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Testosterone therapy popular, but is it safe?

By Wire services
Published November 13, 2003

WASHINGTON - With millions of middle-age and older men turning to testosterone therapy in a bid to beat aging, experts Wednesday urged caution until science has a chance to catch up with the trend.

"There is a concern that the popular drive to increase testosterone levels among many men may trump science in this instance. We don't have the data to demonstrate whether any benefits might outweigh potential risks," said Dr. William Hazard, a geriatric specialist at the University of Washington and a member of the Institute of Medicine's committee that considered research needs for testosterone therapy.

The Food and Drug Administration has approved testosterone therapy only to treat a few relatively rare medical conditions marked by inadequate production of the male sex hormone, mainly in young men, such as hypogonadism.

But "off-label" use of the hormone - delivered by injection, and more commonly by patch or gel - has soared in recent years as testosterone has come to be viewed as a sort of hormonal tonic against aging in men, backed by some small studies that suggest it might help complaints ranging from reduced bone and muscle mass to memory loss and reduced sex drive.

More than 1.75-million prescriptions for testosterone products were written in 2002 - a 170 percent increase from 1999 - for an estimated 800,000 patients. Because only about 5 percent of the 4-million to 5-million men with hypogonadism are thought to be getting treatment, that suggests a lot of testosterone users are in a gray zone.

Researchers know testosterone production peaks in the 20s for most men and then begins a steady decline into old age. But there is considerable disagreement over whether men reach a point where they virtually cease producing testosterone - andropause - in the same way menopausal women stop estrogen production. "There have been only 31 small placebo-controlled studies of testosterone therapy in men ages 65 and older, and just one lasted longer than a year," said Dr. Dan Blazer, a professor of psychiatry and behavioral sciences at Duke University Medical Center who served as chairman of the committee.

"There is still much we don't know about normal levels of testosterone at different ages, how decreased testosterone levels affect men's health and whether testosterone therapy might increase the risk of prostate cancer," Blazer said.

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