FDA Panel Votes for Strict New Label for Testosterone Drugs

A U.S. Food and Drug Administration (FDA) advisory panel voted overwhelmingly to impose new restrictions on testosterone drugs. The Panelists recommended on September 14th that the agency tighten labels and limit testosterone drugs to men with serious health conditions, such as pituitary gland problems.

More than 2.3 million men are taking testosterone drugs, but only a small percentage is treating a serious medical condition, according to the FDA. The majority of men taking testosterone drugs to treat low testosterone (Low-T) are treating symptoms brought on by aging, such as low energy and libido. Medical experts believe this alarming pattern is due to vague labeling, reported the New York Times.

If the FDA adopts the panels recommendations, the agency would not only tighten the criteria for Low-T prescriptions but would also clamp down on what panelists believe to be inappropriate marketing.

Some medical experts believe that the need for Low-T drugs is created by the manufacturers’ marketing efforts rather than medical necessity. “There is no such disease,” says Dr. Joel Finkelstein, a Harvard Medical School expert on male hormonal changes during aging. “The market for testosterone gels evolved because there is an appetite among men and because there is advertising. The problem is that no one has proved that it works and we don’t know the risks.”

The FDA is in the process of investigating testosterone risks and benefits. The agency launched an investigation in February 2014 after a number of reports suggested that users had an increased risk of suffering a heart attack or stroke. The FDA has not yet made a decision on testosterone heart attack and stroke risks, but a number of patients have filed testosterone lawsuits claiming they suffered a heart attack or stroke from testosterone.

Men who suffered a heart attack or stroke while taking Androgel, Axiron or another Low-T drug, and would like to file a lawsuit should contact a testosterone lawyer to find out if they are eligible.

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