FDA Issues Testosterone Therapy Safety Alert

162017_132140396847214_292624_nOn January 31, 2014, the FDA issued a Safety Announcement regarding FDA-approved testosterone products. The FDA’s alert concerns the risk of stroke, heart attack, and death in men taking testosterone products that the FDA had previously approved; two recent studies suggest an increased risk of cardiovascular events among groups of men who had been prescribed testosterone therapy.

The testosterone products approved by the FDA were approved only for use in men who lack or have low testosterone levels in conjunction with an associated medical condition, such as the failure of the testicles to produce testosterone due to genetic problems or chemotherapy or problems with the hypothalamus and pituitary that control the production of testosterone by the testicles. The FDA has not approved testosterone products for use in men with low testosterone levels who lack an associated medical condition.

The FDA-approved testosterone products are formulated as a topical gel, transdermal patch, buccal system (applied to upper gum or inner cheek), or as an injection.

The Two Studies That Resulted In The FDA’s Testosterone Safety Alert

An observational study published in November 2013 in the Journal of the American Medical Association (JAMA) involved older men in the U.S. Veteran Affairs health system. These men were 60 years old on average and many had underlying cardiovascular disease. They had low serum testosterone and were having coronary angiography (imaging of the blood vessels of the heart) to assess for coronary artery disease.

Some of the men in the study had received testosterone treatment and some did not. The study reported a 30% increased risk of stroke, heart attack, and death in the group that had been prescribed testosterone therapy.

The second observational study reported an increased risk of heart attack in older men and also in younger men with pre-existing heart disease who filled a prescription for testosterone therapy. The study found a two-fold increase in the risk of heart attack among men aged 65 years and older in the first 90 days following the first prescription. Among men under age 65 who had a pre-existing history of heart disease, the study found a two-fold to three-fold increased risk of heart attack in the first 90 days following a first prescription. However, men under 65 who did not have a history of heart disease who filled a prescription for testosterone did not have an increased risk of heart attack.

The FDA’s Safety Announcement stated, “We are providing this alert while we continue to evaluate the information from these studies and other available data, and will communicate our final conclusions and recommendations when the evaluation is complete … We urge health care professionals and patients to report side effects involving prescription testosterone products to the FDA MedWatch program …”


If you or a family member underwent testosterone therapy and suffered a stroke, heart attack, or other cardiac event (including death), you should promptly consult with a local medical malpractice attorney in your U.S. state who may investigate your testosterone claim for you and represent you in a testosterone therapy lawsuit, if appropriate.

Click here to visit our website to be connected with testosterone claim lawyers (medical malpractice lawyers) in your state who may assist you with a testosterone therapy claim, or call us toll-free at 800-295-3959.

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This entry was posted on Sunday, February 2nd, 2014 at 9:48 am. Both comments and pings are currently closed.


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