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The Food and Drug Administration (FDA) announced on January 31, 2014 that it is investigating the health risks of testosterone therapy products after recent studies showed an increased risk of cardiovascular events, including heart attack, stroke, blood clots and death, among groups of men prescribed testosterone therapy.
Testosterone is a hormone essential to the development of male growth and masculine characteristics. It has a role in sex drive, and it helps men maintain muscle mass, red blood cell production, fat distribution and bone density. The FDA has clarified that these products are approved only for use in men who lack or have low testosterone levels in conjunction with an associated medical condition. Such conditions include, but are not limited to:
- The failure of the testicles to produce testosterone because of reasons such as genetic problems;
- Chemotherapy; and
- Problems with brain structures (called hypothalamus and pituitary) that control the production of testosterone by the testicles.
None of the FDA-approved testosterone products are approved for use in men with low testosterone levels who lack an associated medical condition.
Testosterone therapy can come in the form of topical gels, transdermal patches, buccal systems (applied to the upper gum or inner cheek), and injections. The attorneys at Ashcraft & Gerel, LLP are investigating potential lawsuits against the makers of these drug therapies on behalf of men who have experienced cardiovascular injuries after using a testosterone therapy product.
Scientific studies show that medical complications that can arise from using testosterone therapy include the following:
- Heart attacks
- Blood clots
These studies also prove that dangerous blood clots can develop as soon as one month after testosterone replacement therapy begins. In addition, the studies have shown that many men who have experienced blood clots after starting testosterone therapy had unknown, inherited clotting disorders that put them at greater risk for developing clots. However, they were not tested for these clotting disorders by their physicians prior to starting the drug therapy.
News media covering the large increase in prescription testosterone product sales report that pharmaceutical advertising of testosterone products promotes excessive and inappropriate use of the drug. In 2013, the New York Times reported that many physicians believe that the testosterone products may have questionable medical benefits for the millions of men who now take them while the side effects remain very dangerous. When asked about these prevalent testosterone therapy drugs, Dr. Eric Topol, cardiologist and chief academic officer at Scripps Health in San Diego, got straight to the point, stating, “These medicines come with a risk of coronary artery disease.” Despite its questionable medical value, the industry made over $2 billion on testosterone therapy gels in 2012 alone due to its marketing of testosterone products as “lifestyle products.”
Contact Us Today
Ashcraft & Gerel, LLP is investigating possible lawsuits against the makers of testosterone products. If you feel that you or someone you know should be compensated for harm caused by a testosterone therapy product or products, please contact us online or call us at 800-829-7037 to speak with an attorney today. All consultations are free and completely confidential.