Marketed as a ’male sexual stimulant,’ product contains hidden drug ingredient The U.S. Food and Drug Administration says Vigor-25, a product marketed as a natural dietary supplement to enhance male sexual performance, should not be purchased or used because it contains sildenafil, the active ingredient in the prescription drug Viagra.

Xanodyne Pharmaceuticals Inc. which makes Darvon and Darvocet, the brand version of the painkiller propoxyphene, has agreed to withdraw the medication from the U.S. market at the request of the U.S. Food Administration. The FDA has also informed generic manufacturers of Xanodyne’s decision and they will be removing their propoxyphene-containing products from the market as well.

Xgeva, cancer

The U.S. Food and Drug Administration today warned four companies that the caffeine added to their malt alcoholic beverages is an “unsafe food additive” and said that further action, including seizure of their products, is possible under federal law. (DSK)

Halaven, metastatic breast cancer

Safety concerns on the devices that treat abnormal heart rhythms also to be addressed. The U.S. Food and Drug Administration today announced a program aimed at facilitating the development of safer, more effective external defibrillators used to treat abnormal heart rhythms through improved design and manufacturing practices.

This year, millions of antibiotics will be prescribed. Antibiotics can be used to treat bacterial infections; however, they are commonly over-prescribed. Patients sometimes ask their health care professional to prescribe antibiotic drugs for viral infections, like the common cold, despite the fact that they will not work and may lead to potentially harmful side effects. The misuse of antibiotics has contributed to one of the world’s most pressing public health problems today, antibiotic resistance.

Mauri Gorgonzola cheese with sell-by dates of 01/31/11 and 01/14/11 is being recalled because of a positive test for E. coli 0157:H7. DPI Specialty Foods of Tualatin, Ore., cut, packaged and distributed the cheese to Costco Wholesale Corporation (Costco) stores in Colorado.

lipodystrophy

Pharmaceutical Company Lawyer Charged with Obstruction and Making False Statements

Most makers of approved drug and biological products are meeting their regulatory obligations and meeting targets for postmarketing studies/clinical trials in a timely manner, according to a study released today by the U.S. Food and Drug Administration (FDA).

The U.S. Food and Drug Administration has been investigating reports that patients undergoing computed tomography (CT) brain perfusion scans were accidently exposed to excess radiation. The FDA found that when properly used, the CT scanners did not malfunction. Instead, it is likely that the improper use of the scanners resulted in these overdoses. However, the FDA has identified a series or promising steps to enhance the safety of these procedures. These steps could reduce the likelihood of radiation overexposure in the event of improper use of the CT scanners.

The U.S. Food and Drug Administration and the Maryland Department of Health and Mental Hygiene (DHMH) join Baugher Enterprise in warning consumers to not consume Baugher’s Apple Cider, as this cider may be associated with an outbreak of E. coli O157:H7 infections. The cider was available for sale in Maryland and Pennsylvania. (DSK)

• Bravo Farms Dutch Style Gouda cheese, (Costco item 40654) offered for sale and in cheese sampling events at Costco Wholesale Corporation (Costco) locations is preliminarily linked with an outbreak of E.coli O157:H7 infections.

The U.S. Food and Drug Administration today approved Cymbalta (duloxetine hydrochloride) to treat chronic musculoskeletal pain, including discomfort from osteoarthritis and chronic lower back pain. Cymbalta was first used to treat major depressive disorder in 2004.

Devices capturing digital image of breasts to be Class II. The U.S. Food and Drug Administration today announced that it is easing the pathway to market for mammography systems that produce computerized X-ray images of the entire breast.

A public-private organization will provide produce growers and packagers with fundamental, on-farm food safety knowledge, in advance of a proposed produce safety regulation, the U.S. Food and Drug Administration, the U.S. Department of Agriculture’s Agricultural Marketing Service (USDA/AMS), and Cornell University announced today. (DSK)

The U.S. Food and Drug Administration today announced a partnership agreement with the University of Rochester to form the Analgesic Clinical Trial Innovations, Opportunities, and Networks (ACTION) Initiative.

SEGA, Afinitor, tumors

Building upon the extensive testing and protocols already in use by federal, state and local officials for the fishing waters of the Gulf, NOAA and FDA have developed and are using a chemical test to detect dispersants used in the Deepwater Horizon-BP oil spill in fish, oysters, crab and shrimp. Trace amounts of the chemicals used in dispersants are common, and levels for safety have been previously set.