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Are Testosterone Replacement Treatments Safe?

Low testosterone therapy has been increasingly prescribed in recent years, resulting in billions of dollars of contributions to the pharmaceutical industry. This type of hormone treatment is typically used in men with low testosterone levels who suffer from decreased libido, low energy, lack of motivation, depression, and irritability. However, recent studies show that potentially dangerous consequences may arise as a result of low testosterone therapies, which include gels, patches, injections, and implants.

Over 2,000 lawsuits have been filed against numerous drug companies manufacturing “Low T,” including Auxilium and Endo Pharmaceuticals. The latest is a 2015 wrongful death suit filed in Illinois against the makers of AndroGel, AbbVie, Inc. The plaintiff claims that exposure to the gel triggered a heart attack that resulted in her husband’s death. She alleges that AbbVie is guilty of:

  • Negligent design of a defective drug
  • Not warning consumers of potential dangers
  • Mis-representing the safety of the drug.

While courts await 2016 trials, anyone participating in or potentially injured by low testosterone therapies should be aware of the risks.

What Numerous Studies Reveal About Heart Attack Risk

  • A recent study of approximately 56,000 men showed that patients over 65, as well as younger men with pre-determined heart conditions, are at a significantly higher risk for heart problems after using testosterone replacement therapies. Within the first three months of treatment, this demographic of men had twice the rate of heart attacks as during the full previous year, before beginning treatment. Researchers compared this group to an unrelated group of men taking Viagra and Cialis for erectile dysfunction. They found that, unlike the Low T group, the latter group did not experience any new heart issues after taking Viagra or Cialis.
  • The Journal of the American Medical Association conducted a separate study of older men on testosterone therapy. Approximately 29% of the group suffered a stroke, heart attack, or death while undergoing therapy.
  • In 2009, federally-funded researchers were in the process of examining the effects of testosterone gels on muscle mass. The study was cancelled after cardiac problems began to develop in some participants.

Federal Drug Administration (FDA) Requires Label Updates

In March 2015, the FDA raised labeling requirements, stipulating that all testosterone replacement therapies must have updated warning labels explaining the risks of heart attack and stroke. After reviewing multiple studies, the agency released a statement warning physicians of the dangers of over-prescribing Low T treatments, which are currently only approved to treat patients with hypogonadism. This condition is diagnosed through blood tests, which many doctors neglect to run. In response to the safety concerns surrounding Low T therapy, the New York Times reported that only one in four men using the therapy had ever actually received a blood test.

Altman & Altman, LLP – Serving Boston, Quincy, Cambridge, and Salem

Defective drugs are an especially dangerous category of product liability. Their effect on the body’s systems can result in permanent health conditions and even death. To boost profits, pharmaceutical companies are not always forthright about potential reactions and side effects of certain drugs. In product liability law, this is considered “failure to warn” and may be cause for investigation. If you feel you have been injured by a defective drug, Altman & Altman, LLP can help. Negligent drug companies should be held accountable for their actions. Our attorneys are dedicated to helping you obtain the compensation you deserve. Contact us today for a free consultation about your case.

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