Testosterone Replacement Therapy

On January 31, 2014, the U.S. Food and Drug Administration (FDA) issued a Safety Alert stating that it is "investigating the risk of stroke, heart attack, and death in men taking FDA-approved testosterone products."  The Safety Alert follows an article published in the November, 2013 issue of the Journal of the American Medical Association (JAMA), which reported a link between testosterone replacement therapy (TRT) and an increased risk for adverse outcomes and/or Low-T therapy side effects, including:

  • heart attack (i.e., myocardial infarction);
  • blood clots (e.g., deep vein thrombosis, pulmonary emboli);
  • stroke; and
  • sudden death.

Specifically, among the 8,700 patients in the study, men on testosterone replacement therapy experienced complications at a rate 29% higher than those who did not receive TRT.  Testosterone is a hormone essential to the development of male growth and masculine characteristics.  TRT, which is sometimes called androgen replacement therapy, comes in several forms including pills, injections, gels and patches.  The treatment is intended to boost or supplement a patient's hormone levels and is sold under the brand names:

While the FDA did not recall TRT, originally marketed as a safe treatment for men with low testosterone, there is growing concern among critics that TRT has been over-prescribed to men with testosterone that is not consistently below 300 ng/dL, and to men who have never had their testosterone levels tested.

The trial lawyers at Bottar Leone, PLLC, have decades of experience investigating, prosecuting and trying to verdict dangerous pharmaceutical and unsafe drug cases.  If you or a loved one have been injured due to the consumption of a prescription medication, you and your family may be entitled to compensation for lifelong health care, medical expenses, special education, medical bills, loss of income, and pain and suffering. 

To discuss your case or concerns with an experienced upstate New York testosterone lawsuit attorney, contact us now at (315) 422-3466, (800) 336-LAWS, or by e-mail at info@bottarleone.com.