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FDA Announces New Boxed Warning on Plavix

The U.S. Food and Drug Administration today added a boxed warning to the anti-blood clotting drug Plavix (clopidogrel), alerting patients and health care professionals that the drug can be less effective in people who cannot metabolize the drug to convert it to its active form.

FDA Issues Warning on Counterfeit Surgical Mesh

The U.S. Food and Drug Administration today warned health care providers and consumers about counterfeit surgical mesh being distributed in the United States under the C. R. Bard/Davol brand name. Surgical mesh products are used to reinforce soft tissue where weakness exists.

FDA Approves Botox to Treat Spasticity in Flexor Muscles of the Elbow, Wrist and Fingers

The U.S. Food and Drug Administration today approved Botox (onabotulinumtoxin A) to treat spasticity in the flexor muscles of the elbow, wrist, and fingers in adults. Spasticity is common after stroke, traumatic brain injury, or the progression of multiple sclerosis.

FDA Investigation Reveals Salmonella Tennessee at Plant that Makes Flavor Enhancers for Food Processors and Other Distributors

The U.S. Food and Drug Administration is actively investigating positive findings of Salmonella Tennessee in hydrolyzed vegetable protein (HVP) manufactured by Basic Food Flavors Inc. in Las Vegas, Nev. HVP is a flavor enhancer used in a wide variety of processed food products such as soups, sauces, chilis, stews, hot dogs, gravies, seasoned snack foods, dips and dressings. It is often blended with other spices to make seasonings that are used in or on foods. There are no reports of consumer illness associated with this recall. Only HVP manufactured by Basic Food Flavors is involved in this recall.

FDA Approves Name Change for Heartburn Drug Kapidex

The U.S. Food and Drug Administration has approved a name change for the heartburn drug Kapidex Change to Dexilant is part of FDA effort to prevent medication errors(dexlansoprazole) to avoid confusion with two other medications – Casodex and Kadian. Effective in late April 2010, Takeda Pharmaceuticals North America Inc. will market Kapidex under the new name Dexilant.

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