescription Drug Diversion U.S. Attorney News Release: Robert McFadden Palms Springs Attorney Sentenced for Prescription Drug Diversion
This press release is not being maintained on the FDA site. View the PDF version of this press announcement now. Source: www.fda.gov Digoxin, USP 0.125 mg, Digoxin, USP 0.25 mg (Caraco brand) Digoxin, USP 0.125 mg, Digoxin, USP 0.25 mg (Caraco brand)
Source: www.fda.gov Medtronic Kappa Series 600/700/900, Sigma Series 100/200/300 Pacemakers Class I recall of certain Kappa and Sigma Series pacemakers, because these devices may fail due to a separation of wires that connect the electronic circuit to other pacemaker components. Source: www.fda.gov November 2008 MedWatch November 2008 Drug Safety Labeling Changes Source: www.fda.gov January 2009 January 2009
January 2009 Drug Safety Labeling Changes Source: www.fda.gov Medtronic Kappa Series 600/700/900, Sigma Series 100/200/300 Pacemakers Class I recall of certain Kappa and Sigma Series pacemakers, because these devices may fail due to a separation of wires that connect the electronic circuit to other pacemaker components. Source: www.fda.gov Ceftriaxone (marketed as Rocephin and generics) Ceftriaxone (marketed as Rocephin and generics) Source: www.fda.gov Tri-State Hospital Supply Corporation, Centurion Brand Trays and Kits Tri-State Hospital Supply Corporation, Centurion Brand Trays and Kits Source: www.fda.gov Antiepileptic Drugs Source: www.fda.gov Recalls and Safety Alerts: Zoll AED Plus Defibrillator Recalled The device company Zoll Medical Corporation is recalling AED Plus Defibrillators that were manufactured between May 2004 and February 2009. Some of the batteries in these devices may not work properly, and the original self-test software cannot adeq... Source: www.accessdata.fda.gov Advice for Patients: Help Patients Use Acetaminophen Safely Acetaminophen toxicity is a leading cause of acute liver failure, resulting in an estimated 400 deaths in this country each year. Many of these events are happening because patients are unknowingly taking too much of the drug. Several factors co... Source: www.accessdata.fda.gov Leukotriene Inhibitors: Montelukast (marketed as Singulair), Zafirlukast (marketed as Accolate), and Zileuton (marketed as Zyflo and Zyflo CR) FDA provided healthcare professionals with updated information on the original March 2008 early communication and January 2009 follow-up communcation about the ongoing safety review for the Leukotriene inhibitors, montelukast, zafirlukast and zileuton. Neuropsychiatric events have been reported in some patients taking montelukast (Singulair), zafirlukast (Accolate), and zileuton (Zyflo and Zyflo CR). FDA has requested that manufacturers include a precaution in the drug prescribing information (drug labeling). The reported neuropsychiatric events include postmarket cases of agitation, aggression, anxiousness, dream abnormalities and hallucinations, depression, insomnia, irritability, restlessness, suicidal thinking and behavior (including suicide), and tremor. Source: www.fda.gov Recalls and Safety Alerts: Recalls of Digoxin and Propafenone Tablets FDA has posted information about two cardiac drugs that were recently recalled because of variability in the size of the tablets: ? Caraco Pharmaceutical Laboratories, a manufacturer of generic pharmaceuticals, recalled some of their digoxin table... Source: www.accessdata.fda.gov FDA Consumer Corner: Don?t Overdo It with Acetaminophen If you woke up with a headache this morning, you may have reached for an over-the-counter pain reliever. Millions of people do that everyday, and there's usually no problem. Over-the-counter pain relievers are effective for treating minor aches and... Source: www.accessdata.fda.gov FDA Approves Injectable Form of Ibuprofen FDA Approves Injectable Form of Ibuprofen
The U.S. Food and Drug Administration today approved Caldolor, the first injectable dosage form of the common pain medication ibuprofen, to treat pain and fever. Source: www.fda.gov Propylthiouracil Propylthiouracil (PTU)-Induced Liver Failure Source: www.fda.gov Simponi (golimumab) Risk of serious fungal infections associated with TNF-α blockers, including Simponi (golimumab). Posted 05/28/2009 Source: www.fda.gov November 2008 MedWatch November 2008 Drug Safety Labeling Changes Source: www.fda.gov Levemir Insulin (Novo Nordisk) Patients advised to check personal supply of insulin to identify possible stolen and dangerous product. Source: www.fda.gov Sirolimus (marketed as Rapamune) FDA notified healthcare professionals of clinical trial data that suggest increased mortality in stable liver transplant patients after conversion from a calcineurin inhibitor (CNI)-based immunosuppressive regimen to sirolimus (Rapamune). The trial was conducted by sirolimus manufacturer, Wyeth. The Agency will continue to examine the data on mortality and other adverse events in this study, and will make further recommendations, as appropriate. The FDA is determining whether a labeling change for sirolimus is needed. In the interim, physicians should continue to use the drug’s professional labeling as a guide to therapy. See the FDA Healthcare Professional Information sheet for current FDA recommendations. Source: www.fda.gov June 15, 2009Recalls and Safety Alerts: Recall of Medtronic Ventricular Snap Shunt Catheters Recalls and Safety Alerts: Recall of Medtronic Ventricular Snap Shunt Catheters
