OrthoEvra labeling change
Updated labeling for OrthoMcNeil's contraceptive patch OrthoEvra will include results of a new epidemiology study that shows a higher risk of developing serious blood clots with the patch than with birth control pills., firm announces Jan. 18. The results support earlier studies and a warning that was added to labeling in 2005, noting that the transdermal formulation had higher exposure to contraceptive hormones than oral products. In 2006, the warning was revised with two epidemiology studies - one showing a higher risk of venous thromboembolism with the patch and one showing no difference based on the route of administration...
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