Studies Disagree on Ortho Evra's Blood Clot Risk
September 21, 2006
WASHINGTON, D.C. - The FDA is notifying healthcare professionals and patients about two epidemiological studies on Ortho Evra that are showing varied results on whether the birth control patch increases the risk of blood clots.
Ortho-McNeil is updating the patch's label to include the results of the studies, one of which found that the risk of non-fatal venous thrombeoembolism (VTE) is similar to the risk associated with using oral contraceptives. The other study found a two-fold increase in the risk of medically verified VTE events in patch users as compared to users of oral contraceptives.
"Although the results of the …
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