Important Information Concerning Ortho-Evra Birth Control Patch

The Food and Drug Administration issued a warning to users of Ortho Evra, a birth control patch. The warning notes that users of the patch are exposed to an estrogen dose that is up to 50-60% greater than initially thought. Ortho Evra was thought to expose users to a dose of estrogen equivalent to that of typical "low dose" oral contraceptive pills. Follow up data now suggests higher doses of estrogen are absorbed by patch users and MAY increase their risk of blood clots, stroke, heart attack, and death.

The FDA warning follows news media reports including one from the Associated Press linking higher estrogen levels from the patch and blood clots. This was based on their review of reported adverse outcomes among patch users and not from a prospective clinical study. Katherine LaGuardia, MD, director of medical affairs for Ortho Women's Health notes, "The mortality rate associated with Ortho Evra use cited in the Associated Press story is misleading because it is based on spontaneous reports and inaccurate citation of clinical data. Spontaneous reports can come from various sources and there is a significant amount of uncertainty regarding the validity of their information." The company notes that there were no deaths reported during their clinical trials of Ortho Evra.

Low dose combination birth control pill use results in 1 death per 200,000 women, and the Associated Press concluded that that rate may be three times higher in patch users or 3 per 200,00 women. Neither birth control nor pregnancy is without risk. The risk of dying from a pregnancy carried beyond 20 weeks is 20 to 25 deaths per 200,000 women or about 8-25 times more often than patch users.

Some women, of course, should not take combination contraceptives such as the Ortho Evra patch. They include:

• Women who smoke cigarettes, especially for women greater than 35 years old
• Women with a previous or current blood clot either in the leg or a lung
• Some women with high blood pressure
• Women with markedly abnormal function of the liver
• Some women with diabetes
• Women who suffer prolonged immobilization, such as after major surgery
• Women who have just given birth. Hormonal contraceptives should be started no earlier than four weeks after delivery in women who are not breastfeeding.
• Women with a history of migraines with auras

If you are an Ortho Evra patch user and are concerned about the increased dose of estrogen in your contraceptive, you should schedule a time to consult with your provider about the new data and review your contraceptive choices to reduce or eliminate estrogen use. There is no immediate need to discontinue patch use since it is effective to prevent, and much safer than, pregnancy.

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