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Testosterone Lawsuit Update: FDA Advisory Committee Decides Further Study of Cardiovascular Risks Required

defective-drugs-imgBloomberg News reports that the members of a Food and Drug Administration (FDA) Advisory Committee unanimously agreed this week that manufacturers of testosterone drugs should further study the potential cardiovascular health risks of testosterone products and who should take these drugs.

According to the FDA, the 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.”

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 200 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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