Safety Alerts & Recalls

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FDA Reminds Healthcare Providers and Patients to Enroll in the Avandia-Rosiglitazone Medicines Access Program
The U.S. Food and Drug Administration (FDA) is reminding healthcare providers and patients about the need to enroll in the Avandia-Rosiglitazone Medicines Access Program by November 17, 2011 in order to continue prescribing and receiving rosiglitazone-containing medicines (Avandia, Avandamet, and Avandaryl) without interruption. After November 18, 2011, rosiglitazone medicines will no longer be available through retail pharmacies and will only be available by mail order through specially certified pharmacies participating in the program. Program enrollment information is available on the Avandia website (www.avandia.com). The FDA previously communicated about the restrictions to the prescribing and use of rosiglitazone medicines in the May 18, 2011 Drug Safety Communication. For more information, please visit: http://www.fda.gov/Drugs/DrugSafety/ucm277629.htm To view the MediGuard alert about the FDA's May 18, 2011 Drug Safety Communication, please visit: https://www.mediguard.org/alerts/alert/1408.html
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FDA Requires Closer Review of Adverse Event Reports for Tumor Necrosis Factor (TNF) Blockers
The U.S. Food and Drug Administration (FDA) is updating the public about its ongoing safety review of Tumor Necrosis Factor (TNF) blockers and malignancy (cancer) in children, adolescents, and young adults (30 years of age or younger). The FDA is requiring the manufacturers of TNF blockers to perform enhanced safety monitoring for these products. This more complete safety monitoring will help improve the understanding of the safety of TNF blockers. The FDA will update the public if new information becomes available. TNF blockers are a class of biologic products that are used to treat Crohn's disease, ulcerative colitis, rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, plaque psoriasis, and/or juvenile idiopathic arthritis. TNF blockers include Remicade (infliximab), Enbrel (etanercept), Humira (adalimumab), Cimzia (certolizumab pegol), and Simponi (golimumab). For more information, please visit: http://www.fda.gov/Drugs/DrugSafety/ucm278267.htm
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Date Published Title Drug Source
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
2011-09-16 FDA Warns: Abnormal Heart Rhythms May Be Associated with Use of Zofran (Ondansetron) Ondansetron FDA
2011-09-08 Pure Encapsulations, Incorporated Recalls Prenatal Nutrients Products Prenatal Vitamins FDA
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