According to Fox News, U.S. health regulators have recently scheduled an advisory committee meeting for September 2014 to discuss the testosterone heart attack risk that may be associated with certain testosterone replacement therapies for men. Attendees will include the U.S. Food and Drug Administration’s (FDA) drug safety and risk management advisory committee and the bone, reproductive, and urologic advisory committee.
The meeting, organized by the FDA, will be held on September 17, and experts will discuss a category of low testosterone products designed to raise low testosterone levels in men. The FDA issued a warning in January 2014 regarding the potential testosterone heart attack risk as well as the possibility for men to suffer from strokes, blood clots, and other cardiovascular complications.
In the January 31 alert, the agency warned that no confirmed relationship had been established between the risk for injury and testosterone treatments, but that multiple studies suggested a link between the two in older men and in younger patients with a pre-existing risk for cardiovascular disease.
FDA to Discuss Testosterone Heart Attack Risk
The latest FDA action follows increasing concerns over the prescription of these testosterone treatment therapies as well as the formation of a multidistrict litigation at the federal level involving well-known products such as AndroGel and other similar treatments. As of July 15, 156 lawsuits have been filed in the U.S. District Court, Northern District of Illinois, according to a Case List update.
Plaintiffs claim that they were not adequately warned regarding the testosterone heart attack risk and other potential complications prior to beginning the treatments. Additionally, court documents indicate that the manufacturers are accused of promoting “Low T” therapies for uses not tested nor approved by the FDA, including fatigue, low libido and other natural conditions associated with aging.
AndroGel and other similar testosterone treatment therapies are only FDA-approved to treat abnormally low levels of testosterone, or hypogonadism, which have developed as a result of a pre-existing medical condition. In June 2014, the FDA ordered all manufacturers of testosterone replacement therapies to update their products’ warning labels to include a warning pertaining to the risk of blood clots in the veins as well as the potential testosterone heart attack risk.
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If you or someone you love was adversely affected by a testosterone replacement therapy and you wish to learn more about your options, contact Attorney Group. There is no cost to speak with us, and we can help you determine if you are eligible to seek damages for your injuries. We can connect you with an affiliated attorney who can assist you in pursuing your claim and recovering appropriate compensation to which you may be entitled.