INSIGHTS On Massachusetts Personal Injury Law

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FDA Launches Investigation into Testosterone Replacement Therapies and Treatment of “Low T”

On January 31, 2014, the U.S. Food and Drug Administration (FDA) announced that it is launching an investigation into whether FDA-approved testosterone products are causing strokes, heart attacks and even death. These testosterone replacement therapy products, heavily marketed and prescribed to older men for a dubious medical condition labeled “Low T”, have become the subject of increased scrutiny in the medical field. New research calls into question whether the products have any medical value for the majority of patients they are being prescribed to and details how the use of these drugs can increase their risk of strokes and heart attacks for some men.

Testosterone replacement therapies (TRT) consist of a gel or underarm roll-on that deliver low doses of testosterone through the skin. Although testosterone replacement therapy products have been available to the public for many years, drug manufacturers have ramped up their marketing of TRT products in the past decade. Manufacturers claim, among other things, that TRT products boost energy levels, fight muscle mass loss and increase sex drive. These drugs are being marketed to men for a condition described by the pharmaceutical companies as “Low T” or low testosterone levels. In reality, there is no distinct medical condition known as “Low T” and lowering testosterone levels are part of the normal aging process in men. Despite this, “Low T” has become big business for pharmaceutical companies – in 2012, testosterone products accounted for $2 billion in sales in the U.S. The most commonly prescribed products are AndroGel (manufactured by AbbVie), Axiron (manufactured by Lilly and Acrux Ltd.) and Testim (manufactured by Auxilium and GSK).

Newly published scientific studies cast doubt on whether testosterone replacement therapy actually produces any of its claimed benefits. Many experts believe the claimed benefits are merely a “placebo effect”. In addition, and more concerning, there is a growing body of scientific studies showing that the use of testosterone in some males significantly increases their risk of heart attack or stroke. Manufacturers have not warned of these risks in their products’ literature. As further research is done, it may turn out that a vast majority of men being prescribed testosterone replacement therapies receive no medically significant benefit from it and needlessly have been put at risk of a serious and potentially deadly cardiovascular event. Many physicians also believe that manufacturers have excessively and inappropriately marketed the drug by claiming that lowered testosterone counts as one ages are detrimental or caused by an underlying condition, rather than simply being part of the normal aging process. The FDA approved use for TRT products stresses that they are only approved for men who have low testosterone “in conjunction with an associated medical condition”.

SUGARMAN is investigating claims where patients have suffered heart attacks, strokes or embolic events such as deep vein thrombosis or pulmonary emboli as a result of testosterone replacement therapies (TRT) such as AndroGel, Axiron and Androderm. Please continue to monitor our blog and our website for more information as developments arise. If you or a loved one has suffered a significant cardiovascular event while taking or soon after discontinuing testosterone replacement therapy, please fill out a Contact Form, call us at 617-542-1000 or e-mail info@sugarman.com.