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November 19, 2008

J&J Maintains Ortho Evra Safe, Reports Indicate Otherwise

Even as Johnson & Johnson has paid out at least $68.7 million in out-of-court settlements over side effects of the birth control patch Ortho Evra, they still maintain it is a safe alternative for birth control. Over twenty women have died and in excess of 4,000 have filed complaints in state and federal courts claiming Ortho Evra was responsible for and caused deep-vein thrombosis-blood clots in the legs and pulmonary embolisms-blood clots in the lungs. As of mid-October Johnson & Johnson has not released financial records of the settlements to its investors. Gloria Vanderham, a spokesman for Ortho-McNeil Pharmaceutical, Inc., that manufactures the drug for Johnson & Johnson, told Bloomberg.com, “Ortho Evra provides a needed birth-control option for women and physicians. When used according to the FDA- approved label, Ortho Evra is a safe and effective method of hormonal birth control.” However, in 2005, after investigations by the US Food & Drug Administration, the company was told to update its product label to say that Ortho Evra exposes women to 60 percent more estrogen than the typical birth-control pill and that higher estrogen increases side effects. In 2006, a federal drug safety report “indicate that in 2004 when 800,000 women were on the patch the risk of dying or suffering a survivable blood clot while using the device was about three times higher than while using birth control pills.” It is still touted as a safe alternative by the drug company.

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