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FDA Committees to Address Safety of Testosterone Products

Meeting scheduled for September

The FDA has called for a joint meeting of its Bone, Reproductive, and Urologic Drugs Advisory Committee and its Drug Safety and Risk Management Advisory Committee to discuss the appropriate indicated population for testosterone replacement therapy and the potential for adverse cardiovascular outcomes associated with this use.

The meeting is scheduled for September 17.

In January 2014, the FDA announced that it was investigating the risk of stroke, heart attack, and death in men taking FDA-approved testosterone products. The agency had been monitoring this risk and decided to reassess the issue based on the publication of two separate studies that each suggested an increased risk of cardiovascular events among men prescribed testosterone therapy. At that time, the FDA had not concluded that agency-approved testosterone treatment increases the risk of stroke, heart attack, or death.

The first publication that prompted the FDA to reassess the cardiovascular safety of testosterone therapy was an observational study of older men in the U.S. Veteran Affairs health system published in JAMA in November 2013. The men included in this study had low serum testosterone and were undergoing coronary angiography to assess for coronary artery disease. Some of the men received testosterone treatment, while others did not. On average, the men who entered the study were approximately 60 years old, and many had underlying cardiovascular disease. This study indicated a 30% increased risk of stroke, heart attack, and death in the group that had been prescribed testosterone therapy.

A second observational study reported an increased risk of heart attack in older men, as well as in younger men with pre-existing heart disease, who filled a prescription for testosterone therapy. This study reported 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 younger men less than 65 years old with a pre-existing history of heart disease, the study reported a two- to three-fold increased risk of heart attack in the first 90 days following a first prescription. Younger men without a history of heart disease who filled a prescription for testosterone, however, did not have an increased risk of heart attack.

In June, the FDA required manufacturers to include a general warning in the drug labeling of all approved testosterone products about the risk of venous thromboembolism (VTE), which includes deep vein thrombosis and pulmonary embolism. The risk of VTE is already included in the labeling of testosterone products as a possible consequence of polycythemia, which sometimes occurs with testosterone treatment.

Because there had been post-marketing reports of VTE unrelated to polycythemia, the FDA required a change to the drug labeling for all testosterone products to provide a more general warning regarding VTE and to ensure that this risk is described consistently in the labeling of all approved testosterone products.

Because VTE occurs in the veins, the new warning was not related to the FDA’s ongoing evaluation of the possible risk of stroke, heart attack, and death in patients taking testosterone products.

Testosterone is a hormone essential to the development of male growth and masculine characteristics. Testosterone products are FDA-approved only for use in men who lack or have low testosterone levels in conjunction with an associated medical condition, such as failure of the testicles to produce testosterone because of genetic problems, chemotherapy, or other problems.

Testosterone products on the market or about to be launched include AndroGel (AbbVie), Aveed (Endo International), and Natesto (Trimel Pharmaceuticals).

Sources: FDA; July 17, 2014; Reuters; July 17, 2014; FDA; June 9, 2014; and FDA; January 31, 2014.

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