Safety Alerts & Recalls

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FDA Warns of Abnormal Heart Rhythms with Azithromycin (Zithromax or Zmax)
The Food and Drug Administration (FDA) is warning the public that azithromycin (Zithromax or Zmax) can cause abnormal changes in the electrical activity of the heart (QT interval prolongation) that may lead to a rare type of irregular heart rhythm called torsades de pointes. These irregular heart rhythms potentially may lead to death. Patients at particular risk for developing this condition include those with known risk factors such as existing QT interval prolongation, low blood levels of potassium or magnesium, a slower than normal heart rate, or use of certain drugs used to treat abnormal heart rhythms, or arrhythmias. The prescribing information for azithromycin products has been updated to strengthen the Warnings and Precautions section with this information related to the risk of QT interval prolongation and torsades de pointes. Azithromycin is also known by the names Zithromax, ZMax, or Z-Pak. Azithromycin is used to treat infections, including infections of the lung or sinuses, community-acquired pneumonia, pharyngitis/tonsillitis, skin infections, as well as urinary tract, cervical, and genital infections. For more information, please visit:
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Affymax and Takeda Announce a Recall of All Lots of Omontys (Peginesatide) Injection
Affymax, Inc. and Takeda Pharmaceutical Company Limited (Takeda) have decided to voluntarily recall all lots of Omontys (peginesatide) Injection because of new postmarketing reports of serious hypersensitivity reactions (commonly called allergic reactions), including anaphylaxis which can be life-threatening or fatal. Typically administered in dialysis centers, Omontys is indicated for the treatment of anemia due to chronic kidney disease in adult patients on dialysis. The companies have been working actively with the U.S. Food and Drug Administration (FDA) and have also issued a letter to health care professionals indicating that no new or existing patients should receive Omontys. To date, fatal reactions have been reported in approximately 0.02% (about 1 in 2500) of patients following the first dose of intravenous administration. The reported serious hypersensitivity reactions have occurred within 30 minutes after such administration of Omontys. There have been no reports of such reactions following subsequent dosing, or in patients who have completed their dialysis session. For more information, please visit:
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Date Published Title Drug Source
2013-03-12 FDA Warns of Abnormal Heart Rhythms with Azithromycin (Zithromax or Zmax) Azithromycin FDA
2013-02-25 Affymax and Takeda Announce a Recall of All Lots of Omontys (Peginesatide) Injection Peginesatide Manufacturer
2013-02-03 Novartis Recalls Several Lots of Triaminic® and Theraflu Warming Relief® Syrups Manufacturer
2013-01-18 Rugby Natural Iron Supplement Recalled Because Bottle May Contain Nausea Medicine Meclizine Iron FDA
2013-01-14 Abbott Laboratories Recalls Single Lot of Synthroid tablets, 150 mcg Levothyroxine FDA
2013-01-14 Mylan Pharmaceuticals Inc. Recalls Several Lots of Tacrolimus Capsules 0.5 mg Tacrolimus FDA
2013-01-10 FDA Lowers Recommended Dose of Sedative Zolpidem (Ambien, Ambien CR, Edluar, and Zolpimist) Zolpidem FDA
2013-01-03 Physicians Total Care Recalls Several Lots of Enjuvia Tablets Estrogens Conjugated FDA
2013-01-02 Watson Pharma Recalls Select Lots of Caziant (Desogestrel and Ethinyl Estradiol) Tablets Desogestrel with Ethinylestradiol FDA
2013-01-02 Genentech USA, Inc. Recalls Several Lots of CellCept Capsules, 250 mg Mycophenolate FDA
2013-01-02 Johnson and Johnson Recalls Several Lots of Clean & Clear Advantage, 3-in-1 foaming Wash Salicylic Acid FDA
2012-12-20 Pradaxa Contraindicated in Patients With Mechanical Heart Valves Dabigatran FDA
2012-12-19 FDA Warns That Hepatitis C Drug Incivek Can Cause Potentially Fatal Skin Reactions Telaprevir FDA
2012-12-19 Zicam Extreme Congestion Relief Nasal Gel Recalled Because of Bacteria Contamination Manufacturer
2012-12-17 FDA Warns Against Use of Xyrem With Alcohol, Insomnia Medicines, and Others Sodium Oxybate FDA
2012-12-12 FDA Publishes Results of Safety Review Update of Chantix and Risk of Heart Attack and Stroke Varenicline FDA
2012-12-11 Proctor and Gamble Recalls Select Lots of Vicks NyQuil Cold & Flu, Nighttime Relief FDA
2012-12-11 GlaxoSmithKline Recalls Several Lots of Advair HFA 45/21 Inhalers Fluticasone Propionate with Salmeterol FDA
2012-12-07 Qualitest Recalls Over One Hundred Lots of Hydrocodone Bitartrate and Acetaminophen Tablets Hydrocodone with Acetaminophen FDA
2012-12-03 Raritan Pharmaceuticals Recalls Several Lots of Store Branded Fiber Supplements Psyllium Husk FDA
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