FDA Restricts Age-Related Testosterone Drug Use

According to researchers at the Food and Drug Administration (FDA), drugs that boost testosterone levels in men may fail to effectively treat age-related low testosterone.

Since several recent studies have linked testosterone-raising medication to heart complications in men, the FDA met on Wednesday to dialogue about the risks and benefits of the drugs.
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“There's no way testosterone would be approved for the treatment of age-related low-T today, by contemporary regulatory standards,” said Dr. John Teerlink, FAAC, FAHA, FESC, FRCP, of the FDA panelists and professor of medicine at the University of California, San Francisco.

“We have no evidence of any benefit for patients and we have questions about clinical safety,” he said.

Advisors from the FDA panel voted (20-1) for future labeling on testosterone treatments to be clear about not reversing symptoms of age-related low-t, such as fatigue, low-libido, and muscle loss.

According to experts, the change of labeling would only affect men with low-t related to aging, and not men exhibiting low hormone levels because of injury or disease.

The complete report is published on the FDA’s website.

-Michelle Canales

References:

FDA. Joint meeting for bone, reproductive and urologic drugs advisory committee (BRUDAC) and the drug safety and risk management advisory committee (DSARM AC). September 17, 2014. www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/ReproductiveHealthDrugsAdvisoryCommittee/UCM412536.pdf. Accessed September 18, 2014.

The Associated Press. Experts Want Restrictions on Testosterone Drug Use. September 17, 2014. Accessed September 18, 2014.