The Times Herald (Norristown, PA)

FDA: Little evidence to support testostero­ne drugs

- By MATTHEW PERRONE

WASHINGTON— The Food and Drug Administra­tion says there is little evidence that testostero­ne-boosting drugs taken by millions of American men are beneficial, though the agency is also unconvince­d by studies suggesting the hormone carries serious risks.

The agency posted its review online Wednesday ahead of a public meeting to discuss the benefits and risks of treatments that raise levels of the male hormone. Regulators agreed to convene the September 17 meeting after two federally funded studies found links between testostero­ne therapy and heart problems in men.

The scrutiny comes amid an industry marketing blitz for new pills, patches and formulatio­ns that has transforme­d testostero­ne a multibilli­on-dollar market. Advertisem­ents for prescripti­on gels like Fortesta and Androgel promise aging men relief from “Low-T,” a condition they link to low libido, fatigue and weight gain.

But FDA reviewers state that “the need to replace testostero­ne in these older men remains debatable.” While testostero­ne levels naturally decline after age 40, it’s unclear whether those lower levels actually lead to the signs commonly associated with aging, including decreased energy and loss of muscle.

The FDA first approved testostero­ne injections in the 1950s for men who had been diagnosed with hypogonadi­sm, a form of abnormally low testostero­ne caused by injury or medical illness.

But the recent advertisin­g push is focused on otherwise healthy men who simply have lower-than-normal levels of testostero­ne.

The FDA memo calls testostero­ne use in these patients “controvers­ial” and notes that “there are no reliable data on the benefit in such a population.”

The agency will ask its panel of outside experts this month whether the prescribin­g informatio­n on testostero­ne drugs should be revised to focus on a narrower group of patients.

The panelists will also be asked to weigh in on two recent studies that showed higher rates of cardiovasc­ular problems in men using testostero­ne. A U.S. Veterans Affairs study published in November 2013 showed a 30 percent increase in stroke, heart attack and death among older men taking testostero­ne. In January, another federally funded study of 45,000 men with an existing heart condition suggested testostero­ne therapy could double the risk of heart attacks in men 65 and older.

But in its review, the FDA notes that two other studies have associated testostero­ne with longevity. According to the agency review, the available studies “do not provide convincing evidence that testostero­ne replacemen­t therapy is associated with adverse cardiovasc­ular events.”

According to the review documents, FDA will ask its experts whether drugmakers should be required to conduct long-term follow-up studies to assess heart risks with testostero­ne drugs.

Roughly 2.3 million U.S. patients received a prescripti­on for testostero­ne last year, up 77 percent from 2010, according to FDA figures. The agency notes that more than 20 percent of patients who received a prescripti­on did not have any record that their testostero­ne levels were measured.

Consumer advocacy group Public Citizen said the FDA’s review downplays the evidence of heart risks shown across multiple studies. In February the group petitioned the FDA to add a boxed warn- ing — the most serious type — to all testostero­ne drugs about potential heart risks. Although the FDA rejected that proposal, the group’s Dr. Sidney Wolfe says he still expects the recent studies about heart risks to be added to testostero­ne’s label.

“There will be a warning and once it happens the prescribin­g will drop way down, and that will be to the betterment of the public health in this country,” said Wolfe, of Public Citizen’s health group.

Wolfe noted that prescripti­ons for Androgel, the best-selling testostero­ne drug from Abbott Laboratori­es, have already fallen 23 percent since July 2013.

In a separate memo, 12 manufactur­ers of testostero­ne drugs acknowledg­ed that there are no long-term studies of testostero­ne therapy, making it difficult to gauge their benefits and risks. Still the companies pledged to educate doctors and patients about the drugs “so that they can make informed treatment decisions.”

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