FDA NEWS RELEASE (451 hits)

For Immediate Release: June 19, 2010
Media Inquiries: Elaine Gansz Bobo, 301-796-7567, elaine.bobo@fda.hhs.gov; Ira Allen, 301-796-5349; ira.allen@fda.hhs.gov
Consumer Inquiries: 888-INFO-FDA

FDA Warns Consumers to Avoid Magic Power Coffee
Product marketed as s*xual enhancement is contaminated with potentially dangerous ingredient

The U.S. Food and Drug Administration is warning consumers that Magic Power Coffee, an instant coffee product marketed as a dietary supplement for s*xual enhancement, contains an active drug ingredient that can dangerously lower blood pressure.

Consumers who have Magic Power Coffee should stop using it immediately. s*xual enhancement products that claim to work as well as prescription products are likely to expose consumers to unpredictable risks and the potential for injury or even death.

In the case of Magic Power Coffee, the FDA collected and analyzed the product and determined that the product contains hydroxythiohomosildenafil. This is a chemical similar to sildenafil, the active ingredient in Viagra. Hydroxythiohomosildenafil, like sildenafil, may interact with prescription drugs known as nitrates, including nitroglycerin, and cause dangerously low blood pressure. Consumers and health care professionals should be aware of this problem and the health hazard it presents.

When blood pressure drops suddenly, the brain is deprived of an adequate blood supply, which can lead to dizziness or lightheadedness.

"Because this product is an instant coffee labeled as an ‘all natural dietary supplement,’ consumers may assume it is harmless and poses no health risk," said Deborah M. Autor, director of FDA’s Center for Drug Evaluation and Research, Office of Compliance. "In fact, Magic Power Coffee can cause serious harm.”

To date, the FDA is not aware of any adverse events associated with the use of this product.

The product is distributed on Internet sites and online auctions by multiple independent distributors participating in an online multi-level marketing scheme. It is sold in a 2-serving box and a 12-serving carton containing six 2-serving boxes.

The FDA advises consumers who have experienced any negative side effects from s*xual enhancement products to consult a health care professional and to safely discard the product. Consumers and health care professionals should report adverse events to the FDA's MedWatch program at 800-FDA-1088 or online at www.fda.gov/medwatch/report.htm

During the past several years, the FDA has found many products marketed as dietary supplements for s*xual enhancement that contain undeclared active ingredients of FDA-approved drugs, analogs of approved drugs or other compounds that do not qualify as “dietary ingredients.” Multiple alerts issued by the FDA about these contaminated dietary supplements can be found here.

“The FDA is committed to protecting public health and stopping the illegal marketing of unapproved drugs,” said Autor. “We support vigorous law enforcement and criminal prosecution of violators of safe drug laws.

Posted By: Joan Gilchrist
Saturday, June 19th 2010 at 8:16PM
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