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FDA Weighs Whether Testosterone Replacement is Safe

Sarah N. Emery
Associate Attorney at Schachter Hendy & Johnson PSC
Posted on Oct 28, 2014

According to the Wallstreet Journal, the Food and Drug Administration is trying to decide whether taking hormone supplements, which promise to battle that natural decline, is safe.

More than 2.3 million American men used testosterone gels, patches, pellets and injections last year—twice the number as in 2008. Some experts say these men may be increasing their chances of having a heart attack.

An FDA advisory panel in September urged the agency to require testosterone-product manufacturers to study if there are cardiovascular risks. The panel also recommended new labeling to say testosterone drugs, which were first approved in the 1950s to treat severe hormonal deficiencies, haven’t been shown to be safe and effective for boosting age-related drops in testosterone. Only about half of men filling testosterone prescriptions have been formally diagnosed as deficient in the hormone, according to an FDA review.

“Men all want to feel younger and more virile, and they somehow have come to believe that low-T medication is the fountain of youth. But we don’t know whether it’s safe,” says Steven Nissen, chairman of cardiovascular medicine at the Cleveland Clinic.

Testosterone is a male steroid hormone that rises sharply when boys hit puberty. It affects the entire body—voices deepen, shoulders broaden, sperm production begins, and height, strength and sex drive all increase. Levels peak in the early 30s and decline gradually, about 1% a year, as men age.

There is little agreement on what level of testosterone constitutes “low” in older men. Some doctors say a total testosterone level of below 325 nanograms per deciliter, at any age, indicates hypogonadism, the official term for low-T.

Some doctors apparently aren’t checking patients’ testosterone levels. An FDA analysis of insurance claims found that for 21% of men who filled testosterone prescriptions, there was no record of a lab test, either before or afterward.

Safety concerns have dogged testosterone products for decades. Large doses, which some bodybuilders take to bulk up, have been linked to aggression. Testosterone isn’t recommended for men with a history of prostate cancer, although studies show it doesn’t raise the risk for developing prostate cancer, as was once thought.

The cardiovascular concerns flared this past November when a widely publicized study in the Journal of the American Medical Association of nearly 9,000 veterans being evaluated for coronary artery disease found that those who used testosterone had a 29% higher risk of heart attack and stroke than those who didn’t.

Testosterone prescriptions dropped from about 600,000 a month before the JAMA study was published to about 500,000 a month currently.

In July, Canada’s drug regulatory agency said its review had found “a growing body of evidence” associated with testosterone use of “heart attack, stroke, blood clots and increased or irregular heart beat.” The agency ordered makers of the products to add a warning to their labels.

Some testosterone-treatment proponents acknowledge the drugs could increase cardiovascular risks because they boost levels of red blood cells, which make blood thicker. But they say donating a pint of blood every few months can keep these levels within normal ranges. “If a patient is carefully monitored, it’s not a concern,” says Mark Rosenbloom, who runs a clinic in Northbrook, Ill., specializing in testosterone- and other hormone-replacement therapy.

The FDA advisory panel, after two days of hearing expert testimony, voted overwhelmingly that more data was needed to assess the heart risks of testosterone products. The panel also recommended that labels should be changed to discourage the drugs’ use for “age-related” declines of the hormone.

If you or a loved one had a heart attack, stroke, pulmonary embolism, congestive heart failure or blood clot while taking testosterone, please call our experienced AndroGel attorneys at (888) 606-5297 for a free consultation about your potential AndroGel lawsuit.

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