Motley Rice is actively litigating cases involving patients who suffered from serious complications, including heart attacks and strokes, while taking testosterone replacement therapy.
If you or someone you know suffered from one or more of these conditions while undergoing testosterone replacement therapy, contact Motley Rice prescription drug attorney John Duane by email or call 1.800.768.4026.
Testosterone Product Side Effects
On March 3, 2015, the FDA announced “that there is a possible increased cardiovascular risk associated with testosterone use” and is now requiring all prescription testosterone product manufacturers to update their labeling “to reflect the possible increased risk of heart attacks and strokes associated with testosterone use.”
On June 19, 2014, the FDA alerted testosterone product manufacturers that they are required to include a general warning about the risk of blood clots in veins on all drug labels. Also known as venous thromboembolism (VTE), deep vein thrombosis (DVT) and pulmonary embolism (PE), venous blood clots not associated with an abnormal increase in red blood cells (a warning already included on labeling) have been reported to the FDA, prompting the new label requirement. The FDA added that “because these clots occur in the veins, this new warning is not related to FDA’s ongoing evaluation of the possible risk of stroke, heart attack, and death in patients taking testosterone products.”
On Jan. 31, 2014, the FDA issued an alert announcing that it was investigating the risk of stroke, heart attack and death in men taking FDA-approved testosterone products due to the release of two separate studies that suggest an increased risk of cardiovascular events among men taking prescribed testosterone therapy.
What is testosterone?
According to the Mayo Clinic, testosterone is a hormone produced primarily in the testicles. Testosterone helps maintain men's:
- Bone density
- Fat distribution
- Muscle strength and mass
- Red blood cell production
- Sex drive
- Sperm production
What is testosterone replacement therapy?
Testosterone replacement therapy is prescribed for men to combat the natural decline in testosterone as they age. Testosterone replacement therapy is approved specifically for the treatment of abnormally low testosterone levels, a condition called hypogonadism and commonly called “low T.” The hormone helps build muscle, reduce body fat and improve sex drive. According to news reports, more than 5 million prescriptions for testosterone were written in the United States in 2011 alone. Testosterone therapy is most often administered as a gel, patch or injection.
Studies about Low T Therapy
Recent studies have linked prescription testosterone use with the increased risk of heart attacks, strokes and even death.
The Journal of the American Medical Association (JAMA) reported a link between testosterone supplements and an increased risk of death, heart attack and stroke in a November 2013 study. The JAMA study examined the health records of more than 8,700 men with low testosterone (defined as below 300 nanograms per deciliter) who had coronary angiography—a test to determine plaque buildup in blood vessels—in the Veterans Health Administration system between 2005 and 2011. The study found that those who used testosterone supplements were about 30 percent more likely to have a heart attack, stroke, or die after three years of use. Of the men, 1,223 had testosterone therapy and nearly 26% of them suffered a heart attack, stroke or died for a reason included in the study within the following three years compared with 20% of those not taking testosterone. Many of the men in both groups had a history of heart attacks, diabetes or coronary artery disease, although those taking testosterone were slightly younger and had lower rates of other illnesses.
Alarmingly, the researchers found that men who started the study with clear coronary arteries were just as likely to have a heart attack, stroke or die as men who entered the study with established coronary artery disease. This difference could be seen even after the researchers took into account age, blood pressure, the presence of heart disease and other factors.
Bloomberg (March 3, 2015): FDA orders testosterone label limits, heart attack warnings
Reuters (June 20, 2014): FDA asks for wider warnings on testosterone products
ABC News (Nov. 5, 2013): Testosterone supplements tied to heart attacks, stroke, early death