Possibly Increased Risk Of Blood Clot-Related Side Effects Like PE And DVT Suggested By Postmarketing Studies

(Posted by Tom Lamb at DrugInjuryWatch.com)

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 UPDATE:  Ortho Evra: December 2011 FDA Advisory Committees Meeting Background Materials Now Available Online

(12/7/11)

UPDATE:  Ortho Evra Update: October 2011 FDA Study Finds Increased Risk Of Serious Blood Clot Side Effects Like Pulmonary Embolism (PE) And Deep Vein Thrombosis (DVT)

(11/2/11)

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On December 9, 2011 there will be a joint meeting of the FDA's Reproductive Health Drugs Advisory Committee and the FDA's Drug Safety and Risk Management Advisory Committee to discuss the benefits and risks of the Ortho Evra birth control patch (norelgestromin/ethinyl estradiol transdermal system).

According to the FDA's Meeting Announcement:

Specifically, the committees will discuss the possibly increased risk of thrombotic (blood clots) and thromboembolic events (blood clots that can break loose and move within the circulatory system) in users of ORTHO EVRA compared to women who use commonly prescribed birth control pills, as suggested by postmarketing studies.

In March 2011 the so-called "Black-Box" part of the Ortho Evra label, or package insert, was revised to give a stronger warning about blood clot-related side effects like pulmonary embolism (PE) and deep vein thrombosis (DVT).

We will continue to monitor the safety profile of the Ortho Evra birth control patch and look forward to hearing the discussions at this December 2011 FDA Advisory Committees meeting.

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