FDA news and alerts: New formulation of ED drug approved; warning issued on certain ED supplements

Men who take drugs to help them achieve an erection often report that having sex feels like playing beat the clock. Although the “window of opportunity” has gotten longer, men still feel rushed to have sex before the drug is flushed out of their system.

Eager to allow users more spontaneity, the maker of Cialis (tadalafil) received FDA approval for a once-a-day formulation. With a slightly lower daily dose, men will not need to take the drug in anticipation of having sex because it will already be in their system. Two other erectile dysfunction (ED) drugs — Viagra (sildenafil) and Levitra (vardenafil) — can be taken daily, but lack FDA approval of a daily regimen.

Any one of the three prescription drugs, however, is a better bet than several supplements marketed for the treatment of ED and for “sexual enhancement.” The FDA recently announced that consumers should not buy or use supplements called Super Shangai, Strong Testis, Shangai Ultra, Shangai Ultra X, Lady Shangai, and Shangai Regular, a.k.a. Shangai Chaojimengnan. Although they are labeled as dietary supplements, chemical tests proved that they contain some of the active ingredients in approved ED drugs, making them illegal.

And because they have not been approved by the FDA, “the safety, efficacy, and purity of these ingredients cannot be validated,” according to a December 2007 press release. Furthermore, the substances could interact with other medications, causing serious side effects. Anyone who has used these products and experienced side effects should consult his doctor and report the incident to the FDA at 1-800-FDA-1088 or online at www.fda.gov/medwatch/report.htm.