FDA Alerts on Birth Control Devices

In November of 2005, the FDA approved updated labeling for the Ortho Evra patch to warn women of the product's health dangers. This new FDA alert was prompted by the higher levels of estrogen and progestin hormones in Ortho Evra users than in users of typical birth control pills.

Increased estrogen exposure has been linked to an increase in the risk of blood clots that can cause serious health problems. Although it has not been determined if women using Ortho Evra are at a greater risk of experiencing these problems, the FDA felt it necessary to inform women of the increased estrogen exposure associated with Ortho Evra usage. Both the FDA and the Ortho McNeil, the manufacturers of Ortho Evra, are continuing to monitor safety reports for the Ortho Evra patch.