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More Ortho Evra® News
Ortho Evra® will have new labeling with more information on the risk of nonfatal blood clots associated with the birth control patch.
The Ortho Evra® birth control patch label change is adding information from two observational studies. These studies publicized by the FDA are about clotting risk in women using Ortho Evra® or birth control pills containing 35 micrograms of estrogen.
The two studies included data from two insurance companies and had conflicting results. The data covered 400,000 to 500,000 women aged 15-44 using the Ortho Evra® patch or birth control pills containing 35 micrograms of estrogen.
The studies were purely observational, so it was not a direct test of Ortho Evra® as a clot cause.
The first study showed no increased risk of nonfatal clotting events such as pulmonary embolisms or deep vein thromboses with Ortho Evra® compared to birth control pills.
The second study shows that Ortho Evra® patch users were twice as likely as pill users to get nonfatal clots.
The results of both tests don't show the risk of fatal blood clots with either birth control.
Both studies were funded by Ortho McNeil and will be continued for another one to two years. The follow-up will also look at heart attack and stroke risk.
The Ortho Evra® birth control patch may expose up to 60% more estrogen than the pill containing 35 micrograms of estrogen, and that may mean a greater clotting risk. This information has been on Ortho Evra®'s label since November 2005.
Reference:
"Ortho Evra Patch: Clot Risk Update," Miranda Hitti, WebMD, September 2006.
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