Ortho Evra Heart Attack/Stroke Risk Final Results Due In 2007, FDA Says
This article was originally published in The Pink Sheet Daily
Executive Summary
Preliminary analysis suggests two-fold greater risk of blood clots associated with J&J/Ortho-McNeil's transdermal contraceptive patch than with traditional oral contraceptives.
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Ortho Evra Label Update Includes Study Data On Blood Clot Risk
FDA requests J&J conduct longer follow up studies on the risk of serious blood clots, heart attack and stroke associated with the birth control patch.
Ortho-McNeil Conducting Additional Studies To Assess Ortho Evra Blood Clotting Risks
The firm updated labeling to include a new bolded warning regarding increased hormone exposure with the patch versus oral contraceptives.