FDA Enforces Warning Labels on Testosterone Therapy

FDA Requires Warnings on Testosterone Therapy About Blood Clots

warning labels on testosterone therapyOn Thursday, June 19th, the Food and Drug Administration (FDA) announced that it would require warning labels on testosterone therapy, including AndroGel, that would inform consumers about the risks of blood clots and strokes.

Postmarket studies of blood clot and stroke risks related to testosterone therapy prompted the FDA to make warning label changes on the products.

Warning labels on testosterone therapy products already mention the possibility of polycythemia, a condition in which testosterone therapy can increase the amount of blood cells in the patient. Previously, testosterone therapy manufacturers argued that polycythemia was related to blood clots, but the FDA announced this week that the risk of blood clots due to testosterone therapy use was not related to polycythemia.

The agency will require the warning label to be more general, the FDA said.

“Because there have been postmarket reports of venous blood clots unrelated to polycythemia, FDA is requiring a change to drug labeling of all testosterone products to provide a more general warning regarding venous blood clots and to ensure this risk is described consistently in the labeling of all approved testosterone products,” the FDA press release stated.

The warning label change comes after two judges in Chicago agreed to consolidate lawsuits involving two testosterone therapy manufacturers, Eli Lilly and Abbott/AbbVie.

“Abbott separated its research-based pharmaceutical business into a new public biopharmaceutical company called AbbVie in January 2013,” Scott Stoffel, an Abbott spokesman, said in an e-mailed statement. “With the separation, the U.S. commercial rights and associated responsibilities for AndroGel passed to AbbVie.”

The AndroGel lawsuits were filed on behalf of Michael Gallagher, of Midlothian Virginia; Steven Myers, of Fort Worth, Texas; Steve Marino, of Saint Louis, Missouri; and Kenneth Aurecchia, of Johnston, Rhode Island. The men range from 50 to 63, and deny any previous history of cardiac problems. Gallagher, Myers, and Aurecchia said they suffered heart attacks, and Marino suffered a stroke. A fifth unnamed plaintiff suffered a mini-stroke.

Currently, there are about 45 testosterone therapy lawsuits in the multidistrict litigation (MDL); Kennelly will likely see thousands more as more men come forward regarding their problems.

A JAMA study, published earlier in January, showed that the 14% of men taking testosterone therapy supplements after undergoing angiography generally appeared slightly healthier and younger than the 86% of men involved in the study who did not receive testosterone therapy. While this can support short-term benefits for the drugs, when the men were followed for three years, those who took testosterone supplements were 30% more likely to have an ischemic stroke, heart attack, or die of other causes, than the control group. In that three year period, 25.7% of men taking the supplement had a heart attack or stroke; in the control group not taking testosterone therapy drugs, only 19.9% suffered these outcomes.

The Strom Law Firm Can Help with Dangerous Drug Cases, Including Testosterone Therapy and Supplements like AndroGel

The Strom Law Firm, L.L.C. is a leader in the consumer protection battle against dangerous prescription drugs and medical devices, from AndroGel to Zoloft. We represent individuals who have been killed or injured by dangerous or defective pharmaceuticalsIf you or a family member have been injured or killed after using a dangerous drugs or medical products such as testosterone therapy or supplements, contact our dangerous drug lawyers as soon as possible so that we can begin taking steps to preserve evidence and your claim immediately. We offer free consultations to discuss the facts of your case. 803.252.4800



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