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Five women who claim to have suffered harm from injections of Lupron for treatment of endometriosis are suing the drug’s manufacturer, Tap Pharmaceuticals, in U.S. federal court.

Samuel Bearman of Pensacola, Florida, one of two attorneys for the plaintiffs, told that the pre-trial discovery process is expected to begin shortly.

The five women claim, for example, that Tap Pharmaceuticals failed to properly test Lupron, failed to warn government agencies, including the FDA, of the results of company testing, failed to warn consumers of the dangers associated with Lupron, concealed the known dangers associated with Lupron, and failed to warn the physicians prescribing Lupron of its known dangers.

Tap Pharmaceuticals has steadfastly maintained over the years that Lupron is safe.

The FDA first approved Lupron in 1985 for treatment of men with advanced prostate cancer, and then approved it for treatment of endometriosis in 1990 and, in 1995, for the pre-operative treatment of anemia resulting from heavy bleeding associated with fibroids.

An estimated 7 million women in the U.S. suffer from endometriosis, a condition in which pieces of the lining of the uterus are found in other parts of the body, especially in the pelvic cavity. These pieces of endometrium respond to the menstrual cycle and bleed. Because the blood cannot escape, it builds up and causes the development of small or large painful cysts.

Lupron is a synthetic hormone that is said to act on this process by suppressing the ovaries and is supposed to temporarily interrupt estrogen output. This creates a drug-induced menopause. The goal of treatment is to shrink any lesions produced via endometriosis.

Many women with endometriosis who have been given Lupron injections have had severe side-effects, including cardiac arrhythmias, dizziness, swelling, chest pain, depression and confusion, bone pain, extreme fatigue, vision loss, high blood pressure, and nausea. Some of the women claim their side- effects last long after treatment is completed.

The plaintiffs in the lawsuit against Tap claim, for example, to have experienced serious injury after Lupron injections, “resulting in pain and suffering, disability, disfigurement, mental anguish, loss of the capacity for enjoyment of life, expense of medical care and treatment, loss of earnings, loss of the ability to earn money.”

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