FDA recalls erectile dysfunction supplement - California product injury news

2009-05-01 04:43:10 (GMT) (JusticeNewsFlash.com - Justice News Flash, Product liability)

FDA recalls ED drug for high risk medication ingredient

California ED supplement maker recalls Libimax for serious injury hazard.

San Francisco, CA(JusticeNewsFlash.com)–The U.S. Food and Drug Administration (FDA) www.fda.gov federal regulators discovered Libimax, health supplement, contains an undeclared prescription drug ingredient, tadalafil and may cause injury to unknowing consumers. Nature & Health Company, located in Brea, California was informed of the positive lab analysis results by FDA officials and agreed to voluntarily recall the over the counter health supplement marketed as a male enhancement for men suffering from erectile dysfunction (ED).

The FDA approved tadalafil as an active ingredient in a drug for prescription use in the treatment of ED but has not approved the use of tadalafil by Nature & Health Co., in their Libimax ED supplement. Federal regulators say the drug is a threat to consumers because tadalafil can interact with nitrates found in most prescription drugs, like nitroglycerin, used to treat serious and critical heart conditions. Tadalafil can cause lethal interactions dropping blood pressures to dangerously low levels. The unapproved recalled drug was distributed to retail stores in California, Georgia, Illinois, Texas, and Ohio.

Consumers with diabetes, high blood pressure, high cholesterol, or heart disease typically take nitrates and should not be ingesting any supplement or medication with tadalafil as an ingredient without consulting their doctor. Erectile dysfunction is common in men with these medical conditions and these consumers seek alternative products to enhance their sexual performance. Consumers who have bought the defective product, Libimax, should stop taking the supplement immediately and contact their physician.
Consumers can go to www.fda.gov for detailed information about the recalled drug product and report any adverse symptoms, illness, or injury by accessing www.fda.gov/Med/Watch/report.htm or phone 1-800-FDA-1088.

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