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FDA Warns: Abnormal Heart Rhythms May Be Associated with Use of High Dose Zofran (Ondansetron)
The U.S. Food and Drug Administration (FDA) has informed healthcare professionals that early results from a recently completed clinical study suggest that a 32 mg single intravenous dose of ondansetron (Zofran) may affect the electrical activity of the heart (QT interval prolongation), which could increase a patients risk of developing an abnormal and potentially fatal heart rhythm known as Torsades de Pointes. Zofran and its generics (ondansetron) are used to prevent nausea and vomiting caused by cancer chemotherapy, radiation therapy and surgery. GlaxoSmithKline (GSK) has announced changes to the Zofran drug label to remove the 32 mg single intravenous dose. The updated label will state that ondansetron can continue to be used in adults and children with chemotherapy-induced nausea and vomiting at the lower intravenous dose, a dose of 0.15 mg/kg administered every 4 hours for three doses; however, no single intravenous dose should exceed 16 mg. Information from the new clinical study will be included in the updated drug label. As part of the ongoing safety review of ondansetron, the FDA continues to assess data about the risk of QT prolongation and will update the public when more information becomes available. For more information, please visit: http://www.fda.gov/Drugs/DrugSafety/ucm310190.htm
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FDA Issues Drug Safety Communication about the Risk of Seizures with Ampyra (Dalfampridine)
The U.S. Food and Drug Administration (FDA) is updating health care professionals and the public about the risk of seizures in patients with multiple sclerosis (MS) who are starting Ampyra (dalfampridine). Using information received from post-market adverse event reports, FDA recently evaluated seizure risk in MS patients taking Ampyra (dalfampridine). The majority of seizures happened within days to weeks after starting the recommended dose and occurred in patients having no history of seizures. Seizures are a known side effect of Ampyra, and seizure risk increases with higher blood levels of the drug. Ampyra is eliminated from the body through the kidneys, and patients with kidney impairment may develop higher blood levels of the drug, thereby increasing their seizure risk. The FDA is also updating the Ampyra prescribing information to clarify recommendations that kidney function should be checked in patients before starting Ampyra and monitored at least annually while Ampyra treatment continues. Additionally, patients who miss a dose should not take extra doses — an extra dose of Ampyra can increase seizure risk. Ampyra contains the active ingredient dalfampridine and is used to improve walking in patients with MS. For more information, please visit: http://www.fda.gov/Drugs/DrugSafety/ucm312846.htm
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Date Published Title Drug Source
2012-07-24 FDA Warns: Abnormal Heart Rhythms May Be Associated with Use of High Dose Zofran (Ondansetron) Ondansetron FDA
2012-07-23 FDA Issues Drug Safety Communication about the Risk of Seizures with Ampyra (Dalfampridine) Dalfampridine FDA
2012-07-23 Teva Pharmaceuticals USA Recalls Several Lots of Zeosa Norethindrone / Ethinyl Estradiol / Ferrous Fumarate FDA
2012-07-23 Teva Pharmaceuticals USA, Inc. Recalls Several Lots of Atenolol Tablets, 25 mg Atenolol FDA
2012-07-22 Physicians Total Care, Inc Recalls Several Lots of Arthrotec 75 Diclofenac Sodium with Misoprostol FDA
2012-07-22 Bausch & Lomb, Inc. Recalls Several Lots of Murocel Lubricant Eye Drops Methylcellulose FDA
2012-07-22 Noven Pharmaceutical Recalls Several Lots of Daytrana Patches Methylphenidate FDA
2012-07-22 Endo Pharmaceuticals Recalls One Lot of Endocet Tablets, 10 mg/650 mg Acetaminophen with Oxycodone FDA
2012-07-22 Dermallogix Partners Recalls Single Lot of DermaZinc Spray, 0.25% zinc pyritione Dermazinc FDA
2012-07-20 Mylan Pharmaceuticals Inc Recalls Single Lot of Alprazolam Extended-release Tablets, 2 mg Alprazolam FDA
2012-07-20 Ortho-McNeil-Janssen Pharmaceuticals, Inc. Recalls Single Lot of Duragesic 25 mcg/h Fentanyl FDA
2012-07-20 Mallinckrodt Inc. Recalls Several Lots of Methylin Chewable Tablets (methylphenidate HCl) 2.5 mg, 5 mg and 10 mg Methylphenidate FDA
2012-07-19 Shionogi Inc. Recalls Single Lot of Nisoldipine Extended Release Tablets, 17mg Nisoldipine FDA
2012-07-19 Teva Pharmaceuticals Recalls Single Lot of Mefloquine Tablets, 250 mg Mefloquine FDA
2012-07-19 Lloyd Pharmaceutical Recalls Select Lots of Levothroid 50 mcg and 75 mcg Tablets Levothyroxine FDA
2012-07-19 Watson Laboratories Recalls Several Lots of Loxapine Capsules Loxapine FDA
2012-07-19 Ranbaxy Recalls Single Lot of Balnetar Therapeutic Tar Bath, Coal Tar 2.5% FDA
2012-07-19 TEVA Phamaceuticals Recalls Single Lot of Metoprolol Tartrate Tablets 50 mg Metoprolol FDA
2012-07-10 FDA Approves Safety Program to Reduce Risk of Opioid Pain Relievers Oxymorphone FDA
2012-07-10 FDA Approves Safety Program to Reduce Risk of Opioid Pain Relievers Methadone FDA