FDA Schedules Testosterone Advisory Meeting for September to Discuss Heart Risks
U.S. health regulators have scheduled an advisory committee meeting in September to discuss serious cardiovascular side effects that may be associated with certain testosterone treatments for men, according to FoxNews.com.
The meeting was organized by the U.S. Food and Drug Administration (FDA) and will take place on September 17th, according to recent reports, where experts will discuss a class of “Low T” testosterone medications designed to raise abnormally-low hormone levels in men.
In January, the FDA issued a federal warning about the alleged risk for AndroGel, Testim, AndroDerm and other medications to cause strokes, heart attacks, blood clots and other heart injuries that may be life-threatening. The agency warned in its January 31st alert that no confirmed connection had been made between testosterone treatments and the risk for injury, but that multiple studies had suggested an association between the two in younger patients with a pre-existing risk for heart disease, and all older men.
According to a report on July 18, the FDA’s bone, reproductive and urologic advisory committee and the drug safety and risk management advisory committee will come together at the September meeting.
FDA Meeting Follows Testosterone MDL, Federal Warning about Heart Risks
The agency’s latest action follows mounting concerns over prescription testosterone therapies, and the formation of a federal multidistrict litigation (MDL) involving AndroGel and other drugs. A Case List updated on July 15th indicates that 156 cases have been filed in the newly-established proceeding, which is now underway in the U.S. District Court, Northern District of Illinois. Plaintiffs in these claims, many of which including AndroGel lawsuit allegations, allege that men and their doctors were inadequately warned by testosterone manufacturers about their products’ risk for serious heart problems. These companies have also been accused of promoting “Low T” drugs for uses not specifically approved by the FDA, including the treatment of low libido, fatigue and other symptoms of aging, according to court documents.
AndroGel and other drugs are currently only cleared to treat abnormally low levels of testosterone, a condition known as hypogonadism, in conjunction with another medical condition.
In June, the FDA ordered that all testosterone therapies on the market update their warning labels to include a general warning about blood clots in the veins.
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