FDA May Tighten Restrictions for Testosterone Drugs
CBS reports that the FDA Advisory Committee voted 20-1 that the product labels of popular testosterone drugs should be revised to clearly indicate that these drugs have not been shown to reverse common aging issues, including muscle loss and libido. Members of the Advisory Committee also unanimously agreed that evidence linking cardiovascular events and blood clots to testosterone drugs is “inconclusive” and drug manufacturers should be required to conduct long-term studies examining the cardiovascular effects.
The FDA called for the Advisory Committee, a committee of outside experts, to review the risks and benefits of testosterone drugs in light of recent studies suggesting an increased risk of cardiovascular effects and problems for men. Narrowing the use of these drugs would affect the population of men taking these testosterone drugs with low hormone levels due to aging, rather than those with low hormone levels due to injury or disease. Experts acknowledge that it will be difficult to change the prescribing habits of physicians in this regard. Marjorie Shaw Phillips, member of the FDA Advisory Committee and physician at Georgia Regents Medical Center, said, “I think the current labeling is vague and has been subject to misinterpretation.”
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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