On September 17, 2014, the FDA overwhelmingly voted to restrict the use of testosterone medications. During the meeting discussing testosterone's future, Dr. John Teerlink stated, "There's no way testosterone would be approved for the treatment of age-related low-T today, by contemporary regulatory standards. We have no evidence of any benefit for patients and we have questions about clinical safety." Dr. Teerlink was not alone.
The FDA panel voted 20 - 1 in favor of restricting testosterone prescription and use. The prescribing language on blockbuster testosterone medications, like AndroGel, will be revised to clarify that testosterone has not been shown to reverse common aging issues like low libido, fatigue and muscle loss. This labeling change will drastically limit testosterone's approved indication and exclude millions of American men currently taking testosterone medications.
The FDA panel also voted to conduct additional long-term studies to evaluate the long-term safety risks of testosterone use in any population. Multiple studies have shown that testosterone use is linked to an increased risk of heart attacks, strokes, congestive heart failure, pulmonary embolism and blood clots.
If you or a loved one suffered a heart attack, stroke, pulmonary embolism, blood clot or congestive heart failure, please call our experienced AndroGel attorneys at (888) 606-5297 for a free consultation about your potential AndroGel lawsuit.