EMA Agrees with FDA: Testosterone Therapy Drugs Not for Lifestyle Use
According to a recent report, the EMA has agreed with the FDA that the use of testosterone drugs should be reserved for men whose testosterone levels are low due to a medical condition. An EMA oversight committee said, “Testosterone levels naturally fall somewhat with age, but restoration of these levels in healthy older mean is not an authorized use of the medicine in the EU.” This is similar to the conclusion reached in September by an FDA Advisory Committee who voted 14-1 to restrict use of testosterone replacement therapies to men who have a related medical condition.
On January 31, 2014, the FDA issued a Safety Announcement that it is investigating a potential link between testosterone use and stroke, myocardial infarction (MI), and death, as demonstrated by published studies. The first study that prompted the FDA’s Safety Announcement was published in the Journal of the American Medical Association (JAMA) in November 2013 and suggested that testosterone replacement drugs may increase the risk of heart attack, stroke and death. The second study, published in the online journal PLos ONE on January 29, 2014, concluded that older men, and younger men with pre-existing diagnosed heart disease, have an increased risk of heart attack following initiation of testosterone therapy. Bloomberg further reports that 2.3 million men currently take testosterone products, which is a 43% increase from 2010.
According to the most recent report from the Judicial Panel on Multidistrict Litigation, there are over 250 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 MDL. 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 in the MDL 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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