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Testosterone drugs under FDA review for heart-attack risk

February 3, 2014

Testosterone drugs, which make up a growing market for pharmaceutical companies, are getting a closer look from U.S. regulators after two separate studies found an increased risk of heart attack, stroke and death in men who took the therapies.

The Food and Drug Administration said in a statement Friday that it will review the safety risk of testosterone drugs to see whether they increase the possibility of such harm. The agency said it has been evaluating the risk of the treatments and decided to reassess its analysis given the recent data.

“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,” the FDA said.

Treatments include Axiron, a topical solution applied under men’s arms from Eli Lilly and Co., and AbbVie Inc.’s AndroGel, which is applied on shoulders and upper arms. The market for the drugs is worth $1.6 billion.

U.S. sales of Axiron were $257 million for the 12 months ended Sept. 30, 2013

A study released in November of more than 8,000 men treated in the U.S. Veterans Affairs health system found testosterone therapy raises men’s risk of heart attack, stroke and dying by 29 percent. While the study didn’t identify reasons for the increased risk, testosterone worsens sleep apnea and affects blood platelets, linked to atherosclerosis and coronary plaque.

Prescriptions for the supplements rose more than fivefold, to 5.3 million in 2011 from 2000, the authors said. The products are only FDA-approved for men who lack or have low testosterone levels in conjunction with an associated medical condition such as failure to produce the hormone because of genetic problems or chemotherapy, the agency said.

The FDA advised patients not to stop taking the drugs and talk to their doctor.

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