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FDA Warns: Abnormal Heart Rhythms May Be Associated with Use of Zofran (Ondansetron)
The U.S. Food and Drug Administration (FDA) is conducting an ongoing safety review of the anti-nausea drug Zofran (ondansetron) and its generics. Ondansetron may increase the risk of developing abnormal changes in the electrical activity of the heart called QT prolongation. This abnormal change in the electrical activity of the heart can result in a serious and potentially fatal abnormal heart rhythm. The FDA has reviewed all available information to date and is making changes to the prescribing information of Zofran and its generics to include a warning to healthcare providers to avoid use of this medicine in patients with the heart condition called congenital long QT syndrome because these patients are at particular risk for abnormal hearth rhythms. Additionally, healthcare providers have been advised to monitor heart rates and rhythms by regularly performing an electrocardiogram (ECG, EKG) in patients taking Zofran or ondansetran who are at higher risk due to: having electrolyte abnormalities (such as low potassium or low magnesium levels in the blood called hypokalemia), having congestive heart failure (CHF), having a slow heart rate, or taking other medications that can lead to abnormal changes in the electrical activity of the heart. As part of the review, the manufacturer of Zofran (GlaxoSmithKline) is required to conduct a study to assess the potential for the drug to cause abnormal changes in the electrical activity of the heart. The FDA will update the public as new information becomes available from this study. Zofran (ondansetron) and its generics are used to prevent nausea and vomiting caused by cancer chemotherapy, radiation therapy and surgery. For more information, please visit: http://www.fda.gov/Drugs/DrugSafety/ucm271913.htm
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Pure Encapsulations, Incorporated Recalls Prenatal Nutrients Products
Pure Encapsulations, Incorporated has recalled their prenatal product PreNatal Nutrients. The recall was made because the product may contain egg, an undeclared allergen. 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. The recall includes PreNatal Nutrients 60-count bottles and 120-count bottles. The recalled lot numbers are 3560111B or 3560111 A with a ‘best by’ date of January 2013. PreNatal Nutrients was distributed nationwide through healthcare providers. For more information, please visit: http://www.fda.gov/Safety/Recalls/ucm270430.htm
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Date Published Title Drug Source
2011-09-16 FDA Warns: Abnormal Heart Rhythms May Be Associated with Use of Zofran (Ondansetron) Ondansetron FDA
2011-09-08 Pure Encapsulations, Incorporated Recalls Prenatal Nutrients Products Prenatal Vitamins FDA
2011-09-07 FDA Updates Labels for Remicade (infliximab), Enbrel (etanercept), Humira (adalimumab), Cimzia (certolizumab pegol), and Simponi (golimumab) Etanercept FDA
2011-09-07 FDA Warns of Infection Risk from Repackaged Avastin Injections For Eye Disease Bevacizumab FDA
2011-09-01 FDA Warns: Serious Allergic Reactions Reported with the Use of Saphris (Asenapine Maleate) Asenapine FDA
2011-09-01 FDA Adds Warning of Risk of Kidney Failure With Use of Reclast (Zoledronic Acid) Zoledronic Acid FDA
2011-08-27 Abnormal Heart Rhythms Associated with High Doses of Citalopram (Celexa) Citalopram FDA
2011-08-16 McNeil Recalls Tylenol Cold Multi-Symptom Nighttime Rapid Release Gelcaps Tylenol Cold Multisymtom Plus Coug Manufacturer
2011-08-16 Taro Pharmaceuticals Recalls Select Lots of Fluorouracil Topical Cream, 5% Fluorouracil FDA
2011-08-16 Dr. Reddy's Laboratories Inc. Recalls Simvastatin Tablets Due To Musty Smell Simvastatin FDA
2011-08-16 Teva Pharmaceuticals Recalls Several Lots of Risperidone 0.25 mg, 0.5 mg, 1 mg, 2 mg and 3 mg Tablets Risperidone FDA
2011-08-16 Kimberly-Clark Corp. Recalls Several Lots of KimVent Oral Care Kits with Chlorhexidine Gluconate Solution 0.12% Chlorhexidine FDA
2011-08-16 Hi-Tech Pharmacal Recalls Single Lot of Chlorhexidine Gluconate Oral Rinse, 0.12% Chlorhexidine FDA
2011-08-16 Novartis Pharmaceuticals Recalls Single Lot of Enablex Darifenacin FDA
2011-08-16 Corepharma Recalls Several Lots of Potassium Citrate Extended-Release Tablets Potassium Citrate FDA
2011-08-05 FDA Updates Safety Review For Recombinant Human Growth Hormone (Somatropin) Somatropin FDA
2011-08-03 FDA Warns: Risk of Birth Defect with Long-Term, High-Dose Fluconazole During Pregnancy Fluconazole FDA
2011-08-03 Hetero Drugs Limited Recalls Single Lot of Torsemide tablets, 100 mg Torsemide FDA
2011-08-03 Vintage Pharmaceuticals Recalls Single Lot of Q-Tapp DM Liquid Poly-Histine-DM FDA
2011-08-03 Vintage Pharmaceuticals Recalls Select Lots of CODITUSS DM Liquid FDA
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