Safety Alerts & Recalls

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Warnings of Risk of Abnormal Heart Rhythm Added to Prescribing Information for Invirase
The U.S. Food and Drug Administration (FDA) has announced that new safety information has been added to the label for the HIV antiviral drug Invirase (saquinavir). The new warnings alert patients and their healthcare professionals to the potential risk of changes in the electrical activity of the heart when Invirase (saquinavir) is used with Norvir (ritonavir), another HIV antiviral medication. Changes in the electrical activity of the heart may lead to abnormal heart rhythms. Patients at particular risk of heart problems with Invirase and Norvir are those with underlying heart conditions or those who have existing heart rate or rhythm problems. The FDA will also require that a Medication Guide be given to patients when picking up a prescription for Invirase. The Medication Guide will include information on the risk of abnormal heart rhythms. This FDA action is in follow-up to the FDA's ongoing safety review of Invirase described in a February 2010 iGuard Safety Alert. For more information, please visit: http://www.fda.gov/Drugs/DrugSafety/ucm230096.htm To view the February 2010 iGuard Safety Alert, please visit: https://www.iguard.org/alerts/alert/822.html
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New Safety Warnings Added to Gonadotropin-Releasing Hormone (GnRH) Agonists
The U.S. Food and Drug Administration (FDA) has asked manufacturers to add new warnings to the labeling of gonadotropin-releasing hormone (GnRH) agonists, a class of drugs primarily used to treat men with prostate cancer. The warnings will alert patients and their health care professionals to the potential risk of heart disease and diabetes in men treated with these medications. This FDA action is in follow-up to a preliminary analysis that found that patients receiving GnRH agonists were at a small increased risk for diabetes, heart attack, stroke, and sudden death. These concerns were described in a May 2010 iGuard Safety Alert about the FDA's ongoing safety review of GnRH agonists. GnRH agonists are drugs that lower male hormones, which has the effect of shrinking prostate tumors or slowing the growth of prostate cancer. GnRH agonists are also used by women in the management of endometriosis. GnRH agonists include leuprolide (Eligard, Lupron, Viadur), goserelin (Zoladex), triptorelin (Trelstar), histrelin (Supprelin, Vantas), and nafarelin (Synarel). For more information, please visit: http://www.fda.gov/Drugs/DrugSafety/ucm229986.htm To view the May 2010 iGuard Safety Alert, please visit: https://www.iguard.org/alerts/alert/945.html
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Date Published Title Drug Source
2010-10-21 Warnings of Risk of Abnormal Heart Rhythm Added to Prescribing Information for Invirase Saquinavir FDA
2010-10-21 New Safety Warnings Added to Gonadotropin-Releasing Hormone (GnRH) Agonists Lupron FDA
2010-10-21 Hormone Replacement Therapy After Menopause Associated with Higher Risk of Aggressive Form of Breast Cancer Angeliq MediGuard CRT
2010-10-21 Hormone Replacement Therapy After Menopause Associated with Higher Risk of Aggressive Form of Breast Cancer Estrogens Conjugated with Medroxyprogesterone MediGuard CRT
2010-10-19 McNeil Consumer Healthcare Recalls Single Lot of Tylenol 8 Hour Caplets Acetaminophen Manufacturer
2010-10-15 FDA Provides Answers to Common Questions About Unapproved Chelation Products FDA
2010-10-13 FDA Updates Prescribing Information to Warn of Possible Fracture Risk With Osteoporosis Drugs Ibandronate Sodium FDA
2010-10-10 Pfizer Recalls Several Bottles of Lipitor Because of Strange Smell Atorvastatin Manufacturer
2010-10-08 Abbott Laboratories Agrees to Withdraw Its Obesity Drug Meridia Sibutramine FDA
2010-10-04 Bristol-Myers Squibb Co. is Recalling 60 Million Tablets of Avalide Hydrochlorothiazide with Irbesartan Manufacturer
2010-10-01 Withdrawal of Unapproved Oral Colchicine Products Colchicine FDA
2010-09-28 Manufacturer Withdraws All Lots of Octagam FDA
2010-09-27 Abbott Voluntarily Recalls Certain Similac Brand Powder Infant Formulas That Did Not Meet Quality Standards Manufacturer
2010-09-24 Amgen Issues Epogen/Procrit Voluntary Recall: Glass Flakes Found in VIals Epoetin Alfa Manufacturer
2010-09-23 Avandia: Restricted Access Program To Be Developed Glimepiride and Rosiglitazone FDA
2010-09-19 FDA Issues Statement on Possible Increased Risk of Rare Bone Fractures with Long-Term Bisphosphonate Use Ibandronate Sodium FDA
2010-09-17 FDA Announces Safety Review of Actos (Pioglitazone) for Cancer Risk Glimepiride and Pioglitazone FDA
2010-09-16 FDA Announces New Pediatric Dosing Guidelines for Valcyte Valganciclovir FDA
2010-09-11 FDA Sends Warning Letters to Makers of Electronic Cigarettes FDA
2010-08-20 FDA: Ongoing Safety Review of Stalevo and Possible Increased Risk of Heart Attack and Stroke Entacapone FDA
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