FDA Investigation of Low T Therapy

low testosterone lawsuit, low t lawsuit, low t lawyer. low t attorney, low testosterone lawyer, low testosterone attorney, low t law firm, low testosterone law firmTestosterone Low T therapy is on the rise and so goes the rise of a potential low t lawsuit.  Recently, the spotlight turns on the following – FDA investigating of low T therapy.
Prescription low testosterone Low T therapy is being used by aging men that may have “low T” (low testosterone levels) and are convinced that this “low T” is the source of many of their age-related problems.
Several studies in the last year have indicated that some problems may be associated with Low T therapy.  The FDA investigation of Low T therapy involves recent reports that Low T therapy may be associated with a possible risk of stroke, heart attack, and death in men taking FDA-approved testosterone products (e.g., androgel etc).  
The FDA release states that the FDA investigation of Low T therapy includes:
  • monitoring this risk and decided to reassess this safety issue based on the recent publication of two separate studies that each suggested an increased risk of cardiovascular events among groups of men prescribed testosterone therapy.
  • that the 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 first publication that prompted FDA to reassess the cardiovascular safety of testosterone therapy was an observational study of older men in the U.S. Veteran Affairs health system published in the Journal of the American Medical Association (JAMA) in November 2013.
    • The men included in this study had low serum testosterone and were undergoing imaging of the blood vessels of the heart, called coronary angiography, to assess for coronary artery disease. Some of the men received testosterone treatment
  • We urge health care professionals and patients to report side effects involving prescription testosterone products to the FDA MedWatch program, using the information in the “Contact FDA” box at the bottom of the page.

Some the potential problems that may be caused by low T or low testosterone therapy may include:

  • Stroke, which occurs when a blood clot reaches the brain and restricts oxygen supply
  • Pulmonary embolism, which happens when a blood clot lodges in the lungs
  • Blood Clot in the Deep Veins (Deep Vein Thrombosis or DVT)
  • Myocardial infarction (Heart Attack), commonly known as a heart attack – a sudden loss of blood flow in the heart
  • Arrhythmia, an irregular heartbeat
  • Transient ischemic attacks, or “mini-strokes,” as they are commonly called
  • Death

If you or your loved one has suffered a heart attack or stroke while on Androgel®, Androderm®, Fortesta®, Axiron®, Testim®, Bio-T-Gel®, Delatestryl®, Depo-Testosterone®, Striant®, and Testopel®– and you have any of these symptoms while on low testosterone or low t therapy and want to talk to a Low T lawyer and/or file a low testosterone lawsuit or low t lawsuit, contact us.


At the Gooch Law Firm, we pride ourselves on providing our clients reliable representation for even the most challenging cases.  If you or a man you know suffered a stroke, pulmonary embolism, heart attack, stroke, death or another serious cardiac event while undergoing testosterone low T therapy (e.g., androgel et al.) and would like your case evaluated, contact our office at 1.844.329.5955.