MedNews — FDA News & Alerts
New Crohn's Disease Treatment Approved by FDA
The U.S. Food and Drug Administration (FDA) has approved a new medicine called Cimzia for the treatment of Chron's disease. The drug is manufactured by UCB, Inc., and is known as a tumor necrosis factor (TNF) blocker. It is used to reduce the signs and symptoms of moderately to severely active Crohn's disease in adult patients who have not been helped enough by usual treatments. More »
FDA Approves Amitiza to Treat Irritable Bowel Syndrome (IBS-C)
The U.S. Food and Drug Administration has approved Amitiza (lubiprostone) for the treatment of Irritable Bowel Syndrome with Constipation (IBS-C) in adult women aged 18 and over. There is currently no prescription drug therapy for IBS-C. With this approval, Amitiza becomes the only FDA-approved medical treatment for IBS-C available in the United States. More »
Is the Information We Have About Pharmaceutical Drugs Really Reliable?
A report in the current issue of the British Medical Journal questions the reliability of what we know about the latest drugs, such as antidepressants or statins. More »
FDA Warns of Potential Dangers of Botox and Botox Cosmetic
The U.S. Food and Drug Administration today notified the public that Botox and Botox Cosmetic (Botulinum toxin Type A) and Myobloc (Botulinum toxin Type B) have been linked in some cases to adverse reactions, including respiratory failure and death, following treatment of a variety of conditions using a wide range of doses.
In an early communication based on the FDA's ongoing safety review, the agency said the reactions may be related to overdosing. There is no evidence that these reactions are related to any defect in the products. More »
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. More »
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, suicidal ideation, and actual suicidal behavior. More »
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. More »
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 cholesterol lowering drug. Vytorin contains both Zetia (ezetimibe) and Zocor (simvastatin) in one tablet. More »
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 form of influenza for humans, and has been the cause of major epidemics. The new panel is also the first test for human metapneumovirus (hMPV), newly identified in 2001. More »
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. More »
