Safety Alerts & Recalls

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Latest Alerts

Sprycel Linked To Raised Blood Pressure In The Lungs
The Food and Drug Administration (FDA) has alerted healthcare professionals that Sprycel (dasatinib) may increase the risk of a rare but serious condition called Pulmonary Arterial Hypertension (PAH). PAH is a condition of abnormally high blood pressure in the arteries of the lungs and can lead to heart failure. Symptoms of PAH may include shortness of breath, fatigue, and swelling of the body (such as the ankles and legs). In reported cases, patients developed PAH after starting Sprycel, including some cases of PAH that developed after more than one year of treatment with Sprycel. Patients should be evaluated for signs and symptoms of heart and lung disease prior to starting Sprycel and during treatment. Information about this risk has been added to the Warnings and Precautions section of the Sprycel drug label. Sprycel which contains the drug dasatinib is used in the treatment of certain types of leukemia in adults. For more information please visit: http://www.fda.gov/Drugs/DrugSafety/ucm275155.htm
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Study Links High Doses of Vitamin E to Possible Increase in Prostate Cancer Risk
A recently published study in the Journal of the American Medical Association is raising concerns about excessive use of vitamins, specifically Vitamin E. According to this large federal study, large daily doses of Vitamin E may increase the risk for prostate cancer among middle-aged men. This study adds to the growing number studies highlighting concerns about the long-term use of high dose vitamin and mineral supplements by people who do not have severe nutritional deficiencies. For more information, please visit: http://jama.ama-assn.org/content/306/14/1549.short
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Date Published Title Drug Source
2011-10-11 Sprycel Linked To Raised Blood Pressure In The Lungs Dasatinib FDA
2011-10-17 Study Links High Doses of Vitamin E to Possible Increase in Prostate Cancer Risk Vitamin E MediGuard CRT
2011-10-18 Study Links Vitamins to Increased Risk Of Death In Older Women Zinc MediGuard CRT
2011-10-20 Sanofi-Aventis Announces Shortage of Apidra SoloSTAR Pens Insulin Glulisine Manufacturer
2011-10-21 FDA Updates Information about the Drug Interaction Between Linezolid (Zyvox) and Certain Certain Medicines for Depression, Anxiety, Bipolar Disorder, Insomnia Linezolid FDA
2011-10-21 FDA Updates Information about the Drug Interaction Between Methylene Blue and Certain Certain Medicines for Depression, Anxiety, Bipolar Disorder, Insomnia Methylene Blue FDA
2011-10-22 Nostrilla Nasal Decongestant: Recall due to Bacterial Contamination Oxymetazoline Manufacturer
2011-10-24 FDA Issues Safety Review Update on Chantix and Mental Health Adverse Effects Varenicline FDA
2011-10-25 FDA: Xigris [drotrecogin alfa (activated)] Withdrawn From Market Due to Failure to Show Benefit FDA
2011-10-27 FDA Continues Review of the Risk of Blood Clots in Women Taking Birth Control Pills Containing Drospirenone Drospirenone with Ethinyl Estradiol FDA
2011-10-28 Teva Pharmaceuticals Stops Making Mebendazole Mebendazole FDA
2011-11-02 FDA Issues Safety Review Update of Medications Used to Treat Attention-Deficit/Hyperactivity Disorder (ADHD) Lisdexamfetamine FDA
2011-11-04 FDA Requires Closer Review of Adverse Event Reports for Tumor Necrosis Factor (TNF) Blockers Etanercept FDA
2011-11-04 FDA Reminds Healthcare Providers and Patients to Enroll in the Avandia-Rosiglitazone Medicines Access Program Glimepiride and Rosiglitazone FDA
2011-11-09 FDA Issues Safety Review Update of Medications Used to Treat Attention-Deficit/Hyperactivity Disorder (ADHD) Atomoxetine FDA
2011-11-09 Manufacturing Delays May Affect Availability of Antibiotic Tetracycline Tetracycline FDA
2011-11-09 FDA: Trilipix (fenofibric acid) May Not Lower a Patient's Risk of Having a Heart Attack or Stroke Fenofibric Acid FDA
2011-11-17 FDA Requests a Stop to the Distribution of Pennsaid Samples Diclofenac FDA
2011-11-21 FDA Announces Avastin Not Shown to Be Safe and Effective in Breast Cancer Patients Bevacizumab FDA
2011-12-06 G & W Laboratories Inc. Recalls Single Lot of Migergot (Ergotamine Tartrate and Caffeine Suppositories) Caffeine with Ergotamine Tartrate FDA