Safety Alerts & Recalls

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Reducing Fever and Relieving Pain in Children: Safe Use of Acetaminophen
The U.S. Food and Drug Administration (FDA) recently published a consumer webpage to inform parents and caregivers about the safe use of acetaminophen in children. Sold as a single active ingredient under such brand names as Tylenol, acetaminophen is commonly used to reduce fever and relieve pain. Improper dosing is one of the biggest problems in giving acetaminophen to children. If you give a child even a little more than directed or give more than one medicine that contains acetaminophen, it can cause side effects such as nausea and vomiting. In some cases, in both adults and children, too much acetaminophen can cause liver failure. Confusion about dosing is partly caused by the availability of different formulas, strengths, and dosage instructions for different ages of children. Acetaminophen can be found in more than 600 over-the-counter (OTC, or non-prescription) and prescription medicines. For more information, please visit: http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm263989.htm
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FDA Reviewing Results of Study Multaq (Dronedarone) in Patients with Permanent Atrial Fibrillation
Severe side effects have been detected in a large clinical study of the drug Multaq (dronedarone). This led the manufacturer Sanofi Aventis to the stop the study early. In the study called Permanent Atrial fibriLLAtion Outcome Study Using Dronedarone on Top of Standard Therapy (PALLAS), dronedarone was given to patients with permanent atrial fibrillation, an abnormal rhythm of the heart. Patients who received the drug had a higher risk for severe cardiovascular events including stroke and heart attack than patients who received placebo. Currently Multaq is only approved for use in patients with non-permanent atrial fibrillation (also known as paroxysmal or persistent atrial fibrillation), a different, but related patient population of the PALLAS study. The U.S. Food and Drug Administration (FDA) is reviewing the results of the PALLAS study to determine whether and how the results of the PALLAS study, apply to patients who use Multaq for the approved indications (non-permanent atrial fibrillation). For more information please visit: http://www.fda.gov/Drugs/DrugSafety/ucm264059.htm
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Date Published Title Drug Source
2011-07-22 Reducing Fever and Relieving Pain in Children: Safe Use of Acetaminophen Acetaminophen FDA
2011-07-22 FDA Reviewing Results of Study Multaq (Dronedarone) in Patients with Permanent Atrial Fibrillation Dronedarone FDA
2011-07-22 FDA Reviewing of Oral Bisphosphonates and Potential Increased Risk of Esophageal Cancer Ibandronate Sodium FDA
2011-07-21 Non-Safety-Related Recall of Several Lots of Daytrana Patches Methylphenidate Manufacturer
2011-07-19 D.S.C. Laboratories Recalls Single Lot of Anecream Lidocaine 4% Cream Lidocaine FDA
2011-07-19 Teva Recalls Several Lots of Prazosin Capsules, 1 mg Prazosin FDA
2011-07-19 King Pharmaceuticals Recalls Single Lot of Cortisporin Otic Solution Otosporin FDA
2011-07-19 Bayer Health Recalls Single Lot of Genuine Bayer Aspirin Aspirin FDA
2011-07-19 Teva Recalls Several Lots of Hydralazine Tablets, 10 mg, 25 mg, 50 mg and 100 mg Hydralazine FDA
2011-07-19 Pfizer Recalls Select Lots of Nitrostat (Nitroglycerin) Tablets, 0.4mg Nitroglycerin FDA
2011-07-19 Drug Interaction Warnings Added to Prescribing Information for Seroquel Quetiapine FDA
2011-07-13 CDC Revises Recommendations for the Use of Birth Control Methods During the Initial Period After Childbirth MediGuard CRT
2011-07-12 Fetal Exposure To Valproate Medicine During Pregnancy May Cause Cognitive Delay Divalproex Sodium FDA
2011-07-07 Chantix: New Study Links Drug to Heart Problems Varenicline MediGuard CRT
2011-06-30 New Study Suggests High-Dose Statins May Cause Diabetes Simvastatin MediGuard CRT
2011-06-30 McNeil Recalls Single Lot of Tylenol Extra Strength Caplets, 225 count Acetaminophen Manufacturer
2011-06-28 Qualitest Recalls Four Lots of Butalbital, Acetaminophen, and Caffeine Tablets and Four Lots of Hydrocodone Bitartrate and Acetaminophen Tablets Butalbital FDA
2011-06-27 Endo Pharmaceuticals Recalls Endocet Bottles With Wrong Pill Sizes Acetaminophen with Oxycodone Manufacturer
2011-06-27 Rugby Recalls Children's Pain & Fever Concentrated Drops Due To Problems With Child-Resistant Closure Acetaminophen Manufacturer
2011-06-24 FDA Modifies Dosing Recommendations for Erythropoiesis-Stimulating Agents Epoetin Alfa FDA