Medtronic Neurologic Technologies has recalled the company's Bioglide Ventricular Snap Shunt Catheter, which is a component of a shunt system that is used to treat hydrocephalus. The catheters may become detached from the snap base assembly, and tha... Source: www.accessdata.fda.gov Medtronic Kappa Series 600/700/900, Sigma Series 100/200/300 Pacemakers Class I recall of certain Kappa and Sigma Series pacemakers, because these devices may fail due to a separation of wires that connect the electronic circuit to other pacemaker components. Source: www.fda.gov Tarceva (erlotinib) May 2009 Dear Healthcare Professional letter issued to warn about GI perforation, exfoliative skin conditions and corneal perforation/ulceration. Source: www.fda.gov Recalls and Safety Alerts: Raptiva Withdrawn from the Market Genentech is conducting a phased market withdrawal of the psoriasis drug Raptiva (efalizumab). The company is doing this because taking the drug carries the risk of developing progressive multifocal leukoencephalopathy (PML). PML, which is caused by... Source: www.accessdata.fda.gov Fun Express Water-based Face Paints for Children UPDATE - Fun Express expanded its recall of face paint items to include two additional face paint colors, 85/2338 (White face paint) and 85/2339 (Yellow face paint) Source: www.fda.gov Sirolimus (marketed as Rapamune) FDA notified healthcare professionals of clinical trial data that suggest increased mortality in stable liver transplant patients after conversion from a calcineurin inhibitor (CNI)-based immunosuppressive regimen to sirolimus (Rapamune). The trial was conducted by sirolimus manufacturer, Wyeth. The Agency will continue to examine the data on mortality and other adverse events in this study, and will make further recommendations, as appropriate. The FDA is determining whether a labeling change for sirolimus is needed. In the interim, physicians should continue to use the drug’s professional labeling as a guide to therapy. See the FDA Healthcare Professional Information sheet for current FDA recommendations. Source: www.fda.gov Tri-State Hospital Supply Corporation, Centurion Brand Trays and Kits Tri-State Hospital Supply Corporation, Centurion Brand Trays and Kits Source: www.fda.gov November 2008 MedWatch November 2008 Drug Safety Labeling Changes Source: www.fda.gov Giving Medication to Children Giving Medication to Children
The director of FDA's Office of Pediatric Therapeutics discusses what parents should know about medication use in children. Source: www.fda.gov Recalls and Safety Alerts: Raptiva Withdrawn from the Market Genentech is conducting a phased market withdrawal of the psoriasis drug Raptiva (efalizumab). The company is doing this because taking the drug carries the risk of developing progressive multifocal leukoencephalopathy (PML). PML, which is caused by... Source: www.accessdata.fda.gov Warning on Hydroxycut Products FDA is warning consumers to stop using Hydroxycut products because of serious health risks. One death due to liver failure has been reported to the agency. Source: www.fda.gov FDA Promotes Openness and Transparency to Public FDA is working to make useful information about FDA activities and decision making more readily available to the public. Source: www.fda.gov FDA: First Drug to Treat Cancer in Dogs Approved FDA: First Drug to Treat Cancer in Dogs Approved
The U.S. Food and Drug Administration today announced the approval of Palladia (toceranib phosphate), the first drug developed specifically for the treatment of cancer in dogs. Source: www.fda.gov FDA Alerts Consumers to Recall of Water-Based Face Paints The Food and Drug Administration is advising consumers to stop using certain cosmetic “Face Paint” items labeled as distributed by Oriental Trading Co., Omaha, Neb., due to adverse event reports of skin reactions in children. These items were distributed nationwide. Source: www.fda.gov FDA Warns Consumers Not to Use Skin Products Made by Clarcon Due to Bacterial Contamination Risk The U.S. Food and Drug Administration announced today that Clarcon Biological Chemistry Laboratory Inc. of Roy, Utah, is voluntarily recalling some skin sanitizers and skin protectants marketed under several different brand names because of high levels of disease-causing bacteria found in the product during a recent inspection. The FDA is warning consumers to not use any Clarcon products. Source: www.fda.gov U.S. Attorney News Release: California Man Sentenced for Prescription Drug Diversion CONCORD, NEW HAMPSHIRE: Thomas Lavery, of Irvine, CA, was sentenced to 52 months of incarceration to be followed by three years of supervised release for illegally distributing large quantities of Serostim, an HIV drug, which were illegally purchased from illegitimate sources and then illegally sold to wholesale distributors in various parts of the country, using falsified paperwork. Judge McAuliffe also entered an order of forfeiture against Lavery for the sum of $1,009,460. Source: www.fda.gov FDA Warns Consumers to Stop Using Hydroxycut Products The U.S. Food and Drug Administration is warning consumers to immediately stop using Hydroxycut products by Iovate Health Sciences Inc., of Oakville, Ontario and distributed by Iovate Health Sciences USA Inc. of Blasdell, N.Y. Some Hydroxycut products are associated with a number of serious liver injuries. Iovate has agreed to recall Hydroxycut products from the market. Source: www.fda.gov June 14, 2009Influend Cough and Cold Products Influend Cough and Cold Products
