FDA Issues Warning Against J&J's Ortha Evra Birth Control Patch

Main Category: Women's Health / Gynecology
Article Date: 12 Nov 2005 - 17:00 PDT

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FDA on Tuesday warned that women who use Johnson & Johnson's Ortho Evra contraceptive patch have a higher risk of experiencing blood clots and other side effects than previously stated because the patch exposes users to higher levels of estrogen than regular birth control pills, the AP/Washington Post reports. In a "strongly worded" label addition, FDA said patch users are exposed to about 60% more estrogen than women who use standard birth control pills, according to the AP/Post (Mendoza, AP/Washington Post, 11/11). 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. J&J in March launched print and television advertisements for Ortho Evra featuring doctors who discuss risks associated with the patch (Kaiser Daily Women's Health Policy Report, 9/15). Ortho-McNeil currently is conducting studies of the patch that compare the risk of blood clots among patch users to that among women who are taking regular birth control pills that contain 35 micrograms of estrogen, according to FDA (Reuters, 11/10). More than four million women have used the Ortho Evra patch since it reached the market three years ago. Several families of women who have died or suffered blood clots while using the patch have filed lawsuits against the company, and attorneys said more are expected (AP/Washington Post, 11/11). FDA on Thursday said it intends to continue tracking the patch for safety problems (Reuters, 11/10).

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

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