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Ortho Evra Gets Second Safety Warning as Concerns over Blood Clots Mount

Jan 19, 2008 | Parker Waichman LLP

A second Ortho Evra Birth Control Patch study has found that the contraceptive puts users at a higher risk of blood clots than estrogen-containing birth control pills, prompting the Food & Drug Administration (FDA) to announce another round of label modifications for the Johnson & Johnson birth control patch.  This is the second time since 2006 that the Ortho Evra label has been changed over blood clot concerns.

When Ortho Evra was introduced in 2002, Johnson & Johnson touted the once-weekly patch as a convenient alternative to daily oral contraceptive pills.  The drug’s original safety label stated that the patch’s health risks were similar to those of oral contraceptives. But in 2005, the FDA warned that women using Ortho Evra were exposed to approximately 60 percent more estrogen than those who use oral contraceptive pills. High levels of estrogen can greatly increase the risk of developing blood clots, heart attacks, strokes and other serious injuries.

As of November 2005, the FDA had received twenty-one reports of life-threatening blood clots and other ailments associated with the use of Ortho Evra. Then in 2006, a study was published that showed women using Ortho Evra were twice as likely to suffer a type of blood clot called venous thromboembolisms (VTEs) -- a clot that can travel to the lungs and cause a fatal pulmonary embolism - as those taking oral birth control pills. That study prompted the FDA to request a change on the Ortho Evra label to include a stronger safety warning.

The new Ortho Evra data, from an epidemiological study conducted by the Boston Collaborative Drug Surveillance Program on behalf of Johnson & Johnson, has again found the patch doubles the risk of developing VTEs compared to the Pill. Yet despite these concerns, the FDA press release announcing the labeling changes continued to call Ortho Evra a “safe and effective method of contraception”.   Aside from the labeling change, the only other action the FDA has taken is to recommend “that women with concerns or risk factors for serious blood clots talk with their health-care provider about using Ortho Evra versus other contraceptive options."

Not surprisingly, some patient advocates don’t think the FDA warning goes far enough, and have called for Ortho Evra to be pulled from the market.  Sidney Wolfe, director of the Washington, D.C.-based consumer advocacy group Public Citizen, told Toronto's The Globe and Mail newspaper that women "shouldn't use [the patch]. It shouldn't be used because it's a new product with no unique advantage."

Since 2006, Ortho Evra has been named in well over 2000 lawsuits.  As those Ortho Evra lawsuits have made their way through the courts, evidence has been presented that Johnson & Johnson knew long before the FDA or the public that the patch put users at risk for developing blood clots.  In Ohio, lawyers have filed papers detailing two separate Ortho Evra studies that showed the patch was dangerous, but where altered or suppressed by Johnson & Johnson.   In August, the New Jersey Supreme Court released a letter written to Johnson & Johnson CEO William Weldon in 2005 by an unnamed former vice president stating that he or she had resigned from the company because of its decision to downplay safety concerns regarding Ortho Evra.  Joe Lippman, another former Johnson & Johnson employee who was fired in 2006, has testified that in the late 1990s, he raised concerns over “dangerously high levels of estrogen” that users of the patch were exposed to, but was ignored.

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