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Plaintiff Blames Axiron for Pulmonary Embolism

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On October 6, 2014, plaintiff James A. Foley filed a new testosterone lawsuit against Eli Lilly & Company. The case was filed in the U.S. District Court for the District of Minnesota.

According to his complaint, Foley experienced serious side effects after taking the testosterone drug Axiron. He seeks damages in excess of $75,000.

Man Suffers Blood Clots After Taking Axiron

The plaintiff in this case was using Axiron, a product manufactured by Eli Lilly & Company. A prescription medication intended to treat men with low testosterone levels, it’s a topical solution meant to be applied to the underarm, similar to a deodorant.

The FDA approved Axiron in November 2010 for the treatment of low-testosterone in men who had either primary hypogonadism or hypogonadotropic hypogonadism—both medical conditions that result in decreased levels of the male hormone.

The plaintiff was 70 years old when he started taking the drug in April 2011. He states in his case that he used it as directed to treat symptoms he believed were caused by a low level of testosterone. On October 11, 2012, he was hospitalized for both deep vein thrombosis (DVT) and pulmonary embolism—a blood clot in the lung. This is a very serious and life-threatening condition. As a result of these events, the plaintiff claims that he will now have to take medication the rest of his life to prevent any additional vascular incidents, and is now at an increased risk for serious cardiovascular problems, including heart attack, stroke, and possibly death.

Had the manufacturer more clearly identified the risks of the drug, the plaintiff claims he never would have taken it, or at least would have checked with his doctor more often to monitor his health.

Studies Show Men Taking Testosterone at Risk

Axiron and other testosterone replacement medications have been under scrutiny lately because of their potential to increase risk of cardiovascular problems. In July 2010, the New England Journal of Medicine published a study concluding that older men with conditions like high blood pressure, diabetes, high blood cholesterol, and obesity were more likely to suffer cardiovascular-related events if they were taking testosterone than if they weren’t. The effect was so prominent that the researchers stopped the study prematurely to protect the patients.

Manufacturers of Axiron and other similar drugs have advertised their products as solutions for symptoms like fatigue, muscle loss, sexual dysfunction, and other conditions that may be attributed to a number of things—even natural aging—not necessarily low testosterone. Yet the advertisements encouraged even healthy men without hypogonadism to ask their doctors about a prescription.

In November 2013, the Journal of the American Medical Association (JAMA) published another study showing that men taking testosterone were at an increased risk for heart attack and stroke. In January 2014, PLoS One published yet another that observed data from over 55,000 men. They found that younger men who had a history of heart disease were twice as likely to suffer a heart attack in the first 90 days after starting testosterone treatment. All men over the age of 65, regardless of pre-existing cardiovascular disease, were twice as likely to suffer a heart attack if they were taking the drug.