First Impotence Pill Approved by FDA

| May 1, 1998

Viagra, the first oral medication for impotence, was approved by the U.S. Food and Drug Administration (FDA) in March. In clinical studies, 64 to 72 percent of the patients successfully completed intercourse after taking Viagra.

As an oral medication, Viagra has been heralded by some health care professionals as easier to use and less embarrassing than the traditional treatments. It can be taken once a day, an hour before intercourse, and works by blocking an enzyme that is responsible for the breakdown of cyclic GMP, a chemical produced during sexual stimulation. Cyclic GMP is responsible for maintaining blood flow into the penis.

Until now the estimated 10 to 20 million American men suffering from recital dysfunction, the proper name for impotence, relied on treatments that had to be injected, inserted or implanted.

Many specialists hope that the approval of Viagra will encourage more people to seek medical help for impotence. Experts estimate that only one in six men with impotence seek treatment. Impotence is often caused by another medical condition and is a major complication of diabetes for men. It can also be a side effect of some drugs or have a psychological basis.

Dr. James Barada, an Albany, N.Y., physician representing the American Urological Association, urges patients to get treatment for the underlying condition. "This is a great advance in the sense that it will increase awareness of impotence treatments, but the pill is not going to be for everybody," he says.

Originally intended as a heart-drug and known chemically as sildenafil, Viagra's studies were continued by Pfizer after some heart patients reported unexpected erections.

Other oral impotence drugs being tested include apomorphine by Tap Pharmaceuticals. The tablet is designed to work in the central nervous system by stimulating the brain to send a message down the spinal cord to produce an erection. Vasomax, manufactured by Zonagen as a blood pressure drug, is also in the late stages of evaluation.

Experts warn that Viagra is not an aphrodisiac and is effective only in patients with a medical problem.

"Yes, it's an erection improver, but only in men with erectile dysfunction," said Dr. Harin Padma-Nathan, director of The Male Clinic in Santa Monica, Calif. "This drug does not change libido or desire ... and it's not going to have any impact on normal men."

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Categories: Diabetes, Food, Government & Policy, Men's Issues, Sexual Issues

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