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Jan. 18, 2008 -- The FDA today strengthened its warning on the risk of serious blood clots in women using the Ortho Evra birth control skin patch.
The warning about venous thromboembolism -- clots in veins that may be life-threatening if they travel to the lungs and cause pulmonary embolism -- isn't new. It's been on the Ortho Evra patch label since September 2006.
What's new is that now, the patch's label no longer notes conflicting information about that risk.
Previously, the Ortho Evra patch's label mentioned mixed results from two studies on clotting risk. One study showed that patch users were twice as likely as birth control pill users to develop venous thromboembolism. The other study showed that patch users and pill users were equally likely to develop venous thromboembolism.
Now, results from a third observational study are in, and that study shows that the odds of developing venous thromboembolism are higher for women who use the Ortho Evra patch than for women using birth control pills.
Today, the FDA ordered the results of that new study to go on the Ortho Evra patch label.
Ortho Evra patch users are exposed to about 60% more estrogen than women who use typical birth control pills, which contain 35 micrograms of estrogen. Increased levels of estrogen may increase the risk of side effects, including venous thromboembolism, according to the FDA.
In a news release, the FDA states that it "believes that Ortho Evra is a safe and effective method of contraception when used according to the labeling, which recommends that women with concerns or risk factors for serious blood clots talk with their health care provider about using Ortho Evra versus other contraceptive options."
The Ortho Evra Contraceptive Transdermal Patch is made by Ortho-McNeil Pharmaceuticals, a division of Johnson & Johnson.