Safety Alerts & Recalls

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FDA Publishes Results of Safety Review Update of Chantix and Risk of Heart Attack and Stroke
The U.S. Food and Drug Administration (FDA) is informing the public about the results of a large, combined analysis (called a meta-analysis) of clinical studies that compared patients who received the smoking cessation drug Chantix (varenicline) to patients who received a placebo (an inactive treatment or sugar pill). Patients using Chantix experienced a higher rate of major adverse cardiovascular related events (a combined outcome of cardiovascular-related death, non-fatal heart attack, and nonfatal stroke) than patients who received a placebo pill. However, these serious adverse events were rare in both the Chantix and placebo groups, and the increased risk was not statistically significant, which means it is uncertain whether the excess risk for the Chantix group was due to taking the drug or due to chance. Chantix is a prescription medicine used to help adults quit smoking that works by blocking the effects of nicotine (from smoking) on the brain. For more information, please visit: http://www.fda.gov/Drugs/DrugSafety/ucm330367.htm
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New Antidepressant Guide for Patients
The FDA has published a patient guide titled "Understanding Antidepressant Medications." For more information, please visit: http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm095980.htm
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Date Published Title Drug Source
2012-12-12 FDA Publishes Results of Safety Review Update of Chantix and Risk of Heart Attack and Stroke Varenicline FDA
2009-01-12 New Antidepressant Guide for Patients Venlafaxine FDA
2010-03-02 Wyeth Recalls Several Lots of Effexor XR 37.5 mg, 75 mg, and 150 mg Capsules Venlafaxine FDA
2012-11-27 Stat Rx USA, LLC Recalls a Single Lot of Venlafaxine ER 150mg Tablets Venlafaxine FDA
2014-03-07 Pfizer Recalls Some Lots of Antidepressant Effexor Venlafaxine Manufacturer
2009-05-04 Recall on Single lot of Calan (Verapamil) 80 mg tablets Verapamil FDA
2012-01-04 Mylan Pharmaceuticals Inc. Recalls Single Lot of Verapamil HCI Extended-Release Capsules, 180 mg Verapamil FDA
2009-12-21 Recall on Vicks DayQuil Cold & Flu Vicks Dayquil Manufacturer
2010-07-28 Bausch + Lomb Recalls PreserVision Eye Vitamin AREDS 2 Formula with Omega 3 Soft Gel VIT A / VIT C / VIT E / Copper / Zinc Manufacturer
2013-07-29 FDA Warns: Healthy Life Chemistry By Purity First B-50 Contains Possibly Harmful Anabolic Steroids Vitamin B Complex FDA
2013-08-05 FDA Warns: Purity First’s Expands Recall and Now Includes Healthy Life Chemistry B-50, Vitamin C and Multi-Mineral Vitamin B Complex FDA
2011-10-17 Study Links High Doses of Vitamin E to Possible Increase in Prostate Cancer Risk Vitamin E MediGuard CRT
2008-08-05 Generic Manufacturer Recalls Several Drug Products Vitamin K Manufacturer
2008-08-05 Generic Manufacturer Recalls Several Drug Products Vitaplex Manufacturer
2008-08-05 Generic Manufacturer Recalls Several Drug Products Vitaplex Comp Manufacturer
2008-07-03 New Consumer Guide for Patients Warfarin MediGuard CRT
2008-12-12 Blood Thinner Warfarin (Coumadin) Has New Brand Competition Warfarin ISMP
2009-06-08 Kidney Function May Affect Warfarin Dose Warfarin MediGuard CRT
2010-07-06 Bristol-Myers Recalls Coumadin Blister Pack Samples Warfarin Manufacturer
2011-02-18 Upsher-Smith Announces Nationwide Recall Of Jantoven Warfarin Sodium Tablets, 3mg, Due To Mislabeled Bottles Warfarin FDA
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