FDA News & Alerts
FDA Calls for Warning on Cipro, Levaquin and Other Antibiotics
The U.S. Food and Drug Administration (FDA) has notified manufacturers of fluoroquinolone antimicrobial drugs that a Boxed Warning in the product labeling concerning the increased risk of tendinitis and tendon rupture is necessary. The medications involved in this action are: Cipro and generic ciprofloxacin, Cipro XR and Proquin XR (ciprofloxacin extended release), Factive (gemifloxacin),... »
FDA Warns of Cancer Risk for Regranex in Treatment of Diabetics’ Foot and Leg Ulcers
The U.S. Food and Drug Administration (FDA) has announced the addition of a boxed warning to the label of Regranex Gel 0.01% (becaplermin) to address the increased risk of cancer mortality in patients who use 3 or more tubes of the product. Regranex is a topical cream indicated for the treatment of leg and... »
FDA Approves NovoSeven RT Coagulation Therapy
A new formulation of a genetically engineered version of Factor VIIa, a plasma protein essential for the clotting of blood—has been approved by the FDA. The new formulation allows the product to be stored at room temperature (up to 77 degrees Fahrenheit) for up to two years. »
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... »
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... »
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. »
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... »
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. »