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Ortho Evra - News

September 20, 2006: FDA Announces Update to Ortho Evra Label

The U.S. Food and Drug Administration (FDA) is announcing an update to the Ortho Evra label, after the results of a recent study supported FDA's concerns regarding the potential for Ortho Evra use to increase the risk of blood clots in some women. The label has recommended (and continues to recommend) that women with concerns or risk factors for thromboembolic disease talk with their healthcare provider about using Ortho Evra versus other contraceptive options. Read Q&A on the Announcement from the FDA.

March 10, 2006: Wrongful Death Suit Filed Over Ortho Evra Patch

A wrongful death lawsuit was filed on behalf of a 20-year-old Indiana woman who suffered a fatal pulmonary blood clot after using the Ortho Evra birth control patch for 10 months. The suit, filed against Ortho-McNeil Pharmaceuticals (manufacturer of the Ortho Evra patch) alleges that Ortho-McNeil was aware of the increased risk of blood clots and related health problems in users of the patch, but failed to properly warn of those risks.

March 1, 2006: Ortho Evra Lawsuits Assigned to Federal Judge

Almost 70 federal product liability lawsuits challenging the safety of the Ortho Evra birth control patch have been assigned to a U.S. District Court judge in the Northern District of Ohio. Each of the suits allege that the Ortho Evra patch was defectively designed, and that the manufacturer of the patch (Ortho-McNeil Pharmaceuticals) failed to adequately warn users of the risks associated with use of the patch.

Nov. 10, 2005: FDA Updates Ortho Evra Patch Labeling

The U.S. Food and Drug Administration (FDA) approved updated labeling for the Ortho Evra contraceptive patch, to warn healthcare providers and patients that use of the product exposes women to higher levels of estrogen than most birth control pills. In general, increased estrogen exposure may increase the risk of blood clots. However, it is not known whether women using Ortho Evra are at a greater risk of experiencing these serious adverse events.

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