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Testosterone drugs need study on heart risks, FDA panel says

September 18, 2014

Drugmakers, including Eli Lilly and Co., should conduct new trials to assess the heart risks of testosterone therapies used by millions of men last year, advisers to U.S. regulators said.

The Food and Drug Administration advisory panel voted 20-1 that drug developers should further assess the cardiovascular risks of testosterone products, with 16 panelists saying it should only be studied in some situations, Morgan Liscinsky, an FDA spokeswoman, said in an e-mail after the meeting.

The advisory panel also voted 20-1 that the FDA should revise who should be given the drugs, Liscinsky said. The advisers said little evidence exists that testosterone replacement therapies are effective for treating low levels of the hormone caused by aging, the Associated Press reported.

Use of testosterone products from AbbVie Inc., Lilly and others has soared in recent years. About 20 percent of patients on the treatments don’t have laboratory evidence showing they need them, according to an analysis of utilization data that FDA staff called “particularly concerning” in briefing documents.

Prescriptions for testosterone drugs have risen more than 58 percent since 2010, to 4.8 million last year, according to drug data firm, IMS Health, The Associated Press reported.

A study published in November suggested that testosterone replacement drugs boost the odds of a heart attack, stroke or dying by 29 percent. Other studies conflicted with the results, showing a decreased risk of mortality among testosterone users.

The panel’s recommendations would shrink the pool of patients eligible to take testosterone supplements, while drugmakers would have to do additional testing to determine whether the drugs pose cardiovascular risks. The agency isn’t required to follow its panels’ advice.

“Testosterone replacement therapy is an important men’s health topic. AbbVie is committed to our patients and we will work with the FDA during its review,” the North Chicago, Illinois-based company said in a written statement.

Lilly in an e-mailed statement, said that based on its assessment, current evidence does not support a causal link between testosterone therapy and serious cardiovascular events. “However, based on feedback from the committees, Lilly will collaborate with the FDA to determine how to communicate cardiovascular risk to patients,” it said.

Indianapolis-based Lilly had $179 million in sales last year for its treatment, called Axiron

Blockbuster product

Last year, market leader AbbVie reported $1.04 billion in sales of Androgel, a topical gel used to treat low testosterone. Auxilium Pharmaceuticals Inc. gained $271 million in 2013 for its Testim gel and Testopel, testosterone pellets implanted under the skin.

FDA advisers are scheduled to consider a new testosterone product. Closely held Clarus Therapeutics Inc. is seeking approval for Rextoro, which would be the first oral testosterone medicine in 50 years, according to the company.

Increasing use

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

Testosterone supplements have generated controversy in their use in older men. While the drugs help regulate development and maintenance of sexual characteristics in men who lack healthy levels of the hormone as a result of disease, it’s unclear whether they provide a similar benefit to males who take them to counteract testosterone declines caused by aging, FDA staff said.

It’s possible that as men grow older, replacing diminishing testosterone may provide few benefits such as warding off osteoporosis, increasing muscle mass and energy, while raising users’ risk of heart attack and other health complications, said FDA officials.

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