FDA Issues Drug Safety Advisory for Increased Risk of Heart Attack and Stroke with Testosterone Drugs
NOTE: BURG SIMPSON IS NOT PURSUING NEW LOW T/TESTOSTERONE THERAPY CASES
The FDA today announced that it will require manufacturers of testosterone replacement therapy products to update labeling to:
- Warn of a possible increased cardiovascular risk associated with testosterone use.
- Clarify that testosterone has not been evaluated to treat low testosterone levels due to aging.
This FDA advisory affects all of the testosterone replacement therapies sold in the U.S., including:
- AndroGel
- Androderm
- Axiron
- Delatestryl
- Fortesta
- Striant
- Testim
- Testopel
After reviewing medical studies and seeking input from experts on the FDA’s Advisory Committee, the FDA announced a possible increased risk of cardiovascular risk associated with testosterone use. Drug makers are required to change the labeling for testosterone drugs to warn doctors and patients about this increased risk.
Medical studies published in the Public Library of Science and The Journal of the American Medical Association have shown that testosterone therapy is associated with an increased risk of cardiovascular injuries such as heart attack and stroke.
