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The Ortho Evra birth control patch was approved by the FDA as a safe and effective birth control method in November 2001. The makers of the Ortho Evra birth control patch, Ortho McNeil (a subsidiary of Johnson and Johnson) has pumped millions of dollars into an aggressive Ortho Evra marketing campaign with catch phrases like, “On your body, off your mind” and “Just peel, stick, and go.” They have offered Ortho Evra birth control patch coupons directly to consumers and have secured celebrity endorsement for their product. As a result, more than five million women have used the Ortho Evra birth control patch since it was first approved for use in the United States.

Many people are now beginning to worry that the FDA and Ortho McNeil have downplayed, or downright ignored, serious risks associated with the Ortho Evra birth control patch. In mid-2005, the Associated Press published information about the serious risks associated with the Ortho Evra birth control patch. Through the Freedom of Information Act, the AP gained access to the FDA’s adverse drug reports about the Ortho Evra birth control patch.

Prior to the commencement of this study, Ortho McNeil conducted a pre-approval clinical study involving 3,300 women using the Ortho Evra birth control patch. Two women in this study were treated for blood clots which has traveled to their lungs, a severely life threatening condition. Some doctors worried then that the Ortho Evra birth control patch posed a risk of blood clot development. The FDA and Ortho McNeil maintained that the Ortho Evra birth control patch was as safe as combination birth control pills and the drug was placed on the market.

No subsequent studies were conducted to investigate the risk of blood clot development as a result of Ortho Evra birth control patch use. The AP investigation was the first to attempt to update the risk findings. This report claims that the risk of developing a blood clot is three times greater in women taking Ortho Evra birth control patch, compared to women taking the pill. This means that the risk of a fatal blood clot from the Ortho Evra birth control patch is three in 200,000 compared to one in 200,000 for pill users, according to the AP report.

The report also blamed the Ortho Evra birth control patch for the deaths of dozens of young women who developed fatal blood clots while using the patch. Some experts state that no link has been established between Ortho Evra birth control patch and increased blood clot risks. Other experts are worried that the Ortho Evra birth control patch may pose additional risks to patients. With the pill, hormones are first processed through the digestive system, while hormones from the patch enter the blood stream directly. This may potentially increase the risk of blood clots and other fatal side effects from the Ortho Evra birth control patch.

"Ortho Evra Lawsuits Continue to Roll in"

The number of Ortho Evra lawsuits continues to rise as more and more women argue they suffered blood clot injuries after using the birth control patch. To date,...

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"J & J Wants to use Pre-emption for Immunity"

The maker of the Ortho Evra birth control patch is seeking legal protection from lawsuits over injuries caused by the product with argument...

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"FDA Approves Label Change for Ortho Evra"

The Food and Drug Administration approved a labeling change for the Ortho Evra birth control patch based on a new study linking the contraceptive to a greater risk of potentially fatal blood clots than the pill.

» Read More

FDA Ortho Evra Q&A - FDA revision to Ortho Evra label announced November 11, 2005

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