FDA Panel Says Johnson & Johnson’s Ortho Evra Patch Benefits Outweigh Risks

It was reported Friday in the media that an FDA Advisory panel determined that Johnson & Johnson’s Ortho Evra birth control patch showed its benefits outweighed the risk of blood clotting.

A single Ortho Evra patch is applied continuously, once a week, for three consecutive weeks, followed by one week patch-free. Ortho Evra was the first skin patch approved for birth control. Panelists say that the patch can be especially useful and convenient for younger women who have difficulty sticking to a daily pill regimen. This patch was approved in 2001 and has been marketed for its convenience as an “option for busy women who are looking to simplify life.” The drug works about as well as other contraceptive medications, allowing about one unplanned pregnancy per year for every 100 women.

Studies have found that the patch carries a higher risk of blood clots than lower dose hormonal pills.  The FDA’s panel of reproductive health experts voted 19-5 that the benefits of the Ortho Evra patch outweighs its risks, specifically, a potentially higher risk of dangerous blood clots in the legs and lungs.  However, panelists voted 20-3 (with one abstention) that the drug’s label is inadequate.  Johnson & Johnson has made many changes in the labeling of the product over the past six years since settling claims totaling about $68.7 million.  Studies assessing Ortho Evra’s blood clot risk have reached differing conclusions over the years. In at least two studies, it was found that patch users have twice the risk of blood clots as women taking birth control pills. Even a slightly higher risk can be most critical since blood clots can trigger sudden heart attacks, strokes and blockages in heart, lungs or blood vessels, which can be fatal, even in young women.

Despite the safety concerns, experts stressed that this patch fills a unique niche among birth control options.  “There is no alternative in this range for women who desire hormonal contraception but can’t take the pill, so I think it is important to maintain that option,” said Dr. Michele Orza of the George Washington University.

Prescriptions for Ortho Evra have declined steadily over the last five years, from 5 million in 2006 to about 1.3 million last year. The decline has followed repeated updates by Johnson & Johnson as to the product’s labeling, including language explaining that patients absorb up to 60% more estrogen from the patch than from the pill.  Ortho Evra sales last year totaled $124 million.

On Thursday, the same panel recommended clearer risk labeling on YAZ, Yasmin, and similar birth control pills marketed by Bayer and Teva Pharmaceuticals, while arriving at the conclusion that the benefits outweighed the risks of blood clots.

It is great to know that there are benefits to something so convenient. As with all medications, there are risks involved, and you must weigh the risks compared to the benefits. Do you see yourself buying this product? Leave us some feedback on our Facebook page, or Retweet this article. You may also stop by our website, or contact one of our attorneys at 1-800-246-4878 if you have any questions.

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