Amid the filing of testosterone replacement therapy lawsuits, the U.S. Food and Drug Administration has called a Sept. 17 meeting of two expert committees to examine who should be permitted to receive the treatment and the extent to which such therapy poses cardiovascular risks.
The agency will bring together one committee with urologic expertise and another whose purview is drug safety and risk management. On the table will be a pair of studies that got the FDA’s and the pharmaceutical industry’s attention. Both site a serious risk of major adverse cardiovascular events, known as MACE, associated with testosterone replacement therapy.
Without a doubt, testosterone replacement therapy, or TRT, is becoming more widespread.
“FDA’s analysis of drug utilization data for TRT over the past 5 years shows a significant increase in the use of testosterone therapy,” according to an FDA briefing paper to be submitted to the joint committee meeting. “From 2009 to 2013, sales of TRT in terms of kilograms of active ingredient saw an increase of 65 percent, with approximately 8,500 kilograms sold in 2009 to 14,000 kilograms sold in 2013. In 2010, 1.3 million patients received a prescription for testosterone and by 2013, this number has risen to 2.3 million patients.”
Here is another growing figure worthy of note. Among the testosterone replacement therapy lawsuits filed across the nation in state courts, nearly 200 federal lawsuits have been centralized before the U.S. District Court for the Northern District of Illinois, where one judge presides over the consolidated pretrial management.
“All actions involve plaintiffs (or their survivors) who used one or more testosterone replacement therapies and contend that their (or their decedent’s) use of the drugs caused their injuries, which include heart attack, stroke, deep vein thrombosis, and pulmonary embolism,” according to the U.S. Judicial Panel on Multidistrict Litigation.
Men who received testosterone replacement therapy and who since the onset of therapy experienced heart attack, stroke or severe blood clotting injury may be entitled to compensation. The Testosterone Replacement Therapy Litigation Team at Reich & Binstock is offering a free consultation to the injured parties as it investigates whether there are grounds for the filing of a testosterone replacement therapy lawsuit.
For 30 years, the skilled product liability attorneys at Reich & Binstock have been holding pharmaceutical companies accountable for the unreasonable risks posed by their drugs or medical devices and for the unfortunate injuries resulting from their use. Reich & Binstock is well-resourced and highly skilled in this area of litigation and wants to help. It costs nothing to find out whether there is a case. All one must do, no matter the state of residency, is contact Reich & Binstock for a free consultation.
Reach Reich & Binstock either at 713-622-7271 or by sending an electronic message through the law firm’s website.