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FDA Has Double Standard On Testosterone

SEX! From the beginning of human history sex has been a topic of compelling interest. And people can’t seem to get enough. They have been trying to concoct aphrodisiacs for thousands of years.

Truffles, oysters, artichokes and crocodile kidneys all seemed exotic enough to stimulate sexual desire. Rhinoceros horn and ginseng have been popular in east Asia for centuries. But despite a lot of wishful thinking, there is no evidence that such products actually work as love potions.

Although Viagra, Levitra and Cialis allow many men to achieve a satisfactory erection, they are not aphrodisiacs. But the idea of better performance is enough to increase some men’s interest in sexual activity.

What about their partners, though? The popularity of drugs for ED has revealed a surprising number of women who just aren’t very interested in sex. Many of them have lost their libido, in part because of postmenopausal hormonal changes.

An FDA panel just recommended against approving the only medication that has been shown to increase women’s sex drive. The medicine is testosterone.

Testosterone is normally thought of as a male sex hormone, but women make it too. With age, levels can drop in both men and women.

Research dating to 2000 showed that a testosterone patch or sublingual (under the tongue) tablet could increase sexual fantasies and arousal in women significantly more than placebo.

Why did the expert committee balk at a testosterone patch (Intrinsa) for women? For one thing, increased desire is harder to measure than improved erections. The panel was not convinced that the patch was so much better than placebo that it deserved approval.

The experts also suggested that there are concerns about long term safety. Fears were expressed that testosterone might carry cardiovascular risks or even increase the danger of breast cancer. Memories of the HRT scandal may have influenced the panel.

Some women who testified that testosterone gave them back their sexuality might have wondered whether the FDA experts were applying a double standard. Testosterone has been available for prescription use in men for years. There are no long-term studies of its risks, but that does not seem to have bothered the FDA.

The drug Estratest, which combines estrogen and methyltestosterone, has been available for years for postmenopausal women. The FDA has looked the other way on off-label use of testosterone by women wishing to improve libido and sexual enjoyment. It is estimated that 20 percent of the prescriptions written for testosterone are for women. Compounding pharmacists have also been creating a variety of testosterone products for women.

Even if the FDA doesn’t approve the Intrinsa testosterone patch, women may continue to take testosterone without much oversight. This might pose unexpected problems.

For more information on the benefits and risks of testosterone and other sexual issues, we offer readers of this column our Guides to Female Sexuality and Sexual Dysfunction. Anyone who would like copies, please send $3 in check or money order with a long (no. 10) stamped (60 cents), self-addressed envelope: Graedons’ People’s Pharmacy, No. PZ-9, P. O. Box 52027, Durham, NC 27717-2027.

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About the Author
Joe Graedon is a pharmacologist who has dedicated his career to making drug information understandable to consumers. His best-selling book, The People’s Pharmacy, was published in 1976 and led to a syndicated newspaper column, syndicated public radio show and web site. In 2006, Long Island University awarded him an honorary doctorate as “one of the country's leading drug experts for the consumer.”.
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