Missy Clyne Diaz  |  December 24, 2014

Category: Legal News

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testosterone-therapy-300x242Worried about side effects such as heart attack and stroke deaths, the U.S. Food and Drug Administration (FDA) is looking into the marketing and safety of testosterone supplements prescribed to men to boost their sex drive, treat fatigue and depression as well as other lifestyle reasons, ABC affiliate WPDE reports.

The FDA is concerned that the drugs are “overprescribed and advertisers make the medications sound like they’re the fountain of youth.”

The side effects associated with the use of low testosterone therapy drugs have led to an influx of testosterone lawsuits.

What is Low-T Therapy?

Testosterone replacement therapy drugs are often prescribed for a condition commonly referred to as “low-t” or low testosterone.

Testosterone replacement therapy products are available in gels, patches applied to the skin or gums, pills and injections. More than 5.3 million prescriptions are written each year for testosterone replacement therapy drugs, known as “Low T” treatments.

Low-t drugs target men as young as their 30s who are purportedly suffering erectile dysfunction, depression, fatigue and diminished sex drive, a condition that occurs naturally as men age. Low testosterone is a condition that affects 5 million aging American men and is diagnosed when the hormone level in the blood drops below 300.

AndroGel received FDA approval in 2001; Testim the following year; and Axiron in 2010.

FDA Investigation

In addition to imposing strict limitations on how low-t drugs are prescribed, the FDA could also decide to limit how much insurance companies will cover when it comes to treatment for low testosterone, according to WPDE.

According to the FDA, testosterone is a hormone essential to the development of male growth and masculine characteristics. Testosterone replacement products are FDA-approved only for use in men who lack or have low testosterone levels in conjunction with an associated medical condition, such as failure of the testicles to produce testosterone due to genetic problems or chemotherapy.

Other examples include problems with the hypothalamus and pituitary, which 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.

In January, the FDA issued a safety announcement that the agency was investigating the increased risk of stroke, heart attack, stroke and death in men who took FDA-approved testosterone products.

The FDA cited two separate studies suggesting an increased risk of cardiovascular events among groups of men prescribed testosterone therapy.

A National Cancer Institute study of 56,000 patients found that men over 65, as well as men younger than 65 with a history of heart disease, had twice as many heart attacks in the three months after beginning testosterone therapy compared to the year before taking the drugs.

Low-T Drug Lawsuits

Due to a flood of lawsuits amid allegations of strokes, heart attacks and deaths during low-t therapy, a multidistrict litigation was established in June in the Northern District of Illinois for lawsuits involving Androgel, Testim and Axiron.

Cases against other pharmaceutical companies will be handled in the district in which the plaintiff resided at the time of original filing, until a later date, when the plaintiffs may challenge the jurisdiction.

Thousands of men who have had heart attacks or other cardiac issues while taking testosterone drugs have retained lawyers are expected to file lawsuits.

Do YOU have a legal claim? Fill out the form on this page now for a free, immediate, and confidential case evaluation. The testosterone attorneys who work with Top Class Actions will contact you if you qualify to let you know if an individual lawsuit or class action lawsuit is best for you. [In general, testosterone product lawsuits are filed individually by each plaintiff and are not class actions.] Hurry — statutes of limitations may apply.

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