FDA Requires Testosterone Manufacturers to Revise Heart Attack Warning on Drug Labels
The U.S. Food and Drug Administration (FDA) is ordering a number of manufacturers, many of which are currently preparing to defend testosterone lawsuits, to revise their product labeling to fully note a possible association with life-threatening heart problems.
The federal agency alerted the public of its new guidelines in a Safety Announcement published on March 3rd, 2015, which follows several actions related to the hormone drugs. In September 2014, a panel of advisers convened by the FDA met to discuss issues related to prescription testosterone treatments and voted 20-1 to adjust the labeling so that men are adequately notified about their lack of proven effectiveness for AndroGel, Testim, Axiron and other medications to treat certain aging issues. Panelists also recommended that manufacturers of products on the market be required to conduct clinical trials that assess their potential to cause cardiovascular problems, and submit results to the FDA.
Use of Testosterone Treatments Grew 75% over Four Years
The federal agency’s announcement about its new guidelines also includes a recent statistic that shows a sharp increase in the number of U.S. men taking them between the ages of 40 and 64. According to the FDA, 75 percent more people were taking AndroGel, Testim or another testosterone treatment in 2013 than the amount that did four years earlier, which has reaped financial benefits for their manufacturers. According to a report from CNBC.com, sales of the medication, sales of AndroGel earned $934 million in 2014 for AbbVie Inc., while Endo International’s Testim and the medication, Axiron following closely behind.
The U.S. Food and Drug Administration (FDA) first warned about the dangers of testosterone treatment therapies on January 31, 2014. Among other things, the public was alerted at this time that two studies had found an increased heart attack risk in men older than 65, and all younger men with a pre-existing history of heart disease.
This and other complications have been alleged in more than 1,000 testosterone lawsuits now pending in the U.S. District Court, Northern District of Illinois. There, a federal multidistrict litigation (MDL) has been established for claims that accuse the manufacturers of several medications of failing to properly warn about cardiovascular side effects that may stem from use of its products.
Call a Testosterone Lawyer
Contact a testosterone lawyer at Bernstein Liebhard LLP to learn more about the process of filing a lawsuit against the makers of AndroGel, AbbVie or another product. Call us now at (877) 779-1414.