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After a recent study raised concerns about testosterone replacement therapy and the risk of heart attacks, health experts are weighing in on the potential misuse of the therapy. AndroGel, for example, was initially approved in 2000 for the treatment of primary hypogonadism (a condition in which the body doesn’t produce enough testosterone), and hypogonadotropic hypogonadism (a lack of testosterone caused by a problem with the pituitary gland or hypothalamus).

Recent research, however, has indicated that the drug has been much more widely prescribed and advertised, potentially raising health risks for many men.

Men with Normal Testosterone Levels Taking TT

On January 29, 2014, PLOS One published a study on over 55,000 men who had all received a prescription for testosterone therapy (TT). They found that those 65 years and older had double the risk of a heart attack in the months after beginning the treatment. Men younger than 65 years who had a history of heart disease had almost triple the risk of heart attacks.

According to another recent study, many of these men should not even be taking TT. Researchers looked at data for over 400,000 men in the U.S., and nearly 7,000 in the U.K. who had started taking testosterone. They also looked at over a million U.S. men and over 66,000 U.K. men who had gone through laboratory testing to determine their testosterone levels.

Results showed that overall, testosterone testing and supplementation have increased. CBS News reported the same findings, noting that annual prescriptions for testosterone more than doubled in just four years to 430 million—surpassing sales for Viagra.

In addition, results showed that though increased testing in the U.K. has identified more men with low testosterone levels, U.S. testing has increased among those with normal levels. “Men in the U.S. tend to initiate at normal levels more often than in the U.K.,” the researchers wrote, “and many men initiate testosterone without recent testing.”

They concluded that given the increased use of these drugs and because of the new safety questions, doctors must be more careful to consider the medical necessity of the prescription before giving it to patients.

Lack of Adequate Labeling

In response to the January PLOS One study, the FDA has begun a new investigation into the safety of TT. So far, the risk of heart attacks is not listed on the label. Men who have allegedly suffered such injuries as a result of taking the therapy may be eligible for a lawsuit. Already, five men have filed cases in the Northern District of Illinois, Chicago, where the manufacturer of AndroGel—AbbVie—is headquartered.

The plaintiffs claim the company didn’t provide adequate warnings as to the risks of the therapy before making it available to the public. They also claim the company should have done additional studies to uncover all the risks before launching the product on such a broad basis.

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