Ortho Evra Birth Control Patch Raises Blood Clot Risks

By January 21, 2008Drug Safety

A study conducted by the Boston Collaborative Drug Surveillance Program confirms that the birth control patch Ortho Evra Contraceptive Transdermal (Skin) Patch increases the risk of developing serious blood clots.
Ortho Evra is a birth conrtrol patch manufactured by Johnson and Johnson, and has been linked to blood clots known as deep vein thrombosis or DVT’s, as well as pulmonary embolisms which if untreated can be fatal. On Jan. 18, the U.S. Food and Drug Administration approved changes to the drug’s label to include the results of the study.
Ortho Evra releases an estrogen hormone, ethinyl estradiol, and a progrestin hormone, norelgestromin, into the bloodstream through the skin. Because the body processes the hormones through the skin different than the hormones from birth control pills, women are exposed to about 60 percent more estrogen.
An earlier study conducted by i3 Ingenix, showed that women who use the patch were twice as likely to develop serious blood clots, also known as venous thromboembolisms (VTE), as women who take oral contraceptives. If the VTE travels to the lungs and triggers a pulmonary embolism, it can kill. The BCDSP study, which looked at women aged 15 to 44, supported the i3 Ingenix findings.
Ortho Evra is made by Ortho McNeil Pharmaceuticals, a Johnson and Johnson division. According to Bloomberg News, the company has been sued by more than 1,500 women who alleged they suffered strokes or blood clots in their lungs or legs after using the patch. Last October, Bloomberg News reported that the company agreed to pay $1.25 million to settle a suit filed by the family of a 14-year-old girl who died after she developed two blood clots in her lungs.
There’s more. Last fall, a New Jersey judge also made public a letter from a former Johnson & Johnson executive who alleged that the company improperly downplayed the risks associated with the Ortho Evra patch. The author of the letter said that he had investigated an “unusually high number” of blood clots and indicated that more than 20 deaths had been linked to the patch, according to an article in Bloomberg News.
A prescription drug that raises the risk of strokes and deadly blood clots is disturbing. The suggestion that the company misrepresented the risks of the patch to the public of a potentially fatal illness under most circumstance would be unbelievable. But with the examples of Vioxx, Bextra, Fen Phen, Baycol, Reszulin, Zyprexa and many more, drug companies ignoring or hiding risks in order to keep a block buster drug on the market to keep making profits instead of withdrawing the drug to keep patients safe appears to be the norm and not the exception. As a lawyer who practices in the area of pharmaceutical liability, I don’t find the fact that a drug company hid the fact that healthy young women were dying from strokes and blood clots after using the Ortho Evra patch surprising. If you took Ortho Evra and had a stroke or pulmonary embolism and would like more information regarding whether you have a case against Johnson and Johnson, please contact Jeffrey J. Lowe at 877-678-3400.