The FDA updated the warning label on the Ortho Evra birth control patch after results of a new study found woman using the patch were twice as likely to develop blood clots, than those taking birth control pills. Johnson & Johnson is already facing over 500 suits from women who claim Ortho Evra caused serious side effects including blood clots, pulmonary embolism, deep venous thrombosis, stroke, heart attack, paralysis and even death. The new warning could spur a new round of lawsuits against McNeil Pharmaceuticals, a division of Johnson & Johnson.
The new study validates an investigation conducted last year by the Associated Press, which found high rates of blood clots in women using the patch. Last November, the FDA updated the label on Ortho Evra to alert women that using the patch exposes them to about 60 percent more estrogen than using birth-control pills. Johnson & Johnson has said in the past that blood clots associated with Ortho Evra are rare, and the risk is similar to those of oral contraceptives.
The company reported in filings made last month that Ortho Evra sales have declined significantly following the previous label revision and a spate of media coverage of the clot issue. Since the patch went on sale in 2002, more than 4 million women have used it.
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