FDA Investigating Heart Attack and Stroke Risk From “Low-T” Therapy.
If Ponce de Leon was looking for the fountain of youth today, he wouldn’t go to Florida; he’d head to his doctor’s office for testosterone replacement therapy. However, recent studies showing that treatments for so-called “Low-T” might raise men’s risks for heart attacks, stroke, or death has led the Food and Drug Administration to begin investigating their safety and should give pause to anyone receiving or thinking about beginning testosterone replacement therapy.
An Explosion in Testosterone Therapy
Over the past five years, there has been an explosion in the number of men receiving treatments or prescriptions for “Low-T,” the natural decrease in men’s testosterone levels that occurs with aging. During that time, sales have gone up more than 500 percent and in 2013, sales of approved testosterone supplements outpaced the sale of Viagra, no doubt influenced by an advertising assault that rivals the barrage of ads for erectile dysfunction medication we’ve all become accustomed to.
Some of the more popular testosterone treatments include:
- Androgel – AbbVie Pharmaceuticals
- Androderm – Actavis Inc.
- Axiron – Eli Lilly & Company
- Bio-T-Gel – BioSante Pharmaceuticals/Teva Pharmaceutical Industries
- Delatestryl – Sandoz Canada Inc.
- Depo-Testosterone – Pfizer Inc.
- Fortesta – Endo Pharmaceuticals
- Striant – Actient Pharmaceuticals
- Testim – Auxilium Pharmaceuticals
- Testopel – Auxilium Pharmaceuticals
Some assert that doctors are overprescribing testosterone therapy, which typically comes in a gel, patch, or injection form, as more and more men look for a way to increase their sex drive or energy. CBSnews.com reported recently on a study that suggested 43 percent of men receiving testosterone already had normal levels of natural testosterone.
Risk of Heart Attack Doubles
The recent study that has spurred the FDA to act contained two important findings:
- For men over 65, the increase in the heart attack rate doubled soon after initiating testosterone therapy, and;
- In men under 65 with a history of heart disease, the risk of heart disease also doubled.
In announcing their investigation, the FDA told doctors that they “should consider whether the benefits of FDA-approved testosterone treatment is likely to exceed the potential risks of treatment.” Cautions about the risk of heart attack or testosterone stroke, however, are nowhere to be found on product labeling, though that may change in the future as a result of FDA action.
Call J. Alan Welch to Discuss Your Testosterone Therapy Concerns
As an attorney/pharmacist, I am currently investigating and keeping a close eye on developments and legal claims relating to testosterone-related heart attacks and strokes. If you or a loved one are concerned about the actual or potential harmful effects of your testosterone therapy, contact me today at (912) 265-9811 for a free, initial consultation to discuss your case.
This article has been prepared by J. Alan Welch Law for informational purposes only and does not, and is not intended to, constitute legal advice. The information is not provided in the course of an attorney-client relationship and is not intended to substitute for legal advice from an attorney licensed in your jurisdiction.