FDA announces update to Ortho Evra patch label

On Sept. 20, 2006 the U.S. Food and Drug Administration (FDA) announced a new and updated label that will reflect the results of two research trials into the dangers of the Ortho Evra patch. This is the first update since Nov. 10, 2005 when the FDA first officially recognized the serious side effects. The transdermal birth control patch, which delivers hormones directly into a woman’s bloodstream through the skin, has previously been found to increase the risk of potentially deadly blood clots for women who use it.

The reason is not confirmed, but most scientists suspect that blood clots are caused by the elevated levels of hormones. Originally, the Ortho Evra patch was touted to be superior to the Pill, the popular oral contraceptive, because Pill users experienced a high spike in their hormone levels including estrogen immediately after taking it. Previous research has shown connections between high levels of estrogen and blood clots.

But after the initial spike, Pill users tend to have a much lower level of estrogen in the bloodstream throughout the rest of the day. Ortho Evra patch users, on the other hand, keep a steady level throughout the week – and these higher levels are thought to be the cause of the blood clots.

For this latest FDA label update, the administration added information on two Johnson and Johnson studies that used electronic health claims data. One study found that there was no apparent raised risk of blood clots between users of the Pill and users of the Ortho Evra patch. However, the second study found that the risk increased by two times. The administration took the second study most seriously because it supports “FDA’s concerns regarding the potential for Ortho Evra use to increase the risk of blood clots in some women.”

There have been several deaths connected with the Ortho Evra patch, including one 14-year old girl in Wisconsin. At least a dozen lawsuits have been filed against its manufacturer, Ortho McNeil (a subsidiary of Johnson and Johnson) and over 30 families are rumored to have accepted confidential settlements – one of which was estimated at $10 million.

If you or a loved one has suffered complications from the Ortho Evra patch including blood clots and associated medical problems, a Jim S. Adler & Associates personal injury attorney may be able to help. We have over 30 years of medical law experience in Texas, and we can help you defend your rights – and get the compensation you deserve for your injuries. Don’t sign any settlements until you talk to us first. Call us directly or click on the link below to submit your Ortho Evra patch case for a full and free case review.

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