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FDA Requires New Labeling Change for Testosterone Drugs Regarding Increased Risk of Heart Attack and Stroke

defective-drugs-imgOn March 3, 2015, the Food and Drug Administration (FDA) issued a Safety Announcement cautioning that testosterone products are approved only for men who have low testosterone levels caused by certain medical conditions, rather than due to aging. The FDA also required manufacturers of testosterone drugs to clarify the approved uses of these medications and add information to their product labels regarding a possible increased risk of heart attacks and strokes for patients taking these testosterone boosting drugs. This Safety Announcement is an update to the FDA’s previous Safety Announcement issued on January 31, 2014 where the FDA announced that it was investigating a potential link between testosterone use and stroke, heart attack and death.

The FDA now cautions as follows: “The benefit and safety of these medications have not been established for the treatment of low testosterone levels due to aging, even if a man’s symptoms seem related to low testosterone. We are requiring that the manufacturers of all approved prescription testosterone products change their labeling to clarify the approved uses of these medications. We are also requiring these manufacturers to add information to the labeling about a possible increased risk of heart attacks and strokes in patients taking testosterone. Health care professionals should prescribe testosterone therapy only for men with low testosterone levels caused by certain medical conditions and confirmed by laboratory tests.”

An Advisory Committee Meeting was held on September 17, 2014 for the purpose of discussing the appropriate indicated population for testosterone replacement therapy and the potential for adverse cardiovascular outcomes associated with this use. The members of the Advisory Committee unanimously agreed that manufacturers of testosterone drugs should further study the potential cardiovascular health risks of testosterone products and who should take these drugs. Based on the available evidence from published studies and input from experts during the Advisory Committee Meeting, the FDA concluded that there is a possible increased cardiovascular risk associated with testosterone use. The FDA is not only requiring labeling changes to reflect the possible increased risk of heart attacks and strokes, but is also requiring manufacturers of these testosterone boosting drugs to conduct a well-designed clinical trial investigating whether an increased risk of heart attack or stroke exists among users of these products.

According to the most recent report from the Judicial Panel on Multidistrict Litigation (JPML), there are over 1,000 testosterone lawsuits currently pending against the drug manufacturers in the United States District Court for the Northern District of Illinois before The Honorable Judge Matthew F. Kennelly (In re: Testosterone Replacement Therapy Products Liability Litigation, MDL 2545). Schlichter, Bogard & Denton are leaders in the national Low-T Multidistrict Litigation. In early July, Judge Kennelly appointed Kristine Kraft of Schlichter, Bogard & Denton to the Plaintiffs’ Steering Committee, which will oversee and manage the growing number of cases pending against the Low-T manufacturers. If you or a loved one has suffered injuries after using testosterone products, please contact the attorneys at Schlichter, Bogard & Denton, LLP toll-free at 1-800-873-5297 for your confidential and free consultation.


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