Safety Alerts & Recalls

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New FDA Warning on Seizure Medications
In a follow up to the safety review conducted earlier in 2008, the FDA will change the label for antiepileptic medications, such as { drug_name }, to include a warning that use of these medications increases the risk of suicidal thoughts and behaviors (suicidality). This new warning includes all antiepileptic drugs including those used to treat epilepsy as well as depression, bipolar depression, migraines, and other conditions. For more information please visit: http://www.fda.gov/cder/drug/advisory/antiepileptics.htm
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Ongoing FDA Safety Review of Stimulant Mediations Used to Treat ADHD in Children
A recent study published in American Journal of Psychiatry suggests there may be a link between the use of stimulant medications for attention-deficit hyperactivity disorder (also known as ADHD) and sudden cardiac death in healthy children. In the study, the investigators compared the use of stimulant medications in two groups of children in the United States: one group of 564 healthy children who died suddenly from unexplained heart related problems and one group of 564 children who died as passengers in a motor vehicle accident. According to the study report, 10 of the healthy children who died suddenly from unexplained heart problems, or 1.8% of the group, were reported to be taking a stimulant medication at the time of death. This compared with only two cases of stimulant use, or 0.4%, among healthy children who had died in motor vehicle accidents. At this time, the FDA is reviewing the results of the study and is unable to conclude that the results of the study affect the overall risk and benefit profile of stimulant medications used to treat ADHD in children. The FDA says that, because of the study's limitations, parents should not stop a child's stimulant medication based on the study. Prescription stimulant medications are used to treat ADHD, a continuous pattern of inattention and/or hyperactivity-impulsiveness that is more severe than expected for a child's developmental age. Examples of stimulant treatments for ADHD include: dexmethylphenidate (Focalin, Focalin XR), dextroamphetamine sulfate (Dexedrine, Dexedrine Spansules, Dextroamphetamine ER, Dextrostat), lisdexamfetamine (Vyvanse), methamphetamine (Desoxyn), methylphenidate (Concerta, Daytrana, Metadate CD, Metadate ER, Methylin, Methylin ER, Ritalin, Ritalin-LA, Ritalin-SR), mixed salts amphetamine (Adderall, Adderall XR), pemoline (Cylert), and generics. For more information, please visit: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm166667.htm
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Date Published Title Drug Source
2008-12-17 New FDA Warning on Seizure Medications Mesuximide FDA
2009-06-16 Ongoing FDA Safety Review of Stimulant Mediations Used to Treat ADHD in Children FDA
2010-04-15 Asthma and COPD Inhalers That Contain Ozone-depleting CFCs to be Phased Out; Alternative Treatments Available Metaproterenol FDA
2008-09-18 FDA Stops Imports of Ranbaxy Products Metformin FDA
2010-07-21 Glumetza: Depomed Inc. Recalls Several Lots Metformin FDA
2011-04-25 Mylan Pharmaceuticals Inc. Recalls Several Lots of Metformin Metformin FDA
2011-05-20 Teva Pharmaceuticals Recalls Single Lot of Metformin Hydrochloride Tablets, USP 500 mg Metformin FDA
2011-06-01 Sandoz Inc. Recalls Single Lot of Metformin Hydrochloride Tablets 1000 mg Metformin FDA
2012-01-04 Alkem Laboratories Recalls Several Lots of Metformin Hydrochloride, Tablets USP, 850 mg and 1000 mg Metformin FDA
2009-09-25 New Information About Reports of Acute Pancreatitis in Patients Using Sitagliptan (Januvia, Janumet) Metformin and Sitagliptin FDA
2007-08-14 Some Diabetes Drugs to Strengthen Warning on Heart Failure Risk Metformin with Rosiglitazone FDA
2007-11-14 New additions to black box warning Metformin with Rosiglitazone FDA
2009-06-08 Thiazolidinediones Associated with Increased Risk of Fractures Metformin with Rosiglitazone MediGuard CRT
2009-04-30 New Guide for Using Methadone Safely Methadone FDA
2011-04-20 FDA Announces New Program for Long-Acting and Extended-Release Opioids Methadone FDA
2012-07-10 FDA Approves Safety Program to Reduce Risk of Opioid Pain Relievers Methadone FDA
2008-08-04 Generic Manufacturer Recalls Several Drug Products Methenamine Manufacturer
2010-10-29 Sandoz Issues Voluntary Recall of Methotrexate Injection Vials Methotrexate Manufacturer
2012-09-14 FDA Warns OTC Topical Pain Relievers May Cause Burns to Skin Methyl Salicylate FDA
2012-07-22 Bausch & Lomb, Inc. Recalls Several Lots of Murocel Lubricant Eye Drops Methylcellulose FDA
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