The risk for potential cardiovascular events - that could lead, in serious cases, to testosterone death - was exactly the point made by the FDA when it released its statement of caution last month, along with taking the position that labels on products within the “Low-T” sector should carry updated warnings over the possibility of testosterone heart attack, along with other side effects and adverse events.
In its statement, issued March 3 of this year, the FDA noted that prescription testosterone supplementation is only approved for men with low testosterone levels according to a proper diagnosis in association with certain medical conditions. While testosterone can and does fluctuate and diminish with age (a normal process of aging), serious depletion of testosterone approaching dangerously low levels can foster equally serious health issues, for which treatment with testosterone supplements is both warranted and medically necessary.
The problem appears to be the birth and massive growth of a pro-testosterone industry that appears to advocate testosterone supplements as an answer to low energy levels and flagging libido due, as it is oft suspected, to depletion of testosterone. Thus, “Low-T” has become something akin to a fountain of youth for men persuaded to employ testosterone therapy as a means to return to their younger selves, rather than in response to a diagnosed medical condition.
However, testosterone therapy has its risks. Such risks are thought to be mitigated by the benefits of supplementation for serious testosterone depletion that carries its own potentially serious health risks. In the absence of serious testosterone depletion, the benefits of testosterone supplementation continues to be hotly debated - and litigated - given the assertion and suspicion that testosterone side effects, in such a context, are wholly unnecessary.
That’s the point the FDA is trying to make: “Based on the available evidence from published studies and expert input from an Advisory Committee meeting, FDA has concluded that there is a possible increased cardiovascular risk associated with testosterone use,” the statement said. “These studies included aging men treated with testosterone. Some studies reported an increased risk of heart attack, stroke, or death associated with testosterone treatment, while others did not.”
Plaintiff Lee Cohen knows this all too well. According to his testosterone lawsuit, the 62-year-old Maryland resident was using Testim for testosterone supplementation when he suffered an ischemic stroke in early April 2013 followed by a heart attack about three months later. Cohen was 62 when it happened. Cohen and his co-plaintiff, Kyoko Cohen, allege it was Lee’s use of Testim that caused his adverse health issues.
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The Cohen testosterone lawsuit is part of the multidistrict litigation docket for testosterone, Master Docket Case No. 1:14-cv-01748, consolidated before the Honorable Matthew F. Kennelly in US District Court, Northern District of Illinois, Eastern Division. It should be noted that the website for the Court, as of March 27, shows no fewer than 1,291 lawsuits pending In re: Testosterone Replacement Therapy Product Liability Litigation - MDL No. 2545.
The Cohen testosterone lawsuit is Lee Cohen and Kyoko Cohen v. Auxilium Pharmaceuticals Inc., Case No. 1:15-cv-00494, filed January 19, 2015, US District Court, Northern District of Illinois, Eastern Division.