More FDA Warnings Added to Ortho Evra Label Regarding Increased Blood Clot Risk

Weitz & Luxenberg is no longer accepting ReNu with MoistureLoc cases.

September 20, 2006

The U.S. Food and Drug Administration (FDA) announced that it had added updated warnings to the prescribing information for the Ortho Evra birth control patch.  The Ortho Evra patch is manufactured by Ortho Women's Health & Urology, a company owned by Johnson & Johnson.

The FDA's updated warning comes in response to two separate studies sponsored by the pharmaceutical company that were designed to evaluate the risk of developing a serious blood clot when using the Ortho Evra patch as compared to women using a different oral contraceptive.

The results of one study found that women using the Ortho Evra patch faced twice the risk of clots than did women using the pill. The FDA has requested longer follow-up for venous thrombo-embolism, heart attack and stroke.

Prescribing information for the Ortho Evra patch continues to recommend that women with concerns or risk factors for thromboemboli disease speak with with their healthcare professionals about the use of the Ortho Evra patch versus other contraceptives.

The new bolded warning advises women who use the Ortho Evra patch that they are exposed to about 60 percent more total estrogen than if they were taking a typical birth control pill containing 35 micrograms of estrogen. The warning further explains that when using the Ortho Evra patch, a women's estrogen blood level remains constant for one week until the patch is removed.  In women taking a daily birth control pill, the peak blood levels rapidly decline to levels that are lower than on Ortho Evra.

Have you been harmed by the Ortho Evra birth control patch? We may be able to help. One of our leading drug and medical device lawyers can help you file a lawsuit against the manufacturer.

It is essential that you file soon to meet the legal deadlines. Our simple form below will start the process.

Weitz & Luxenberg is no longer accepting ReNu with MoistureLoc cases.

see also:

FDA Warning, 1.18.08 FDA: Ortho Evra Users at Higher Risk for VTE and Pulmonary Embolism
FDA Changes Ortho Evra label after second study cites pulmonary risk

Ortho Evra Lawyers Know the Health Risk Associated With Ortho Evra Birth Control: Lawyers
Our defective drugs lawyers can help you file your Ortho Evra case

Updated FDA Warnings FDA Continues to Update Warnings to Label of Ortho Evra--attorney info
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