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FDA Will Review Safety of Testosterone Therapy

Agency pointed to recent studies citing possible heightened heart risk tied to the treatments

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"We identified the [timing of the] first prescription and followed them for 90 days," Finkle said. The risk for heart attack doubled in that 90-day period for men over 65 and those under 65 with a history of heart disease, the researchers found.

When they continued to follow the men for another 90 days, the researchers said, the risk declined to the level it was at the study's start for men who did not refill their initial prescription.

Even though the two-fold increase in risk in younger men was seen only in those with a history of heart disease, Finkle said he's uncertain of the therapy's safety in younger, healthy men.

"We don't have enough evidence to say testosterone supplements in men under age 65 without heart disease are safe," he said.

Although the researchers found an association between testosterone therapy and increased risk of heart attack, the study did not prove a cause-and-effect relationship.

The study authors also did not examine the explanation for the link, but Finkle said it could be tied to the effect of testosterone in blood.

"The theory is that testosterone most likely promotes clotting," he said. In older men who tend to have thinner vessels, that clotting could cause problems, he said.

The supplements might also increase men's circulating estrogen, the researchers said. Estrogen therapy has been linked to an increase in heart troubles in both men and women.

AbbVie and Actavis, the makers of testosterone therapies, did not respond to requests for comment on the Plos One study.

However, one expert not involved in the research expressed skepticism, citing flaws in the study design.

"Based on the best available data, testosterone replacement still appears to be safe ... for properly selected patients," said Dr. Ryan Terlecki, director of the Men's Health Clinic at the Wake Forest Baptist Medical Center.

Among the flaws in the study, Terlecki said, was the use of information obtained from medical claims data, which makes it uncertain which men actually used the testosterone.

"This is important since compliance can be poor, especially with topical formulations," he said. Terlecki reported that he previously worked as a consultant for Auxilium, which makes testosterone therapy.

The researchers did not have information on why the testosterone therapy was prescribed, so it could have been prescribed inappropriately, Terlecki said. He also cited other data that has linked low testosterone -- not testosterone therapy -- to an increased risk of heart disease.

Men who are discussing testosterone therapy with their doctors "should add the risk of heart attack to the discussion of the risks and benefits of testosterone," Finkle said.

Terlecki said men who have a lack of energy should first see their doctor and ask about screening for depression and other conditions -- such as thyroid disease or B12 deficiency -- that could also be the cause.

Testosterone therapy is marketed so successfully that the independent medicine website Drugs.com reported that sales of Androgel exceeded sales of Viagra in 2013, according to UCLA researchers.

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