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Testosterone Replacement Therapy

Testosterone Replacement Therapy and the Risk of Heart Attack and Stroke

The Journal of the American Medicine Association published a study in November of 2013 warning of a 29 percent increased occurrence of strokes and heart attacks in men who take testosterone replacement drugs. The medical journal PLOSOne published a similar study in January of 2014 concluding that "the evidence supports an association between testosterone therapy and risk of serious, adverse cardiovascular-related events–including non-fatal myocardial infarction–in men." As the result of these studies and other data, the FDA has announced that they will reevaluate the side effects and the safety of testosterone therapy.

In February of 2014 five lawsuits were filed by users of the testosterone drug, AndroGel. These five men claim that they experienced cardiac events after using Androgel. The suit is against Abbott Laboratories and AbbVie Inc. (a spin-off company of Abbott), and it alleges that these pharmaceutical companies concealed knowledge of the potential harmful effects of Androgel.

The FDA has approved Androgel and similar testosterone therapy drugs, but only for men with low testosterone levels due to a medical condition called hypogonadism. However, since Androgel and other testosterone treatments were introduced, the market has exploded into a $2 billion business. According to Consumer Reports, pharmaceutical companies spent nearly $100 million in 2012 on promotional expenses associated with testosterone drugs, up from $14 million spent in 2011.

The increase in testosterone drug sales results, in part, from aggressive consumer marketing campaigns (advertising) by the drug manufacturers. Increasingly these marketing campaigns are targeting men who do not have hypogonadism. Instead, the drug companies are advertising to men who simply have "low-T" or lower testosterone levels, often due to the natural aging process. Doctor’s can legally prescribe "low-T" drugs for purposes other than hypogonadism - this is called off-label prescribing – but a pharmaceutical company (drug company) can NOT legally market a drug for something other than its FDA approved purpose.

Testosterone is a hormone that occurs naturally in a male’s body. However, the aging process and certain medical conditions can lead to decreased or low levels of testosterone resulting in symptoms such as:

  • Diminished sex drive
  • Sexual dysfunction
  • Lack of energy
  • Weight gain
  • Depressed mood
  • Decrease in muscle mass and bone strength
  • Loss of body hair

It is important to work with a doctor to determine the cause of low testosterone levels. A physician will run a blood test and consult with the patient to come up with a diagnosis. If a doctor recommends the use of a testosterone therapy, it is worth discussing the side effects and risks of testosterone drugs. In addition to these new concerns about increased risks of cardiac events, "low-t" drugs also carry risks of blood clots, anemia, prostate cancer and risks of secondary exposure to children and women.

Current testosterone drugs on the market include:

  • Androderm
  • AndroGel
  • Axirom
  • Delatestryl
  • Depo-Testosterone
  • Fortesta
  • Striant
  • Testim
  • Testope

If you or someone in your family has had a heart attack or stroke that you believe arose from the use of the AndroGel or another testosterone drug, you should consider contacting an attorney to evaluate your case. An attorney can help you to determine if your case warrants investigation. Pleasecontact Brett H. Oppenheimer, PLLC, who can help to guide you through the evaluation.

Call (502) 242-8877 for a free consultation about your experience with testosterone therapy.

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