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More FDA Resources
What did the FDA announce on September 20, 2006?
The Food and Drug Administration (FDA) recently announced an update to the Ortho Evra® birth control patch label with the results of two epidemiology studies sponsored by Johnson & Johnson. The studies were designed to evaluate the risk of experiencing serious side effects, such as blood clots, when using Ortho Evra®.
Is this information new for the Ortho Evra® patch?
Some of the information being added to the Ortho Evra® label was previously reported by Johnson & Johnson in February of 2006. Information that was previously released was based on an interim report from one of the studies. The Ortho Evra® label is now being updated with the results from both studies.
Why were these Ortho Evra® studies done?
The two epidemiology Ortho Evra® studies were conducted to evaluate the risk of developing a serious blood clot when using the Ortho Evra® patch compared to the most common birth control pills. Concern about this risk was originally based on reports of serious blood clots to the FDA that suggested Ortho Evra® may have a greater risk for venous thromboembolism (VTE) compared to the birth control pill.
What information was found in the two Ortho Evra® studies?
The results of both Ortho Evra® studies are different, but each study used electronic health care claims data.
The first Ortho Evra® patch study was conducted by the Boston Collaborative Drug Surveillance Program. This study found that the risk of non-fatal VTE events associated with the use of Ortho Evra® is similar to the risk associated with the use of birth control pills containing 35 micrograms of estrogen.
The second Ortho Evra® study was conducted by i3 Ingenix. This study found an approximate 2-fold increase in the risk of medically verified VTE events in users of the Ortho Evra® patch compared to users of birth control pills containing 35 micrograms of estrogen.
What other actions has the FDA taken with regard to the Ortho Evra® birth control patch?
In November 2005, the FDA added information to the Ortho Evra® label about the increased exposure to estrogen in women who use the Ortho Evra® patch compared with birth control pills.
If someone wants to change from Ortho Evra® to a birth control pill, what should they do?
Talk to their health care professional.
Where can I find more information on Ortho Evra®'s risk?
You can contact the Center for Drug's Division of Drug Information at: 888-INFO-FDA (888-463-6332) or druginfo@fda.hhs.gov.
Reference:
"Questions and Answers - Ortho Evra (norelgestromin/ethinyl estradiol)," FDA, September 20, 2006.
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