FDA News & Alerts
Samsca Approved by FDA to Treat Hyponatremia
The U.S. Food and Drug Administration has approved Samsca tablets (tolvaptan) to treat hyponatremia, an abnormally low concentration of sodium in the blood. “With the approval of Samsca, physicians will have an additional tool to treat hyponatremia,” said Norman Stockbridge, M.D., director of the Division of Cardiovascular and Renal Products in the FDA’s Center for... »
FDA Approves Use of Temporary Pump to Assist Heart’s Right Side
The U.S. Food and Drug Administration(FDA) today approved a Humanitarian Device Exemption (HDE) for the first heart pump that provides certain critically ill patients with temporary support for the right side of the heart. The approval is a first for certain critically ill patients. »
Experimental Malaria Vaccines to be Tested in FDA and PATH-MVI Collaboration
The U.S. Food and Drug Administration has announced a collaboration with the PATH Malaria Vaccine Initiative (PATH-MVI) to develop laboratory tests to better predict the level of safety and effectiveness of experimental malaria vaccines before they are used in human clinical trials. »
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... »