Men who use Fortesta to treat low testosterone may face a significantly increased risk of heart attack and stroke, especially if they are over the age of 65. Thousands of plaintiffs are now pursing testosterone lawsuits for cardiovascular injuries they allegedly suffered due to their use of low-T therapies like Fortesta.

Are You Eligible to File a Fortesta Lawsuit?

You may be eligible to file a Fortesta lawsuit if you or a man you love experienced any of the following complications while using this testosterone treatment:

  • Heart Attack
  • Stroke
  • Blood Clots
  • Pulmonary Embolism
  • Deep Vein Thrombosis
  • Cardiac Death

If you would like to explore your legal options, please contact Bernstein Liebhard LLP at (888) 994-5118.

Fortesta: What’s the Problem?

Fortesta is a topical gel marketed by Endo Pharmaceuticals that is applied to the skin on the thighs once every morning. Like other prescription testosterone treatments, Fortesta is only indicated to treat hypogonadism (low testosterone) that is related to an underlying medical condition, such as a problem with the pituitary gland or side effects of chemotherapy. The safety and efficacy of Fortesta in men with “age-related hypogonadism” (also referred to as “late-onset hypogonadism”) have not been established.

The U.S. Food & Drug Administration issued a Safety Communication in January 2014 announcing that it was reviewing Fortesta and other low-T treatments after two studies linked the drugs to an increased risk of heart attacks:

  • November 2013: A JAMA study finds that use of testosterone replacement therapy is associated with a 25.7% risk of cardiovascular side effects, compared to 19.9% for men who were not on the drugs.
  • January 2014: Research published in PLoS One that involved 55,000 men linked low-T drugs to a two-fold increased risk of heart attacks in those over 65. Younger men with pre-existing heart disease were three times as likely to have a heart attack if they used testosterone.

In March 2015, the FDA ordered low-T manufacturers to add new warnings to their drug labels regarding a possible association with heart attacks and strokes.

Testosterone Blood Clot Alert

In June 2014, new blood clot warnings were added to the labels of all prescription testosterone treatments, after the FDA determined that the drugs may increase the risk for venous blood clots such as pulmonary embolism and deep vein thrombosis. Read More

Testosterone Lawsuit Developments

  • May 2014: A Fortesta lawsuit filed on behalf of a Georgia man claims that the drug’s manufacturers failed to provide adequate warnings regarding the increased risk of heart attacks and other cardiovascular injuries associated with the use of the low testosterone therapy. The complaint also questions the marketing tactics used to drive sales of Fortesta. Read More
  • June 2014: A multidistrict litigation has been created for all federally-filed testosterone lawsuits brought on behalf of men who allegedly suffered heart attacks, strokes and blood clots due to their use of low-T therapies. The new litigation will be housed in the U.S. District Court, Northern District of Illinois, where the cases will undergo coordinated discovery and other pretrial proceedings. Read More

Are You Eligible to File a Fortesta Lawsuit?

You may be eligible to file a Fortesta lawsuit if you suffered a heart attack, stroke or dangerous blood clot while using this low-T treatment. To learn more about the growing testosterone litigation, please call (888) 994-5118.

  1. FDA (2014) “FDA Drug Safety Communication: FDA evaluating risk of stroke, heart attack and death with FDA-approved testosterone products”
  2. JAMA (2013) “Association of Testosterone Therapy With Mortality, Myocardial Infarction, and Stroke in Men With Low Testosterone Levels”
  3. PLoS One (2014) “Increased Risk of Non-Fatal Myocardial Infarction Following Testosterone Therapy Prescription in Men”
  4. FDA (2014) “FDA adding general warning to testosterone products about potential for venous blood clots”
  5. FDA (2015) “FDA Drug Safety Communication: FDA cautions about using testosterone products for low testosterone due to aging; requires labeling change to inform of possible increased risk of heart attack and stroke with use”
Last Modified: February 23, 2016

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