Safety Alerts & Recalls

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Latest Alerts

Manufacturing Delays May Affect Availability of Antibiotic Tetracycline
Watson and Teva Pharmaceuticals, two companies who make Tetracycline capsules, have announced they are experiencing manufacturing delays and all strengths of Tetracycline capsules will temporarily be unavailable. The companies cannot estimate a date for when the capsules will become available. Tetracycline is an antibiotic used to treat certain types of bacterial infections including pneumonia and other respiratory tract infections; acne; infections of skin, genital and urinary systems; and the infection that causes stomach ulcers (Helicobacter pylori). For more information, please visit: http://www.fda.gov/Drugs/DrugSafety/DrugShortages/ucm050792.htm#tetracycline
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FDA Issues Safety Review Update of Medications Used to Treat Attention-Deficit/Hyperactivity Disorder (ADHD)
In a follow up to a previous safety alert, the U.S. Food and Drug Administration (FDA) is updating the public that a large, recently-completed study in children and young adults treated with medication for Attention-Deficit/Hyperactivity Disorder (ADHD) has not shown an association between use of certain ADHD medications and heart-related adverse events, including stroke, heart attack (myocardial infarction or MI), and sudden cardiac death. The medications studied included stimulants: Methylphenidate (Concerta, Daytrana, Metadate CD, Metadate ER, Methylin, Methylin ER, Ritalin, Ritalin-LA, Ritalin-SR) Dexmethylphenidate HCl (Focalin, Focalin XR) dextroamphetamine sulfate (Dexedrine, Dexedrine Spansules, Dextroamphetamine ER, Dextrostat) Lisdexamfetamine dimesylate (Vyvanse) Amphetamine, mixed salts (Adderall, Adderall XR) Methamphetamine (Desoxyn) The study also included non-stimulants: Pemoline (Cylert-no longer marketed) Atomoxetine (Strattera) For more information, please visit: http://www.fda.gov/Drugs/DrugSafety/ucm277770.htm
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Date Published Title Drug Source
2011-11-09 Manufacturing Delays May Affect Availability of Antibiotic Tetracycline Tetracycline FDA
2011-11-09 FDA Issues Safety Review Update of Medications Used to Treat Attention-Deficit/Hyperactivity Disorder (ADHD) Atomoxetine FDA
2011-11-04 FDA Reminds Healthcare Providers and Patients to Enroll in the Avandia-Rosiglitazone Medicines Access Program Glimepiride and Rosiglitazone FDA
2011-11-04 FDA Requires Closer Review of Adverse Event Reports for Tumor Necrosis Factor (TNF) Blockers Etanercept FDA
2011-11-02 FDA Issues Safety Review Update of Medications Used to Treat Attention-Deficit/Hyperactivity Disorder (ADHD) Lisdexamfetamine FDA
2011-10-28 Teva Pharmaceuticals Stops Making Mebendazole Mebendazole 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
2011-10-25 FDA: Xigris [drotrecogin alfa (activated)] Withdrawn From Market Due to Failure to Show Benefit FDA
2011-10-24 FDA Issues Safety Review Update on Chantix and Mental Health Adverse Effects Varenicline FDA
2011-10-22 Nostrilla Nasal Decongestant: Recall due to Bacterial Contamination Oxymetazoline Manufacturer
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
2011-10-21 FDA Updates Information about the Drug Interaction Between Linezolid (Zyvox) and Certain Certain Medicines for Depression, Anxiety, Bipolar Disorder, Insomnia Linezolid FDA
2011-10-20 Sanofi-Aventis Announces Shortage of Apidra SoloSTAR Pens Insulin Glulisine Manufacturer
2011-10-18 Study Links Vitamins to Increased Risk Of Death In Older Women Zinc MediGuard CRT
2011-10-17 Study Links High Doses of Vitamin E to Possible Increase in Prostate Cancer Risk Vitamin E MediGuard CRT
2011-10-11 Sprycel Linked To Raised Blood Pressure In The Lungs Dasatinib FDA
2011-10-03 Online Guide For Using Pain Relievers Safely Acetaminophen FDA
2011-09-26 The FDA Continues to Be Concerned about the Increase Risk of Blood Clots with YAZ (generics – Gianvi and Loryna), Yasmin (generics – Ocella, Syeda, and Zarah), Beyaz, and Safyral Drospirenone with Ethinyl Estradiol FDA
2011-09-22 Users of Primatene Mist Will Need a Prescription Product to Treat Their Asthma Epinephrine FDA
2011-09-16 Qualitest Pharmaceuticals Recalls Birth Control Pills Due To Packaging Error that May Increase Risk of Unintended Pregnancies Desogestrel with Ethinylestradiol Manufacturer