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FDA To Check Safety of Male Hormone Products

The Food and Drug Administration says it will check into the safety of testosterone-boosting products after the latest report confirming that supplementing the male hormone can double heart attack risk.

But in the meantime, men shouldn’t panic or stop taking prescribed testosterone without checking with their doctors, the FDA said.

“We have been monitoring this risk and decided to reassess this safety issue based on the recent publication of two separate studies that each suggested an increased risk of cardiovascular events among groups of men prescribed testosterone therapy,” the agency said in a statement.

“At this time, FDA has not concluded that FDA-approved testosterone treatment increases the risk of stroke, heart attack, or death. Patients should not stop taking prescribed testosterone products without first discussing any questions or concerns with their health care professionals.”

A study published this week showed men with heart disease double their risk of heart attack soon after they start using testosterone gels or other supplements. And testosterone doubled the risk in men over 65 with or without heart disease.

The study, published in the Public Library of Science journal PLoS ONE, confirmed the results of several smaller studies. One published in November found that the use of "low T" therapy boosted the risk of serious problems including heart attack, stroke and death in men who already had heart trouble and who had low testosterone.

“Testosterone is a hormone essential to the development of male growth and masculine characteristics,” the FDA said.

“Testosterone products are FDA-approved only for use in men who lack or have low testosterone levels in conjunction with an associated medical condition. Examples of these conditions include failure of the testicles to produce testosterone because of reasons such as genetic problems or chemotherapy. Other examples include problems with brain structures, called the hypothalamus and pituitary, that control the production of testosterone by the testicles,” it added.

But hormone products are being heavily promoted for non-medical reasons including sleepiness after dinner and lower libido.

“None of the FDA-approved testosterone products are approved for use in men with low testosterone levels who lack an associated medical condition,” FDA pointed out.

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