Endo Launches Hormone-Raising Drug in Weeks that Follow Testosterone Lawsuit Filings
An Irish drug company is rolling out a new male hormone injection designed similarly to medications that have been tied to heart attacks in numerous testosterone lawsuit allegations.
CBSNews.com reported on March 7th that the long-acting therapy, Aveed, has been approved by the U.S. Food and Drug Administration (FDA) for men with low levels of the hormone. Produced by Endo Pharmaceuticals, the prescription treatment therapy is expected to launch this month amid scrutiny surrounding several others on the market are currently being investigated by regulators.
Men File Testim, AndroGel Lawsuit Claims Following FDA Safety Alert
On January 31, the FDA announced its safety review of products similar to Aveed after a 45,000-patient study found a doubled risk of heart attack in men over 65 who took certain testosterone therapies. In the weeks that followed, court documents show four AndroGel lawsuits filed in the U.S. District Court, Northern District of Illinois on behalf of men who may have experienced serious cardiovascular events, and a complaint filed on February 26th against the makers of Testim. This testosterone lawsuit was filed in the U.S. District Court for the Central District of California by a man who allegedly experienced a stroke after taking the prescription medication to treat such symptoms as fatigue, weight gain and low libido, among other symptoms of aging.
According to CBS, the consumer advocacy group Public Citizen, has openly opposed the FDA’s approval of Aveed, and has asked regulators to reverse its decision. A letter sent by the founder of its Health Research Group points to a 9-9 vote last year by an FDA panel of outside advisors, who issued a split opinion on whether Aveed is safe to treat men with low testosterone.
“It is likely, if not certain, that the vote against safety would have been even greater had there been a presentation and discussion of the cardiovascular risks known at that time,” the letter states.
As Endo prepares to launch Aveed, the company is facing mounting litigation over some of its other products. Approximately 16,000 cases have now been filed by transvaginal mesh lawsuit claimants who allege serious and debilitating injuries caused by pelvic inserts produced by its subsidiary, American Medical Systems.
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