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Lawsuit Alleges testosterone-boosting Fortesta gel Caused Man’s Heart Attack

Filed May 12th, 2014 Eric

A man and his wife have filed a lawsuit against Endo Pharmaceuticals Inc. and Prostrakan Group PLC, alleging that their testosterone-boosting Fortesta gel led to the man’s heart attack.

Demetric Taylor and his wife filed the lawsuit in Philadelphia Court of Common Pleas. It is believed to be the first case of its kind in that court. The lawsuit alleges that Fortesta, which was developed by Prostrakan and licensed to Endo for sales in the U.S., is an unneeded drug advertised commercially to treat a disease that does not exist, Law 360 reported.

The lawsuit claims the advertisements suggest that multiple symptoms often associated with other conditions may be caused by low testosterone and attempt to convince men to talk to their doctor about testosterone replacement therapy if they experienced any of the symptoms of low testosterone. “The symptoms the advertisements list include “listlessness, increased body fat and moodiness — all general symptoms that are often a result of aging, weight gain or lifestyle, rather than low testosterone,” the lawsuit said according to Law 360.

Taylor alleges that he and his doctor had relied on claims made by Endo and Prostrakan that low testosterone was a real disease that needed to be treated when he decided to take the drug. Taylor also claims the defendants did not fully disclose the risks of Fortesta in their marketing, Law 360 reported.

Taylor did not reveal in the complaint when his heart attack occurred.

Testosterone products have been linked to a variety of serious side effects, including possible increased cancer risks, enlarged prostate, high blood pressure, lowered sperm count, body swelling, blood clots in legs, sleep apnea, skin irritation, increased cholesterol levels and increased red blood cell count.

The U.S. Food and Drug Administration (FDA) has only approved testosterone drugs for men who either no longer produce testosterone or have very low amounts. However, the ambiguity of the statement has left room for companies to advertise their product in a way to convince healthy men that they need to product.

No long-term study has ever been conducted to assess the safety or effectiveness of these drugs and many in the medical community find them to be completely unnecessary for most men. As the scrutiny over the drugs picks up, increased litigation may follow.

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