March 18, 2015
FDA Orders Changes on Prescription Testosterone Labels

Washington, DC—The FDA is requiring that labeling on prescription testosterone products now clarify for what conditions the medication should be used and caution about a possible increased risk of heart attacks and strokes.

In announcing the changes, the FDA emphasized that prescription testosterone products are approved only for men who have low testosterone levels caused by certain medical conditions, adding, “The benefit and safety of these medications have not been established for the treatment of low testosterone levels due to aging, even if a man’s symptoms seem related to low testosterone.”

Before prescribing testosterone, the conditions should be confirmed by laboratory testing, the FDA added.

Androgen replacement therapy is only approved for men who have low testosterone levels due to disorders of the testicles, pituitary gland, or brain that cause hypogonadism. Examples of these disorders, according to the FDA, include failure of the testicles to produce testosterone because of genetic problems, or damage from chemotherapy or infection.

Government regulators said they had become aware, however, “that testosterone is being used extensively in attempts to relieve symptoms in men who have low testosterone for no apparent reason other than aging. The benefits and safety of this use have not been established.”

The FDA said it also has concluded that the possibility exists for increased cardiovascular risk associated with testosterone use, based on studies included aging men undergoing the treatment. A Drug Safety Communication noted that some studies reported an increased risk of heart attack, stroke, or death associated with testosterone treatment, while others did not.

“Based on our findings, we are requiring labeling changes for all prescription testosterone products to reflect the possible increased risk of heart attacks and strokes associated with testosterone use,” the FDA said, urging healthcare professionals to make patients aware of the possible risk when deciding whether to start or continue a patient on testosterone therapy.

Manufacturers of approved testosterone products also are being required to conduct clinical trials to provide more data on whether an increased risk of heart attack or stroke exists among users of testosterone replacement products.

“We are encouraging these manufacturers to work together on a clinical trial, but they are allowed to work separately if they so choose,” according to the FDA announcement.

U.S. Pharmacist Social Connect