Testosterone therapy risks assessed by FDA

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An FDA advisory committee assessed testosterone therapy cardiovascular risks at a recent wo-day meeting.

The purpose of the meeting was to obtain recommendations from a panel of independent experts in an effort to improve the safety of testosterone replacement therapy.  In numerous studies, testosterone replacement therapy has been linked to an increased risk of cardiovascular injury including heart attacks, strokes and blood clots.

The advisory committee experts were strongly in favor of revising the prescribing language on testosterone replacement products.  The panel stated that testosterone products should clearly set forth that these products are not effective in reversing normal symptoms of aging – fatigue, muscle loss and low libido.  The experts voted overwhelmingly that the indications for prescribing testosterone replacement products should be limited to men who have an inability to produce normal levels of testosterone due to an actual medical disorder.  In addition, the committee believed that pharmaceutical companies that produce the replacement therapy products be required to conduct a long-term study on how the products affect the cardiovascular system.

Testosterone replacement products have been aggressively advertised to consumers, becoming a multi-billion dollar industry.  Some of the advertising campaigns claims that the products can counteract common symtoms of the normal aging process in addition to treating low testosterone – “Low T.” 

Hundreds of lawsuits have already been filed, alleging the products to be dangerous and alleging heart attacks, strokes, blood clots and death in men who used the products.  Popular testosterone products include AndroGel, Axiron, Testim and Androderm.

The Ohio Testosterone Injury attorneys at Clark, Perdue & List are experienced in handling pharmaceutical injury claims.  Clark, Perdue & List have represented hundreds of individuals who have been injured or killed by dangerous drugs and defective medical devices.  If you or a loved one has suffered a cardiovascular injury that you believe was caused by use of a testosterone replacement product, call Clark, Perdue & List.