New Study Shows Women Using the Ortho Evra Birth-Control Patch Double Risk of Blood Clots Compared With Those Taking Birth-Control Pill

Women using the Ortho Evra birth-control patch have twice the risk of developing blood clots than those who take the pill according to a new study funded by Ortho Women’s Health & Urology, the manufacturer of the patch.  Two studies were done and interim results from the second study suggested a two fold increase in the risk of clots in the legs and lungs, in women using the patch, Ortho said.

On Feb. 16, 2006, the Food and Drug Administration approved a revision to the label for the Ortho Evra contraceptive patch, warning doctors and patients that the product exposes women to higher levels of estrogen than most birth control pills. The new warning is the result of the study that compared the risks of developing serious blood clots in women using the Ortho Evra patch with the risks caused by typical birth control pills.[1] The studies found that women who use Ortho Evra are exposed to about 60 percent more total estrogen in their blood than if they were taking a typical birth control pill.[2]  High levels of estrogen levels are associated with an increased risk of developing potentially fatal blood clots (strokes). The company said that the risk of clots remains rare and that they have been reported as a potential risk of all hormonal contraceptives.

This new bolder warning comes just months after the Nov. 10, 2005 FDA change to the label on the Ortho Evra patch to reflect that women using it had higher risk of blood clots and other side effects because they are exposed to more estrogen than women taking the pill.  An Associated Press investigation published in July 2005 reported that women on the Ortho Evra patch were three times more likely to die or be injured by a blood clot than women on the pill.[3]   The AP report indicated that potential Ortho Evra patch deaths have been reported in about a dozen young women in 2004.[4]    According to the Associated Press, annual American sales of the Ortho Evra patch reached an estimated $400 million.[5]

The new Ortho Evra labeling information is available along with additional information for healthcare providers and consumers online at: www.fda.gov/cder/drug/infopage/orthoevra/default.htm. If you or someone you know has been injured or killed by a blood clot while using Ortho Evra patch and you wish to consult with us, please call our lawyers by sending an e-mail here: contact us.