Testosterone Replacement Therapy

Testosterone Replacement Therapy (TRT) is used to treat problems which may arise due to inadequate production of testosterone in the human body. Testosterone is a hormone important in the proper development of male sexual characteristics and in maintaining muscle mass, adequate levels of red blood cells, bone growth and sexual function.

TRT is indicated for use by the FDA to treat men with either a diagnosis of Hypogonadism or Hypogonadotropic Hyponadism AND a diagnosis of low testosterone levels. In 2011, the Journal of American Medical Association (JAMA) reported that 5.3 million prescriptions were written for TRT. However, only half of the men using TRT had been diagnosed with either of the hypogonadism conditions for which TRT was approved for use by the FDA. The rest of the patients receiving TRT were diagnosed with other problems including fatigue or sexual dysfunction.

TRT seeks to treat the effects of testosterone deficiency, which can be done through a variety of methods such as injections, patches, gels, oral tablets, and implants. Numerous TRT products are currently on the market, including Androgel, Androderm, Axirom, Bio-T-Gel, Delatestryl, Depo-Testosterone, Fortesta, Striant, Testim, and Testopel.

Recent studies have linked to usage of TRT to a number of injuries including heart attack, strokes, pulmonary embolisms, and deep vein thrombosis (“DVT”).

Facts about TRT:

  • Studies reported in the last four years suggest the use of TRT is linked to a high risk of suffering from heart attacks, strokes, blood clots, and even death.
  • In 2010, The New England Journal of Medicine reported research on a trial conducted on 209 men, concluding that in many older men, the application of a testosterone gel was associated with an increased risk of cardiovascular-related adverse events.
  • In 2013, BMC Medicine reported on 1,882 studies, which included nearly 3,000 men, concluding that TRT increased the risk of cardiovascular-related events.
  • In November, 2013, JAMA published a study suggesting a 30-percent increased risk of stroke, heart attack, and death in a group of older men (average age= 60 years) using TRT.
  • In a 2014 study, PLOS One found that men aged 65 and older had double the risk of heart attack within 90 days of taking a testosterone gel, and younger men with a previous heart attack had triple the risk of a subsequent heart within 90 days of starting testosterone gel.

Litigation News:

  • On January 31, 2014, the U.S. Food and Drug Administration (“FDA”) announced plans to review TRT safety. The FDA is currently investigating the risk of stroke, heart attack and death in men taking FDA-approved TRT products.
  • To date, there have been a number of lawsuits filed by men who have experienced cardiovascular-related adverse events after taking TRT. Hundreds more are expected to be filed across the United States.

If you or a loved one has taken or is taking any TRT drug and suffers from a heart attack, pulmonary embolism, DVT, stroke, death or other cardiovascular-related injury, find out how Johnson//Becker PLLC can help you. Please either call us at our toll free number (800) 279-6386 or fill out our case review form here on our website, and submit it for a free consultation.