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FDA Issues Warning on "Natural" Remedies for Erectile Dysfunction
The FDA has issued a warning about seven "natural" remedies for erectile dysfunction sold as dietary supplements because they contain illegal versions of prescription drugs.
The supplements involved are 4EVERON, Actra-Rx, Libidus, Nasutra, Neophase, Vigor-25, and Zimaxx. Today's actions follow a first-of-its-kind chemical analysis by the FDA that found Zimaxx actually contained sildenafil (Viagra) while the other products contained analogues of either sildenafil or vardenafil (Levitra). The analysis was performed on 17 products sold over the Internet for the treatment of erectile dysfunction or for sexual enhancement.
The products are often marketed as "all natural" alternatives to prescription drugs for the treatment of erectile dysfunction. But the FDA is warning consumers not to take these products because of the risk that they may interact with other prescription drugs containing nitrates and lower blood pressure to dangerous levels.
The FDA issued warning letters to the makers of these products and said there may be additional enforcement action.
Link: FDA statement (Free)
Published in Physician's First Watch July 13, 2006