Testosterone – Risk of Stroke, and Heart Attacks

The U.S. Food and Drug Administration (FDA) is investigating the risk of stroke, heart attack, and death in men taking FDA-approved testosterone products. The basis of the FDA’s action is two studies that have suggested that an increased risk of cardiovascular events among groups of men prescribed testosterone therapy.

One of those studies was conducted by the U.S. Veteran Affairs health system reported in the Journal of the American Medical Association (JAMA) in November 2013 and concluded that those who were taking a testosterone therapy had a 30 percent increased risk of stroke, heart attack, and death . The study involved imaging of the blood vessels of the heart, called coronary angiography, to assess for coronary artery disease.

 At this time, FDA has not concluded that FDA-approved testosterone treatment increases the risk of stroke, heart attack, or death. Patients should not stop taking prescribed

testosterone products without first discussing any questions or concerns with their health care professionals. 

Additional risks include:

• Possible increased risk of prostate cancer. Your healthcare provider should check you for prostate cancer or any other prostate problems before you start and while you use testosterone gel.

• In large doses testosterone gel may lower your sperm count.

• Swelling of your ankles, feet, or body, with or without heart failure.

• Blood clots in the legs or lungs

The U.S. Food and Drug Administration (FDA)issued a directive on June 2014 requiring manufacturers to include a warning in all approved testosterone products about the risk of blood clots in the veins. Blood clots in the veins, also known as venous thromboembolism (VTE), include deep vein thrombosis (DVT) and pulmonary embolism (PE).

For a discussion of the risks of testosterone therapy please see the Fox News video below.

Fox news Reports on FDA Investigates Testosterone