19 Feb 2014

FDA Investigating Link Between “Low T” Treatments and Heart Attacks and Strokes

If you’ve watched TV or read a newspaper or magazine over the past few years, you’ve no doubt seen a barrage of ads discussing the issue of low testosterone in men, or what the pharmaceutical companies’ marketing departments have dubbed “Low T.” These ads pitch all kinds of treatments for low testosterone, promising increased energy, sex drive, and stamina.

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.


Bigger Than Viagra

The marketing campaign for “Low T” therapy has clearly worked. Over the past five years, sales for treatments or prescriptions designed to reverse the natural decrease in men’s testosterone levels that occurs with aging have gone up more than 500 percent. In fact, in 2013, sales of approved testosterone supplements outpaced the sale of Viagra.


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. A recent study suggested that 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:


1. For men over 65, the increase in the heart attack rate doubled soon after initiating testosterone therapy, and;


2. 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 Kendall Law Firm, PLLC to Discuss Your Low T Concerns

If you or a loved one are concerned about the actual or potential harmful effects of your testosterone therapy and want to discuss potential claims arising out of those effects, we welcome the opportunity to talk about your case. At Kendall Law Firm, we will carefully listen to your story and help you determine if you have a potential claim. Call us today at 479-464-9828 to discuss your case.


This article has been prepared by Kendall Law Firm, PLLC 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.

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