FDA begins “Low T” Investigation

This past January, the U.S. Food and Drug Administration (FDA) announced that it will be researching whether FDA-approved testosterone products are causing severe medical problems including heart attacks, strokes and even death. These testosterone replacement therapy products— purportedly prescribed for low testosterone levels, also labeled "Low T"—are heavily marketed towards older men and have increasingly raised suspicion in the medical field. Recent research has questioned whether the product has any medical value for the majority of patients they are being prescribed to.

Testosterone replacement therapies (TRT) consist of a gel or underarm roll-on that deliver low doses of testosterone which are absorbed through the skin. Although testosterone replacement therapy products have been offered to the public for many years, the past decade has seen a drastic increase in TRT marketing by the drug manufacturers. They claim that TRT products boost energy levels, fight muscle mass loss, increase sex drive and accomplish much more for their older, male demographic. In reality, there is no distinct medical condition known as "Low T" and lowered testosterone levels are normal in aging men. Despite this, pharmaceutical companies are cashing in on “Low T” - 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 express uncertainty on whether testosterone replacement therapy actually produces any of its claimed benefits. Many experts believe the benefits are merely a "placebo effect". In addition, and more concerning, there is growing scientific evidence showing that the use of testosterone in some males causes their risk of heart attack or stroke to significantly increase. Thus far, manufacturers have not warned of these specific risks.  As further research is done, it may turn out that a majority of men being prescribed testosterone have only been putting themselves at risk of a serious and potentially deadly cardiovascular event. Many physicians also believe that manufacturers have aggressively and wrongly marketed the drug by claiming that lowered testosterone as one ages is harmful or caused by an underlying condition, rather than simply being part of the normal aging process. The FDA approved use for testosterone 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.