FDA orders drug makers to change labels on Low Testosterone drugs

by Mandy Hicks

shots with bottlesEarlier this week, the Food and Drug Administration announced it is requiring the manufacturers of low testosterone drugs to change the labels of their products and to conduct further studies about the drugs. The FDA says some studies have indicated there is an increased risk of heart attack, stroke and even death while taking supplemental testosterone, while other studies have not. This has led the FDA to say that more research is needed by the manufacturers of the drugs as well as to require more warning labels on Low Testosterone drugs to better prepare doctors and patients for discussions about taking “Low T” drugs.

The FDA specifically called out clinics offering to treat the “signs of aging” in men which are often believed to be linked to gradually decreasing testosterone in the body. While decreasing testosterone may seem to be the culprit of fatigue or other similar problems, there’s not been enough research of the side effects of taking Low T drugs simply to fight the signs of aging. The FDA says the drugs should only be used in men who are suffering from low testosterone as a result of “disorders of the testicles, pituitary gland, or brain that cause a condition called hypogonadism.”

Health care providers should make patients aware of the risk of possible cardiovascular events and even death due to taking testosterone, the FDA says.

To find a list of drugs approved by the FDA to treat low testosterone, visit and type in the word testosterone in the search box. Among those used are Androderm, Androgel, Fortesta, Natesto, Axiron, Testopel, and Depo-Testosterone.

This isn’t the first time that Low-T drugs have come under scrutiny. In June 2014, the FDA required the manufacturers of low testosterone drugs to add a warning label to the products indicating there is an increased danger of venous blood clots while taking a testosterone drug.

If you or someone you love is taking a medication designed to boost testosterone, please speak with a physician. You may also want to know more about your legal rights. We are representing patients in Kentucky and Tennessee who have taken Low Testosterone drugs and experienced medical problems. Our drug injury attorneys can provide a free consultation for you or your family member if you are taking a low testosterone drug or have done so in the past. Please contact us at (270) 781-6500 or through our contact form.

More resources

CBS News story: FDA issues warning on testosterone-boosting drugs, March 4, 2015

NPR news story: FDA mandates tougher warnings on testosterone, March 3, 2015

Forbes story: FDA to testosterone makers: stop wooing average aging guys, March 3, 2015

Patients who have had a problem with a testosterone drug are encouraged to report the problems to the FDA here:

You can read the full statement by the FDA here:

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