Some Doctors Stop Prescribing Ortho Evra Birth Control Patch After FDA Warning, Wall Street Journal Reports

Some doctors are no longer writing prescriptions for Johnson & Johnson's Ortho Evra contraceptive patch after FDA issued a warning earlier this month regarding possible health risks for women using the patch, the Wall Street Journal reports (Chaker, Wall Street Journal, 11/22). FDA on Nov. 8 warned that women who use the patch have a higher risk of experiencing blood clots and other side effects than previously stated because the patch exposes users to about 60% more estrogen than standard birth control pills. The Ortho Evra patch -- which is manufactured by Ortho-McNeil, a subsidiary of J&J -- is worn on the skin for one week at a time, delivering progestin and estrogen to the blood stream. The Associated Press in July reported that, according to FDA records it obtained through a Freedom of Information Act request, women using Ortho Evra in 2004 were three times as likely as women using birth control pills to die or develop nonfatal blood clots. FDA and Ortho-McNeil said they were aware of a possible increased risk of blood clots among patch users but said the patch was as safe as birth control pills (Kaiser Daily Women's Health Policy Report, 11/11). Some doctors and health care providers "don't want to take any chances" with Ortho Evra and are no longer offering new prescriptions, and others are advising their patients who currently are using the patch to switch to another form of birth control, according to the Journal. Lee Shulman, incoming board chair of the Association of Reproductive Health Professionals and a consultant to Ortho-McNeil, said a "decrease in use" of Ortho Evra can be expected. However, he said switching from the convenience of a weekly contraceptive to a daily pill might lead to unplanned pregnancies, adding, "There is no evidence that there's an increased risk of bad events" with Ortho Evra. The company currently is conducting two large-scale studies on the effects of Ortho Evra (Wall Street Journal, 11/22).


"Reprinted with permission from kaisernetwork. You can view the entire Kaiser Daily Health Policy Report, search the archives, or sign up for email delivery at kaisernetwork/dailyreports/healthpolicy. The Kaiser Daily Health Policy Report is published for kaisernetwork, a free service of The Henry J. Kaiser Family Foundation . © 2005 Advisory Board Company and Kaiser Family Foundation. All rights reserved.