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this pageOrtho Evra® Birth Control Patch May Increase Blood Clot Risk
A woman who uses the Ortho Evra® birth control patch increases her risk of developing blood clots in her legs and lungs. These blood clots can cause heart attacks or strokes.
Compared with women who use birth control pills, Ortho Evra® patch users have twice the risk of developing blood clots, according to a report released in February 2006, by Ortho–McNeil, the patch’s manufacturer. Also, patch users died from blood clots at three times the rate for pill users, an investigation by the Associated Press found.
How the Birth Control Patch Works
The patch works by releasing ethinyl estradiol (an estrogen hormone) and norelgestromin (a progestin hormone) through the skin directly into the blood stream. By contrast, the estrogen in birth control pills must be digested in the intestine before it enters the blood stream. The birth control patch delivers estrogen and progestin in a continuing manner as opposed to the rapid increases and decreases in these hormone levels produced by the pill.
Over 4 million women have used the Ortho Evra® patch for birth control since it was first approved in November 2001. Approval involved minimal testing. The safety and health information for the product was based on the effects of birth control pills, not on the effects of a product absorbed through the skin.
Patch Users Exposed to High Levels of Estrogen
Overall, patch users are exposed to 60% more estrogen than are women taking birth control pills that typically contain about 35 micrograms of estrogen (FDA News, November 11, 2005). At the request of the Food and Drug Administration, Ortho–McNeil added a bolded warning about high estrogen levels to the package insert for the Ortho Evra® patch.
However, the package warnings fail to adequately address any problems that may be caused by the patch’s progestin portion, norelgestromin, which is classified as a “third generation” or newer synthetic hormone. This hormone is different from the type of progestin used in some birth control pills. Progestin is normally an anti–clotting factor that counters the tendency of estrogen to cause clotting. However, third generation progestins such as the norelgestromin used in the patch may be less likely to achieve the required balance than older, more traditional progestins. Some studies have shown problems related to third generation progestins and blood clots (Am J Obstet Gynecol. 1999 Jun; 180 (6 Pt 2): S375–82; Br J Haematol. 1997 Apr; 97(1): 233–8; Mealey’s Litigation Report, Hormone Replacement Therapy, Vol 2, No. 6, January 2006).
Your Ortho Evra® Case
The Ortho Evra® patch is not a more effective birth control method than the birth control pill. “There is no medical reason for women to use the more dangerous Ortho Evra® rather than one of the older, better understood, and equally effective oral contraceptives,” comments the consumer group, Public Citizen (Press Release, November 11, 2005).
It appears that Ortho–McNeil attempted to solve a problem—the annoyance of having to take a daily pill—where none really existed. Their approach enabled the company to sell an expensive, risky product that is no more helpful than birth control methods that were already available.
Brayton Purcell is now evaluating cases of women who have been harmed by the Ortho Evra® birth control patch. Please feel free to contact us if you or a loved one was diagnosed with any of the following conditions while using the patch: heart attack, stroke, blood clots, pulmonary embolism, or deep vein thrombosis. We will evaluate your potential case free of charge, answer your questions, and inform you of your legal choices. We have been handling medically–related consumer cases for over 20 years and work hard to protect the legal rights of our clients.