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2,000 Testosterone Lawsuits Filed, But Study Questions Risks

July 20, 2015 — Mayo Clinic Proceedings has published a study that found no link between the use of testosterone and venous thromboembolism (VTE).

The label on testosterone has carried warnings about VTE as a possible complication of polycythemia, an abnormal increase in the number of red blood cells that sometimes occurs with testosterone treatment.

Last year, the FDA ordered drug-makers to add a general warning about VTE. In March, the FDA ordered drug-makers to add warnings about the possible risk of heart attack and stroke.

Drug-makers are now facing about 2,000 lawsuits from people who had a blood clot, heart attack, stroke, or other serious injury after using testosterone, according to statistics (PDF) issued by the U.S. Judicial Panel on Multidistrict Litigation (JPML). The lawsuits have been centralized in a Multi-District Litigation (MDL No. 2545) in one federal court in Illinois since last year, where they are overseen by Judge Matthew F. Kennelly.

All of the lawsuits accuse drug-makers of failing to warn about side effects while aggressively marketing testosterone for “Low T,” a vague collection of symptoms that occur as a natural part of aging — not hypogonadism, the only condition testosterone is approved to treat.

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