Ortho Evra®

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Orthoevra®

The Ortho Evra® birth control patch has become a popular birth control option for American women after receiving FDA approval in November 2001. Containing a combination of estrogen and progesterone that is slowly absorbed when applied to the skin, the patch allows the combined hormones to prevent ovulation and pregnancy. In less than three years on the market, Ortho Evra® was tried by more than five million women in the United States, which made the July 2005 Associated Press report that a dozen deaths during 2004 could be linked to the device's use so concerning.

According to the AP, about a dozen women, most of them in their late teens and early 20's, died from blood clots in 2004 that were using the Ortho Evra® patch. The AP filed a Freedom of Information Act to request to obtain reports of adverse events from the FDA, which they said revealed the risk of death with the patch could be about three times greater than with the pill. Ortho Evra®'s maker, Ortho-McNeil, refuted the AP's claims, saying the report exaggerated the risk by using too low a number of patch users in 2004.

The AP said there were 12 clot-related deaths among the approximately 800,000 Ortho Evra® users in 2004, but Ortho-McNeil said industry data showed two million women used Ortho Evra® in 2004. While the AP's review did not establish a casual link between the deaths and the patch, Amy Allina of the Washington-based National Women's Health Collective sent a letter to the FDA supporting the idea that the data provides a strong argument for a requirement by the FDA that the manufacturer of any new drug that is know to have serious side effects conduct a substantial post release study of its safety.

In the letter, Allina said that even if such a study did not establish causality between the deaths and Ortho Evra® use, women would have a clearer idea about the rate at which problems were occurring associated to the use of the patch. This information would allow women to make more informed choices about the use of hormonal contraceptives. The AP said an FDA medical reviewer recommended a post release study at the time Ortho Evra® was approved, but the FDA did not mandate the study.

Though some experts cautioned about overreaction to the AP report, others believed the adverse reports could be indicative of greater problems. Because Ortho Evra® is a new delivery system, the belief that the hormone dosage delivery is the same as those found in oral contraceptives could be inaccurate. Should a quicker dose deliver from Ortho Evra® be present, it could be making the drug more potent, thus increasing the risks for suffering adverse events.

Blood clots are a known risk of all hormonal contraception, but it is considered a rare event, especially among women under 35 years of age. The recent news stories regarding the risks of blood clots and strokes in women using Ortho Evra® have increased concerns. Ortho-McNeil has cautioned Ortho Evra® should not be used by women who have the typical risk factors for cardiovascular disease, such as smoking, a history of heart attack, stroke or clotting disorders.

For more information on your legal rights and options regarding Ortho Evra®, please contact us.