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FDA Turns Blind Eye to Ortho Evra, Even Though it is the 'Most Dangerous Contraceptive on the Market'

Jan 21, 2008 | Parker Waichman Alonso LLP

The Ortho Evra Birth Control Patch is still being called a “safe and effective” contraceptive by the Food & Drug Administration (FDA), even though two separate studies have now shown that Ortho Evra users are at a higher risk of developing potentially fatal blood clots than women who use oral birth control pills.  This weekend, even as the FDA announced it was adding a second blood clot warning to the Ortho Evra label, patch users were not advised to seek other forms of birth control.  Instead, users of the Ortho Evra were told  by the FDA to  “thoroughly discuss with their health care providers the risks and benefits involved. ”

Johnson & Johnson received FDA approval to market the Ortho Evra Birth Control patch in 2001.  When it went on the market in 2002, the company touted Ortho Evra as a more convenient alternative to once-daily birth control pills.  Johnson & Johnson maintained that Ortho Evra carried side effects similar to the Pill, and exposed users to similar amounts of estrogen.

But that assertion was not true.  Because the estrogen in Ortho Evra is absorbed through the skin, users are actually exposed to much more.  In 2005, the 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. 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.

On Friday, the FDA added yet another warning to the Ortho Evra label after a second study confirmed the findings of the 2006 research.  The latest research, from an epidemiological study conducted by the Boston Collaborative Drug Surveillance Program on behalf of Johnson & Johnson, again shows that the patch doubles the risk of developing VTEs compared to the Pill. But despite this confirmation of its high blood clot risk, the FDA does not appear willing to remove Ortho Evra from the market, nor has it announced any further Ortho Evra safety reviews.   And shockingly, the FDA press release announcing the latest Ortho Evra labeling changes continues to refer to the patch as a safe contraceptive.  According to the FDA, choosing to use Ortho Evra is a simple matter of a woman conducting the equivalent of a risk/benefit analysis with her doctor.

Not surprisingly, the FDA’s conduct in regards to Ortho Evra is not setting well with critics, who would like to see the patch pulled from the market all together.  “This is crazy. Risk/Benefit ratio?  Compared to what?” asked Jerrold Parker, a partner in the law firm Parker Waichman Alonso, LLP, which is representing many Ortho Evra plaintiffs.  “It is the most dangerous contraceptive on the market! Why should anyone take the greatly enhanced risk?”