Possible Heart Risk With Testosterone Spurs Debate on Use

Testosterone supplements used last year by about 2.3 million men are spurring debates over how necessary and safe they may be, even as U.S. regulators consider approving a new product.

Food and Drug Administration advisers tomorrow will consider whether the drugs are being prescribed to the right people. They also will weigh whether the labels should change to reflect heart risks suggested by some studies, according to FDA briefing documents.

The number of men taking testosterone supplements grew by 1 million between 2010 and last year, when AbbVie Inc.s Androgel, the market leader, generated $1.04 billion in sales. At the same time, 21 percent of patients didnt have evidence of laboratory testing before taking the supplements, according to an analysis of utilization data that the FDA staff called particularly concerning in its briefing document.

We dont expect there will be a major change in the labels for these drugs, said Eric Schmidt, an analyst at Cowen & Co., in a telephone interview. But if there were a major negative change to the prescribing materials, you could see a more substantial impact.

While testosterone replacement therapy has been approved in the United States since 1950 for men with medical conditions leading to deficiencies, such as testicular damage due to chemotherapy, use has surged in men who have low testosterone for no other reason than age, the FDA document said.

Other sellers of testosterone products include Indianapolis-based Eli Lilly & Co. (LLY), which had $179 million in sales last year for its treatment, called Axiron; and Auxilium Pharmaceuticals Inc. (AUXL), which gained $271 million in 2013 for its Testim gel and Testopel, testosterone pellets implanted under the skin.

The newest product is Rextoro, made by closely-held Clarus Therapeutics Inc. The company is seeking approval for what would be the first oral testosterone medicine in 50 years, according to the drugmaker. The FDA advisers will consider the product on Thursday.

We are looking forward to participating in the FDA Advisory Committee meeting, said Keri Mattox, a spokeswoman for Auxilium, in an e-mail. Next steps for the industry will depend upon the outcome of the meeting.

Its premature to speculate on the impact at this juncture, said Celeste Stanley, an Lilly spokeswoman, in a telephone interview. AbbVie spokeswoman Libby Holman declined to discuss the possible outcomes of the FDA meeting.

So far, data on the drugs cardiovascular effects have been limited and conflicting, the FDA said.

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Possible Heart Risk With Testosterone Spurs Debate on Use

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