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Eli Lilly Faces Lawsuit Over Testosterone Drug Axiron

Oct 2, 2014

In a recently filed lawsuit, Eli Lilly is accused of deceptively marketing the testosterone replacement drug Axiron while failing to warn about the risk of heart attack and stroke. The suit, which was filed in federal court in Newark, New Jersey, alleges that Lilly engaged in aggressive marketing by describing symptoms of “Low-T”, which is not a true medical condition.

The case was filed on behalf of a New Jersey man who started taking Axiron in September 2012. Axiron caused the man to suffer from a heart attack on October 3, 2012 at the age of 54, the suit alleges.

As the suit points out, testosterone replacement products are only approved for men with hypogonadism, a medical condition where the body does not produce enough testosterone. Drug companies such as Eli Lilly, however, have been marketing testosterone products to treat symptoms of “Low-T” and describe symptoms such as decreased sexual desire, erectile dysfunction, fatigue and loss of energy, depressed mood, decreased need to shave, decreased strength and osteoporosis. According to the lawsuit, Lilly used aggressive marketing to solicit men who do not have a real medical condition; the symptoms of so-called Low-T are the effects of aging and weight gain, the suit states. Furthermore, the company allegedly failed to warn that testosterone products can increase the risk of heart attack and stroke.

Using a drug for any purpose not approved by the U.S. Food and Drug Administration (FDA) is known as “off-label”. While doctors can prescribe drugs off-label at their own discretion, it is illegal for companies to market their products for unapproved uses.

Testosterone drugs have been under increased scrutiny in light of research linking the products to an increased risk of cardiovascular events. The FDA announced that it would be investigating this issue in January. Similar reviews were launched by Health Canada and the European Medicines Agency (EMA). The reviews were prompted by two studies showing an increased risk of cardiovascular events with the use of testosterone replacement products. A study published last November in the Journal of the American Medical Association (JAMA) found that older men were more likely to suffer from heart attack if they took testosterone. Another study published in PloS showed that older men and younger men with a pre-existing heart condition had an increased risk of heart attack with the use of testosterone.

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