A new study has found that users of the Ortho Evra birth control patchhad twice the risk of venous thromboembolic events, or blood clots in the legs and lungs, as users of more traditional birth control pill methods. The results of the study were made public February 16, 2006, by the patch’s manufacturer, Ortho Women’s Health & Urology, a subsidiary of Johnson & Johnson. A second study made public by the manufacturer found no increased risk of clots in patch users.

Dr. Daniel Shames of the U.S. Food and Drug Administration says that the confidence intervals of the results for the two forms of contraceptive, the patch and the pill, overlap. Tere actually may be more than double the risk of blood clots from the patch as from the pill in most users. The normal risk of a nonfatal blood clot is about one per year per 10,000 women not using a contraceptive. For women on the pill, the risk rises to between three and five. In the study cited showing a risk, there were two reports of blood clots among only 3,000 women.

The FDA has urged concerned women to discuss the risks of the Ortho Evra patch with their doctors but has taken no action at this time to recall the patch.

Source: Randolph E. Schmid, “Study criticizes patch,” Associated Press, February 18, 2006.