Testosterone Drugs for "Low-T" Investigated by the FDA

 Posted on May 28, 2014 in FDA

Men across the country are subjected to television and radio ads selling drugs that treat Low-T levels in the body. Men are told that their low libido, lack of energy, and inability to play sports can be fixed with testosterone drugs. Now, the FDA is examining issues that include an increased risk of heart attacks in men who receive testosterone treatments for their Low-T.

Testosterone treatments have been approved by the FDA, but in a recent press release, the agency said that it has opened an investigation into the side effects of the drugs.

“At this time, FDA has not concluded that FDA-approved testosterone treatment increases the risk of stroke, heart attack, or death,” the FDA announced in its press release. “Patients should not stop taking prescribed testosterone products without first discussing any questions or concerns with their health care professionals. None of the FDA-approved testosterone products are approved for use in men with low testosterone levels who lack an associated medical condition.”

The medical journal PLOS ONE published a recent study that links heart issues with testosterone treatments. The study found that men age 65 and older have a two-fold increase of heart attack just 90 days after beginning treatment for Low-T. Men younger than 65 who have previous history of heart issues have a “two-to-three fold” risk of heart attack after beginning treatment. Younger men with no history of heart issues did not experience an increased risk following treatment.

The FDA has approved testosterone drugs for men who cannot produce enough testosterone naturally. This can occur due to chemotherapy, genetics, and the failure of the testicles to produce testosterone.

The Journal of the American Medical Association published a survey that originally caused the FDA to investigate these drugs. This study examined more than 8,000 veterans who struggled with low testosterone levels and received treatment. Of this group, some 1,200 men aged 60 or older had a 30 percent increased risk of heart attack, stroke, and death. This is compared to men who were not given additional testosterone.

Please contact an Illinois defective medical device attorney today if you or a loved one has suffered heart problems due to testosterone treatments.