Women's Health News & Views

Ortho Evra Birth Control Patch Users Twice as Likely To Develop Blood Clots as Women Taking Oral Pills, Manufacturer-Funded Study Says

Women who use the Ortho Evra birth control patch -- which is manufactured by Ortho-McNeil, a subsidiary Johnson & Johnson -- are about twice as likely to develop blood clots as women taking oral birth control pills, according to interim results from an Ortho-McNeil-funded study released on Thursday, the AP/Houston Chronicle reports (Bridges, AP/Houston Chronicle, 2/17).

The study -- which was conducted by i3 Drug Safety, an Ingenix subsidiary -- compared the combined risk of heart attack, stroke and blood clots in the legs or lungs in women taking Ortho Evra and women taking oral contraceptive pills containing norgestimate and estrogen. The study did not find an increased combined risk for heart attack and stroke in women taking Ortho Evra, but patch users had about double the risk of blood clots as the women taking the pills (Ortho-McNeil release, 2/16). A separate manufacturer-funded study comparing Ortho Evra users to pill users examined a database of 200,000 women and showed that the risk of blood clots was similar between the two groups (Corbett Dooren, Dow Jones, 2/16). That study, which was conducted by the Boston Collaborative Drug Surveillance Program and published in the Jan. 30 online edition of the journal Contraception, also did not find an increased risk for heart attack and stroke among women using Ortho Evra, but evaluation of the data is ongoing (Ortho-McNeil release, 2/16).

The company said the data from both studies have been given to FDA (AP/Houston Chronicle, 2/17). FDA in November 2005 warned that women who use Ortho Evra 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 birth control pills. The Associated Press in July 2005 reported that, according to FDA records it obtained through a Freedom of Information Act request, women using the patch in 2004 were three times as likely as women using birth control pills to die or develop nonfatal blood clots. The patch is worn on the skin for one week at a time, delivering progestin and estrogen to the blood stream (Kaiser Daily Women's Health Policy Report, 11/22/05).

Reprinted with permission from kaisernetwork.org. You can view the entire Kaiser Daily Women's Health Policy Report, search the archives, and sign up for email delivery at www.kaisernetwork.org/dailyreports/women. The Kaiser Daily Women's Health Policy Report is published for kaisernetwork.org, a free service of The Henry J. Kaiser Family Foundation. (c) 2005 Advisory Board Company and Kaiser Family Foundation. All rights reserved.