FDA News & Alerts
Generic Fosamax Approved for Osteoporosis Treatment
The U.S. Food and Drug Administration today approved the first generic versions of Fosamax (alendronate sodium tablets), used to treat osteoporosis, a condition that causes thinning and weakening of a person's bones. »
FDA Warns of Possible Neuropsychiatric Side Effects to Pfizer’s Anti-Smoking Drug, Chantix (varenicline)
The U.S. Food and Drug Administration (FDA) has issued a Public Health Advisory to alert health care providers, patients, and caregivers to new safety warnings concerning Prfizer's anti-smoking drug, Chantix (varenicline). The FDA's "Early Communication" advises that the agency is evaluating adverse event reports on Chantix related to changes in behavior, agitation, depressed mood,... »
Antiepileptic Drugs May Increase Suicidal Thoughts, Says FDA
The U.S. Food and Drug Administration (FDA) today issued new information to health care professionals to alert them about an increased risk of suicidal thoughts and behaviors (suicidality) in patients who take drugs called antiepileptics to treat epilepsy, bipolar disorder, migraine headaches, and other conditions. »
FDA Issues Early Communication about an Ongoing Review of Merck/Schering Plough’s Vytorin
The U.S. Food and Drug Administration today issued an Early Communication regarding the agency’s ongoing review of Vytorin based on preliminary results from a recently completed study—the Effect of Combination Ezetimibe and High-Dose Simvastatin vs. Simvastatin Alone on the Atherosclerotic Process in Patients with Heterozygous Familial Hypercholesterolemia (ENHANCE)—on this... »
Test for Respiratory Viruses Cleared by FDA
The U.S. Food and Drug Administration today cleared for marketing a test that simultaneously detects and identifies 12 specific respiratory viruses. The test, called the xTAG Respiratory Viral Panel, is the first test for the detection and differentiation of influenza A subtypes H1 and H3. Influenza A is the most severe... »
Boxed Warning Additions to GlaxoSmithKline’s Anti-Diabetes Drug Avandia
The U.S. Food and Drug Administration has announced that GalaxoSmithKline, the manufacturer of Avandia (rosiglitazone), has agreed to add new information to the existing boxed warning in the drug's labeling about potential increased risk for heart attacks. Avandia is used to treat type 2 diabetes. »
FDA Investigating Safety of Antifibrinolytic Drug, Trasylol
The U.S. Food and Drug Administration (FDA) is conducting a safety review of Bayer Pharmaceuticals' Aprotinin Injection (Trasylol), a drug used to control bleeding during heart surgery, after being notified that a Canadian research group halted a study on Trasylol because the drug appeared to increase the risk for death compared to the other... »
FDA Approves Bristol-Meyers Squibb’s Drug Ixempra for Breast Cancer Treatment
The U.S. Food and Drug Administration has approved Ixempra (ixabepilone), a new anti-cancer treatment, for use in patients with metastatic or locally advanced breast cancer who have not responded to certain other cancer drugs. Ixempra is indicated as monotherapy for the treatment of metastatic or locally advanced breast cancer in patients whose tumors are... »
FDA: Spontaneous Hearing Loss due to Viagra, Levitra and Cialis
The United States Food and Drug Administration (FDA) approved labeling changes for Viagra, Cialis and Levitra that "more prominently display the potential risk of sudden hearing loss." While rare, there have been reported incidents of single-sided hearing loss in patients taking the above erectile dysfunction drugs (Type 5 PDE5 inhibitors). The labeling change was prompted... »
It’s Official! Feds Nix Cold and Cough Meds for Kids Under Six
After weeks of speculation, the Food and Drug Administration (FDA) took the additional step of recommending that cold and cough medicines used by parents for generations no longer be administered to children under six. While the resolution of the FDA is "not binding," it will surely impact how such medications are marketed, displayed and... »