FDA Announces Ortho Evra Label Will Include New Data On Increased Risk Of Blood Clots

Main Category: Women's Health / Gynecology
Also Included In: Blood / Hematology;  Regulatory Affairs / Drug Approvals;  Fertility
Article Date: 24 Jan 2008 - 9:00 PDT

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FDA on Friday announced that the label for the birth control patch Ortho Evra -- made by Johnson & Johnson subsidiary Ortho McNeil -- will include new data on a study that found a higher risk of blood clots among women who use the patch, Reuters Health reports. The study found that women ages 15 to 44 who use the patch are about twice as likely to have blood clots as women who use birth control pills (Reuters Health, 1/21). According to FDA, the blood clots could lead to a lung embolism (AP/USA Today, 1/18).

FDA in September 2006 updated Ortho Evra's label to include information from two conflicting studies on increased risk of blood clots among patch users (Daily Women's Health Policy Report, 9/21/06). One study suggested the patch could double the risk of a blood clot, compared with the pill, and the other found that chances of a blood clot were equal. FDA said that although the results of the three studies are "conflicting," two of the studies support the agency's "concerns regarding the potential for use of Ortho Evra to increase the risk of blood clots in some women."

According to Reuters Health, women who use Ortho Evra are exposed to about 60% more estrogen than pill users. However, FDA officials have said that the risk of developing blood clots while using hormonal contraceptives is low -- for every 10,000 women who use a hormonal contraceptive for one year, about three to five will develop a clot.

FDA said it believes that Ortho Evra is safe and effective when used according to the labeling and recommended that women who have risk factors for blood clots speak with their doctors before using the patch (Reuters Health, 1/21). "For women that choose to use contraceptives, it is important that they thoroughly discuss with their health care providers the risks and benefits involved," Janet Woodcock, FDA's deputy commissioner for scientific and medical programs, said (AP/USA Today, 1/18).

J&J in a statement said it worked with FDA to change the label. "Ortho Evra, like all hormonal birth control, has risks and benefits. It is important that women speak to their health care professional to determine the option that is right for them," J&J said (Reuters Health, 1/21).

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