WASHINGTON, Nov. 2 The U.S. Food and Drug Administration says consumers should stop using two unapproved drug products advertised as treatments for erectile disfunction.
The FDA said True Man Sexual Energy Nutrient Capsules and Energy Max Energy Supplement Men's Formula Capsules contain potentially harmful, undeclared ingredients. The products, often advertised as natural alternatives to approved erectile dysfunction drugs, could interact with medications and cause dangerously low blood pressure, the agency said in a news release Friday.
"The risk is even more serious because consumers may not know that these ingredients can interact with medications and dangerously lower their blood pressure," said Dr. Janet Woodcock, acting director of the FDA's Center for Drug Evaluation and Research.
The agency has requested that the products, distributed by America True Man Health Inc. of West Covina, Calif., be recalled.
FDA chemical analysis has shown Energy Max contains thione, an analog of sildenafil, a substance similar to the active ingredient in the approved ED drug Viagra. True Man contains the same analog or an analog of vardenafil, the active ingredient Levitra.
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