FDA Will Investigate Approved Testosterone Therapies for Heart Link
The Food and Drug Administration (FDA) issued a statement on Friday, January 31st, that the agency will investigate reported risks for heart attack and stroke associated with testosterone therapy.
The statement was spurred by two recently published studies involving low testosterone – one published in the Journal of the American Medical Association, the other published in PLoS One. Both studies concluded that testosterone therapy, which is prescribed for a variety of problems from low energy to low sex drive, increases the risk of heart attacks and strokes in various groups of men.
The JAMA study followed 8,700 men nationally, men who underwent testosterone therapy were 30% more likely to have a heart attack or stroke, or die from a cardiac episode, during a three-year period than men with low testosterone who did not take supplements. Most of the men involved in the study had other problems such as high blood pressure, unhealthy cholesterol levels, and diabetes, and all the participants were in their 60’s or older. Nearly 26% of the participants using testosterone therapy had one of the potential bad outcomes during the course of the three-year study, compared to 20% of nonusers.
The most recent study, published in PLoS One, followed 56,000 men – 48,000 of whom were under 65 – for 90 days while they underwent testosterone therapy. The study concluded that the risk of heart attack for men over 65 years of age doubled in the short 3-month time span after they began testosterone therapy, as well as for the men under 65 years old who had a history of heart disease. This study was the first, according to the study’s authors, to look at the incidence of heart attacks and strokes in men under the age of 65.
In response to these two studies, the FDA has agreed to conduct studies on testosterone therapy which the agency has approved for use. According to their statement: “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.”
So far, none of the studies looking at the potential risks of testosterone therapy have included what causes the increased risk of heart attack or stroke. “The theory is that testosterone most likely promotes clotting,” said William Finkle, CEO of Consolidated Research, which conducted the PLoS One study. In older men who tend to have thinner vessels, that clotting could cause problems. However, some researchers have suggested that a build-up of estrogen in response to the influx of testosterone could also lead to clotting problems.
According to Dr. Ryan Terlecki, director of the Men’s Health Clinic at the Wake Forest Baptist Medical Center, it is possible that doctors are prescribing testosterone therapy to inappropriate patients. Terlicki suggested that men with low energy ask to be screened for other possible causes, including depression and vitamin B12 deficiency.
The Strom Law Firm Can Help with Dangerous Drug Cases, Including Testosterone Therapy and Supplements
Strom Law Firm, L.L.C. is a leader in the consumer protection battle against dangerous prescription drugs and medical devices, from Actos to testosterone therapy. We represent individuals who have been killed or injured by dangerous or defective pharmaceuticals. If you or a family member have been injured or killed after using a dangerous drugs or medical products such as testosterone therapy or supplements, contact our dangerous drug lawyers as soon as possible so that we can begin taking steps to preserve evidence and your claim immediately. We offer free consultations to discuss the facts of your case. 803.252.4800