Warnings Issued and Label Change forced by FDA

On November 10, 2005, the U.S. Food and Drug Administration issued a warning to users of the Ortho Evra birth control patch. The FDA warned Ortho Evra users that in using the birth control patch, they are exposed to higher levels of estrogen thereby increasing the risk of blood clots and other serious adverse events. The FDA also ordered Ortho McNeil to add a bolded warning about such increased risks to the Ortho Evra labeling.

According to data released as part of the new warnings, while the amount of estrogen in the Ortho Evra patch and traditional oral contraceptives is relatively the same, the steady state blood concentration of ethinyl estradiol, an estrogen compound, is 60 percent greater when using the Ortho Evra birth control patch as opposed to using traditional oral contraceptives. The probable explanation for the difference is the Ortho Evra patch's transdermal delivery system. With oral contraceptives, approximately half of the estrogen is lost in a woman's digestive tract. In contrast, the estrogen delivered with the Ortho Evra patch is dispersed directly into the bloodstream which, according to newly published studies, accounts for 50 percent more absorption of estrogen.

On February 16, 2006, the manufacturer of the Ortho Evra® birth control patch disclosed the results of an unpublished epidemiological study supporting the belief that the use of the Ortho Evra® birth control patch poses a greater risk of developing blood clots than that posed by oral contraceptives. The recent study, funded by the manufacturer of the Ortho Evra® birth control patch, concludes that, when compared to oral contraceptives, the use of the Ortho Evra® birth control patch doubles the risk of developing venous thrombosis (blood clots and deep vein thrombosis). This increased risk is believed to be attributable to the transdermal hormonal delivery system that is unique to the Ortho Evra® birth control patch. The transdermal patch delivers estrogen directly into a woman’s blood stream whereas oral contraceptives provide estrogen through the digestive system. Absorption through the blood stream is greater and more rapid than absorption through the digestive system. 

On February 17, 2006, the FDA held a news conference to assure the public that the FDA is monitoring the results of this and other studies designed to study the risk of blood clots and other thromboembolic injuries (e.g. pulmonary embolism, heart attack, stroke, sudden death) and the use of the Ortho Evra® birth control patch. However, Daniel Shames, M.D., director of the FDA’s Division of Reproductive and Urologic Drug Products, said “At this time we do not plan on taking any specific regulatiry action based on these preliminary results.”


FDA links

- Updated FDA Labeling Release
- Ortho Evra Questions and answers
- Patient Information Sheet


If you or a loved one has suffered a heart attack, stroke, sudden cardiac death, or a pulmonary embolism while using the Ortho Evra Patch and have questions about your legal rights, fill out our free case evaluation form.