September 20, 2006: FDA Announces Updates about Ortho Evra Label
US Food and Drug Administration is posting their update about the Ortho Evra label as a result to the findings of a recent study that supported the concerns of FDA about the potential risks of blood clots in some women while using Ortho Evra. FDA recommended that the new label should contain warning about women who have issues or risk factors for thromboembolic illness should discuss with their healthcare provider about using the Ortho Evra and other contraceptive methods. You can read the Q & A regarding the announcement from the FDA.
March 10, 2006: Wrongful Death Suit Filed Over Ortho Evra Patch
There was a wrongful death lawsuit that was filed on behalf of the 20-year-old Indiana woman who suffered a deadly pulmonary blood clot after using the Ortho Evra birth control patch for ten months. The lawsuit was filed against the Ortho-McNeil Pharmaceuticals, the manufacturer of the Ortho Evra patch, with the claim that Ortho-McNeil Pharmaceuticals knew about the potential increased risks of blood clots and other related health issues in users of the patch, however, they were unable to give adequate warning about these risks.
March 1, 2006: Ortho Evra Lawsuits were Assigned to Federal Judge
Most of the 70 federal product liability lawsuits were questioning the safety of the Ortho Evra birth control patch were assigned to a US District Court judge in the Northern District of Ohio. Every lawsuit claimed that the design of the Ortho Evra was defective, and Ortho-McNeil Pharmaceuticals, the manufacturer of the patch, was unable to give sufficient warning to udders of the potential risks associated with the use of the patch.
November 10, 2005: FDA Updates Ortho Evra Patch Labeling
US Food and Drug Administration or FDA approved the new labeling for the Ortho Evra contraceptive patch that give warning to the healthcare providers and users about the high risks of increasing the estrogen levels compared to other contraceptive methods. Generally, the increased estrogen level may lead to blood clots. It is not known, however, if women using Ortho Evra are at higher risks of suffering the severe adverse effects.
FDA Press Release (11/10/05)
Q&A from the FDA on Labeling Changes