March 5, 2014 — Auxilium Pharmaceuticals is facing a lawsuit from a man who used Testim (1% testosterone gel) and had a stroke. The lawsuit (.PDF) was flied February 26 in the U.S. District Court for the Central District of California.
The 56 year-old plaintiff, Joseph Myers, started using Testim to treat symptoms he attributed to “low testosterone” after viewing advertisements. In February 2012, he suffered a stroke.
A few days later, doctors said they believed his stroke was caused by Testim. As a result of the stroke, Myers had memory loss and must use oxygen therapy 24 hours a day. Before this stroke, he had no history of cardiovascular problems and was not aware of the link between Testim and stroke.
According to the complaint:
Defendant engaged in an aggressive unbranded “disease awareness” campaign to alert men that they might be suffering from “Low T.” As a result, diagnoses of Low T have increase exponentially. This has directly related to Testim’s sales increasing to over $209 million per year. However, consumers of Testim were misled as to the drug’s safety and efficacy, and as a result have suffered injuries including life-threatening cardiac events, strokes and thrombolytic events.”
The lawsuit cites a number of studies linking Testim and stroke. Testosterone is a controlled substance because it is often used by athletes to “pump up” their blood — thickening blood and increasing the number of red blood cells. Not surprisingly, this can substantially increase the risk of blood clots, especially in older men.
In November 2013, a JAMA published a study titled “Association of Testosterone Therapy with Mortality, Myocardial Infarction, and Stroke in Men with Low Testosterone Levels” linking testosterone to a 30% increased risk of heart attack, stroke, and death.
In January 2014, PLOS ONE published a study titled “Increased Risk of Non-Fatal Myocardial Infarction Following Testosterone Therapy Prescription in Men” linking the use of testosterone to a doubled risk of heart attacks in men over 65 years old.
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