What steps has the FDA taken?
Doctors at the FDA recommended a warning label to reflect this increased risk of a serious drug reaction, and follow-up studies to monitor clot problems after it was introduced on the market. Ortho-McNeil Pharmaceuticals failed to implement either of these recommendations. In November 2005, following publication of the AP article, the FDA required Ortho McNeil to update its label on the Ortho Evra contraceptive patch. The FDA’s press release stated that, “The new bolded warning specifically states that women who use Ortho Evra are exposed to about 60 percent more total estrogen in their blood than if they were taking a typical birth control pill containing 35 micrograms of estrogen.
Doctors at the FDA recommended a warning label to reflect this increased risk of a serious drug reaction, and follow-up studies to monitor clot problems after it was introduced on the market. Ortho-McNeil Pharmaceuticals failed to implement either of these recommendations. In November 2005, following publication of the AP article, the FDA required Ortho McNeil to update its label on the Ortho Evra contraceptive patch.
