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Articles Posted in Low T/Testosterone Replacement Therapy

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As previously reported in this blog, the U.S. Food and Drug Administration (FDA) announced in January, 2014, that it was launching an investigation into whether FDA-approved testosterone products are causing strokes, heart attacks and even death. Several studies have shown that use of testosterone replacement therapies, such as AndroGel and Axiron, for the dubious medical condition “Low T” actually increases the risk of heart attacks and strokes in men using the product.

Although in its beginning stages, several lawsuits have been filed in the Federal District Court in Chicago, Ill., the district where Abbvie, the maker of AndroGel, is headquartered. The U.S. Judicial Panel on Multidistrict Litigation has now ruled that these cases, and cases that will follow, will be consolidated into a MDL, much as transvaginal mesh and Stryker hip cases were. The new MDL will be styled ‘In re: Testosterone Replacement Therapy Products Liability Litigation’ and will include not just cases brought against Abbvie, but those brought against several other manufacturers. We will continue to monitor these developments and will investigate claims involving these testosterone therapies and “Low T”.
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A recent issue of The Journal of the American Medical Association (JAMA) details a clinical trial relating to the risk of heart attack (myocardial infarctions) in men treated with testosterone therapies such as the popular products AndroGel and Axiron. Pharmaceutical companies are marketing these drugs to men for a condition described as “Low T” or low testosterone levels. There is, however, no distinct medical condition known as “Low T”, lowering testosterone levels are part of the normal aging process in men and the FDA has not approved the use of these drugs for men who simply have low testosterone levels without any related medical condition. Prescriptions for testosterone therapies in the U.S. have increased dramatically in the last decade and now account for approximately $2 billion in annual sales.

The JAMA update details the results of a clinical trial published in PloS One in January, 2014. That clinical trial found that men aged 65 and older experienced a two-fold increase in the risk of heart attack in the first 90 days of starting testosterone therapy. The trial also found that men under the age of 65 with a history of heart disease experienced a two to three-fold increased risk of developing a heart attack. The authors stated their concern over the increasing use of testosterone therapies in the absence of clinical trials showing any purported benefit of the treatment. They also warned physicians to counsel patients regarding the potential risks of a heart attack, specifically in men with pre-existing cardiovascular disease. This article joins the growing body of scientific literature, including two articles in the New England Journal of Medicine, drawing attention to the serious risks involved in the use of testosterone therapy and questioning drug manufacturers’ claims regarding the benefits of the treatment. The pharmaceutical industry and doctors working as paid consultants for the industry have gone on the offensive with attempts to discredit this peer-reviewed research. This is not at all surprising when one considers the astonishing amount of sales generated by these testosterone replacement therapies.

Any patient contemplating testosterone or low-T therapy would be wise to read these recent studies and discuss the associated risk factors with his doctor.

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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”.