Influend Cough and Cold Products Source: www.fda.gov January 2009 January 2009 Drug Safety Labeling Changes Source: www.fda.gov Medtronic Kappa Series 600/700/900, Sigma Series 100/200/300 Pacemakers Class I recall of certain Kappa and Sigma Series pacemakers, because these devices may fail due to a separation of wires that connect the electronic circuit to other pacemaker components. Source: www.fda.gov Recalls and Safety Alerts: Raptiva Withdrawn from the Market Genentech is conducting a phased market withdrawal of the psoriasis drug Raptiva (efalizumab). The company is doing this because taking the drug carries the risk of developing progressive multifocal leukoencephalopathy (PML). PML, which is caused by... Source: www.accessdata.fda.gov Tri-State Hospital Supply Corporation, Centurion Brand Trays and Kits Tri-State Hospital Supply Corporation, Centurion Brand Trays and Kits Source: www.fda.gov Biosite brand Triage Cardiac Panel Use of affected lots of the Triage Cardiac Panel may lead to false negative results, possibly resulting in missed or incorrect diagnosis. Source: www.fda.gov Recalls and Safety Alerts: Recall of Medtronic Ventricular Snap Shunt Catheters Medtronic Neurologic Technologies has recalled the company's Bioglide Ventricular Snap Shunt Catheter, which is a component of a shunt system that is used to treat hydrocephalus. The catheters may become detached from the snap base assembly, and tha... Source: www.accessdata.fda.gov Simponi (golimumab) Risk of serious fungal infections associated with TNF-α blockers, including Simponi (golimumab). Posted 05/28/2009 Source: www.fda.gov Ceftriaxone (marketed as Rocephin and generics) Ceftriaxone (marketed as Rocephin and generics) Source: www.fda.gov Leukotriene Inhibitors: Montelukast (marketed as Singulair), Zafirlukast (marketed as Accolate), and Zileuton (marketed as Zyflo and Zyflo CR) FDA provided healthcare professionals with updated information on the original March 2008 early communication and January 2009 follow-up communcation about the ongoing safety review for the Leukotriene inhibitors, montelukast, zafirlukast and zileuton. Neuropsychiatric events have been reported in some patients taking montelukast (Singulair), zafirlukast (Accolate), and zileuton (Zyflo and Zyflo CR). FDA has requested that manufacturers include a precaution in the drug prescribing information (drug labeling). The reported neuropsychiatric events include postmarket cases of agitation, aggression, anxiousness, dream abnormalities and hallucinations, depression, insomnia, irritability, restlessness, suicidal thinking and behavior (including suicide), and tremor. Source: www.fda.gov FDA's MedWatch Safety Alerts: June 2009 FDA's MedWatch Safety Alerts: June 2009
FDA has issued recent safety alerts on these medical products. Source: www.fda.gov Leukotriene Inhibitors: Montelukast (marketed as Singulair), Zafirlukast (marketed as Accolate), and Zileuton (marketed as Zyflo and Zyflo CR) FDA provided healthcare professionals with updated information on the original March 2008 early communication and January 2009 follow-up communcation about the ongoing safety review for the Leukotriene inhibitors, montelukast, zafirlukast and zileuton. Neuropsychiatric events have been reported in some patients taking montelukast (Singulair), zafirlukast (Accolate), and zileuton (Zyflo and Zyflo CR). FDA has requested that manufacturers include a precaution in the drug prescribing information (drug labeling). The reported neuropsychiatric events include postmarket cases of agitation, aggression, anxiousness, dream abnormalities and hallucinations, depression, insomnia, irritability, restlessness, suicidal thinking and behavior (including suicide), and tremor. Source: www.fda.gov Safety Concerns and Labeling Changes for Psoriasis Drug Raptiva FDA has received reports of serious infections leading to hospitalizations and deaths in people who use Raptiva Source: www.fda.gov New Labeling Required for OTC Pain and Fever Medicines On April 28, 2009, FDA issued a final rule that requires manufacturers of over-the-counter (OTC) pain relievers and fever reducers to revise their labeling Source: www.fda.gov FDA: First Drug to Treat Cancer in Dogs Approved The U.S. Food and Drug Administration today announced the approval of Palladia (toceranib phosphate), the first drug developed specifically for the treatment of cancer in dogs. Source: www.fda.gov FDA 101: Animal Feed This primer describes how FDA regulates animal feed, including pet food. Source: www.fda.gov |
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