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Mom Wants Ortho Evra Off The Market Following Daughter’s Death

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The mother of an Ortho Evra birth control patch user is calling for the drug to be removed from the market, following her daughter’s sudden death from a pulmonary embolism.

Adrianna Niedner, 17,  had just begun her freshman year at Trinity College when she collapsed in her dorm room.  According to the Boston Globe, Leslie Niedner began to suspect that Ortho Evra played a role in her daughter’s death when someone asked if Adrianna had used it.  An internet search quickly revealed dozens of similar stories.  Leslie is now convinced that Ortho Evra caused the blood clot that killed her daughter. 

Thousands of Ortho Evra users have  filed lawsuits against Johnson & Johnson for injuries, including blood clots, heart attacks and strokes,  they claim were the result of the patch.  At least 20 of the women named in the lawsuits died after using it.  According to the Boston Globe, two whistleblowers have also come forward to say Johnson & Johnson was downplaying its risks. Last October, we reported that the drug maker had spent just over $68 million to settle hundreds of lawsuit.

Leslie is among the many who have sued Johnson & Johnson over Ortho Evra, but according to the Boston Globe, she appears unwilling to accept a settlement.  Leslie wants to take Johnson & Johnson to court.

What Leslie most  wants, however,  is to have Ortho  Evra  removed from the market.  Sidney Wolfe, the director of the Health Research Group at the consumer advocacy group, Public Citizen, agrees  with her, and calls the patch “needlessly dangerous.”

When Ortho Evra was introduced in 2002, Johnson & Johnson touted it as a convenient alternative to daily oral contraceptive pills, and its 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. 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.

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. In January 2008, the FDA asked that the Ortho Evra label be changed yet again to include information on another study that indicated the patch doubles the risk of developing VTEs compared to the Pill.

Though sales of Ortho Evra have dropped 75 percent since its dangerous side effects were publicized, at least 2 million women are still using the patch.

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