The FDA approved updated labeling for the Ortho Evra contraceptive patch, in order to warn healthcare providers and patients that the patch exposes women to higher levels of estrogen than most birth control pills. In general, increased estrogen exposure may increase the risk of blood clots and strokes in some patients, although the FDA has been hesitant to state definitively whether there is a greater risk of these adverse events in women using the Ortho Evra patch.

The new bolded product label warning states that women who use Ortho Evra are exposed to about 60% more total estrogen in their blood than if they were taking a typical birth control pill containing 35 mcg. of estrogen. The FDA has stated that it will continue to monitor safety reports for the Ortho Evra patch. Ortho McNeil, manufacture of the Ortho Evra patch, is conducting additional safety studies to compare the risk of developing serious blood clots in women using Ortho Evra to the risk in women using typical birth control pills. Several women have developed serious blood clots, leading to strokes and other adverse events, while using the Ortho Evra patch.

Source: FDA Release, November 10, 2005.