The U.S. Food and Drug Administration (FDA) is investigating the safety of certain testosterone products after two studies suggested increased risk of heart attack, stroke, and death.
In a statement, the FDA noted that its investigation pertains to FDA-approved testosterone treatments that are prescribed for men with associated medical conditions. Such conditions include problems with the testes, hypothalamus, or pituitary gland that can inhibit testosterone production.
The first study that caught the FDA’s attention was published in November in the Journal of the American Medical Association (JAMA). This observational study involved approximately 8,700 older men in the U.S. Veteran Affairs health system. These men had low testosterone levels and were undergoing coronary angiography. Later, about 1,200 of the men began testosterone therapy. The researchers found a 30% increase in the risk of stroke, heart attack, and death in this subgroup of men.
The second study, published in PLOS One in late January, was a cohort study that included approximately 56,000 men on testosterone therapy. The researchers examined the risk of non-fatal heart attack in the 90 days following the men’s first testosterone prescription. They reported a two-fold increase in this risk for the men aged 65 and over. Men younger than 65 with a history of heart disease had a two- to three-fold increase in risk. Younger men with no history of heart disease were not at increased risk.
In a safety announcement dated January 31, the FDA wrote, “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. Health care professionals should consider whether the benefits of FDA-approved testosterone treatment is likely to exceed the potential risks of treatment.”
The FDA will announce its final conclusions and recommendations after the investigation is finished.
Resources
HealthDay
Doheny, Kathleen
“Testosterone Therapy Might Increase Heart Attack Risk: Study”
(January 29, 2014)
http://consumer.healthday.com/cardiovascular-health-information-20/heart-attack-news-357/testosterone-therapy-boosts-heart-attack-risk-study-684334.html
Journal of the American Medical Association
Vigen, Rebecca, MD, MSCS, et al.
“Association of Testosterone Therapy With Mortality, Myocardial Infarction, and Stroke in Men With Low Testosterone Levels”
(Full-text. November 6, 2013)
http://jama.jamanetwork.com/article.aspx?articleid=1764051&resultClick=3
MedPage Today
Fiore, Kristina
“FDA to Investigate Testosterone Risk”
(January 31, 2014)
http://www.medpagetoday.com/Endocrinology/GeneralEndocrinology/44081
Medscape
O’Riordan, Michael
“FDA Now Investigating CVD Risks With Testosterone Therapy”
(January 31, 2014)
http://www.medscape.com/viewarticle/820053
The New York Times
O’Connor, Anahad
“New Concern About Testosterone and Heart Risks”
(January 29, 2014)
http://well.blogs.nytimes.com/2014/01/29/study-adds-to-concern-about-cardiac-risks-for-older-men-taking-testosterone/
PLOS One
Finkle, William D., et al.
“Increased Risk of Non-Fatal Myocardial Infarction Following Testosterone Therapy Prescription in Men”
(Full-text. January 29, 2014)
http://www.plosone.org/article/info%3Adoi%2F10.1371%2Fjournal.pone.0085805#abstract0
Sexual Medicine Society of North America
“Overview – Low Testosterone”
http://www.sexhealthmatters.org/low-testosterone/overview-low-testosterone
U.S. Food and Drug Administration
“FDA evaluating risk of stroke, heart attack, and death with FDA-approved testosterone products”
(Safety Announcement. January 31, 2014)
http://www.fda.gov/downloads/Drugs/DrugSafety/UCM383909.pdf
“Testosterone Products: Drug Safety Communication – FDA Investigating Risk of Cardiovascular Events”
(January 31, 2014)
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm384225.htm