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Ortho Evra Needs to Go, Public Citizen Says

May 8, 2008 | Parker Waichman Alonso LLP

A prominent consumer advocacy group says Ortho Evra, Johnson & Johnson's controversial birth control patch, is too dangerous to be on the market.  Public Citizen is asking federal regulators to ban Ortho Evra because it poses a higher risk of potentially fatal blood clots than other hormone-based contraceptives.  

When Ortho Evra was introduced in 2002, Johnson & Johnson touted the once-weekly patch as a convenient alternative to daily oral contraceptive pills. The drug’s original safety label stated that the patch’s health risks were similar to those of oral contraceptives. But in 2005, the Food & Drug Administration (FDA) warned that women using Ortho Evra were exposed to approximately 60 percent more estrogen than those who use oral contraceptive pills. It is believed that the difference in exposure is related to the delivery mechanism of the birth control patch. Hormones in birth control pills are partially diluted by the digestive system. However, hormones in Ortho Evra are absorbed directly into the blood stream, which causes a higher concentration of the medication to enter a patient’s body. High levels of estrogen can greatly increase the risk of developing blood clots, heart attacks, strokes and other serious injuries.

As of November 2005, the FDA had received twenty-one reports of life-threatening blood clots and other ailments associated with the use of Ortho Evra. Then in 2006, a study was published that showed women using Ortho Evra were twice as likely to suffer a type of blood clot called venous thromboembolisms (VTEs) — a clot that can travel to the lungs and cause a fatal pulmonary embolism - as those taking oral birth control pills. That study prompted the FDA to request a change on the Ortho Evra label to include a stronger safety warning. Just this past January, the FDA asked that the Ortho Evra label be changed again to include information on yet another study that indicated the patch doubles the risk of developing VTEs compared to the Pill

Public Citizen's Health Research Group filed a petition with the FDA today asking that Ortho Evra be removed from the market.  The petition said the amount of estrogen released from the Ortho Evra patch varies widely among individual women. "The considerable safety concern of high-dose, variable estrogen exposure tips the balance of risks and benefits against the availability of Ortho Evra as a contraceptive," wrote Sidney Wolfe, head of the research group.

Since 2006, Ortho Evra has been named in well over 2000 lawsuits. As those Ortho Evra lawsuits have made their way through the courts, evidence has been presented that Johnson & Johnson knew long before the FDA or the public that the patch put users at risk for developing blood clots. In Ohio, lawyers have filed papers detailing two separate Ortho Evra studies that showed the patch was dangerous, but where altered or suppressed by Johnson & Johnson. In August, the New Jersey Supreme Court released a letter written to Johnson & Johnson CEO William Weldon in 2005 by an unnamed former vice president stating that he or she had resigned from the company because of its decision to downplay safety concerns regarding Ortho Evra. Joe Lippman, another former Johnson & Johnson employee who was fired in 2006, has testified that in the late 1990s, he raised concerns over “dangerously high levels of estrogen” that users of the patch were exposed to, but was ignored.