Ortho Evra® Birth Control Patch Increases Blood Clot Risk, New Package Insert Says
WASHINGTON, DC -- September 29, 2006 -- Women who use the birth control patch (Ortho Evra®) instead of the pill may increase their risk of developing serious blood clots, according to the revised package insert required by the Food and Drug Administration (FDA). The label change is based on the final results of a study that compared patients using the patch with patients who took typical birth control pills containing progestin and 35 micrograms of estrogen. The women who used the patch doubled their risk of blood clots in their lungs and legs compared with those who used the pill.
Another study did not find a difference in blood clot rates between birth control pill users and patch users. The FDA commented "Even though the results of the two studies are conflicting, the results of the second epidemiology study support FDA's concerns regarding the potential for Ortho Evra® use to increase the risk of blood clots in some women" (Questions and Answers, Ortho Evra, FDA, September 20, 2006). This view is more in line with an Associated Press (AP) investigation last July. The news service reviewed government reports and concluded that patch users died from blood clots at a rate that was much higher than that of women using birth control pills.
Both the patch and the typical birth control pill contain ethinyl estradiol (an estrogen hormone) and norelgestromin (a progestin hormone). The patch releases these hormones through the skin directly into the blood stream. Ortho Evra® users are exposed to about 60% more total estrogen in their blood than if they took birth control pills, according to the FDA. Excess estrogen exposure can increase the risk of blood clots. It has also been linked to heart attacks and strokes.
Ortho Evra® Lawsuits
The Ortho Evra® birth control patch is manufactured by Ortho-McNeil and Ortho Women's Health and Urology, which are owned by Johnson & Johnson. In a report to the Securities and Exchange Commission, Johnson & Johnson disclosed that 500 lawsuits have been filed against it involving Ortho Evra® injuries. Legal experts expect that more lawsuits will be filed against the company, which boasted $1.2 billion in contraceptive sales in 2005.
If you have used the birth control patch and developed blood clots or suffered a heart attack or stroke, please feel free to contact us at Brayton Purcell. We will evaluate your potential case free of charge, answer your questions, and inform you of your legal options. We have been handling medically-related consumer cases for over 20 years and work hard to protect the legal rights of our clients.
For more information about the birth control patch and estrogen, see the full text of the Ortho Evra® patch package insert. You will need to obtain a copy of Adobe Acrobat Reader to open this file. If you do not already have this software, you may download a free copy at the Adobe Acrobat web site.