Ortho Evra® Patch May Increase Blood Clot Risks
Birth Control Patch Exposes Women to Risky Levels of Estrogen
WASHINGTON, DC — November 18, 2005 — Ortho Evra®, the skin patch used for birth control, can expose women to 60% more estrogen than most contraceptive pills, according to a warning issued by the Food and Drug Administration (FDA) (FDA News, November 11, 2005). This excess estrogen may increase the risk of blood clots, strokes and heart attacks.
About a dozen otherwise healthy young women using the Ortho Evra® patch died in 2004 from blood clots, according to reports obtained by the Associated Press (AP) in July of this year. Before the patch was approved, the FDA noticed non–fatal blood clots from the patch were three times higher than those from contraceptive pills, the news wire service said. After the patch came on the market, deaths from use of the patch also were three times the rate of those for contraceptive pills, according to the AP.
New Warning About Blood Clots
Ortho McNeil, the manufacturer of the Ortho Evra® patch, added a new bolded warning to the drug’s package insert this month at the request of the FDA. The insert specifically states that a woman who uses Ortho Evra® is exposed to about 60 percent more total estrogen in her blood than if she were taking a typical birth control pill on a daily basis containing 35 micrograms of estrogen. She is more likely to develop blood clots, which may lead to heart attacks.
The prescribing instructions also state that female smokers who take estrogen are particularly susceptible to heart problems. Heart attack risk from the patch increases with age and with “heavy smoking,” defined as 15 or more cigarettes per day. Women who use the Ortho Evra® patch should not smoke, the instructions add.
The FDA advises women to talk to their doctors if they wish to switch from the Ortho Evra® patch to birth control pills. Women are urged not to cut the patch in an attempt to receive lower estrogen doses. If the patch is cut or altered, it may not protect the patient against pregnancy.
How the Ortho Evra® Patch Works
More than 4 million women have used the Ortho Evra® patch since the FDA approved it in November, 2001. The patch releases 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. This difference may account for the contrast in estrogen levels in patients who use the patch as compared to those who take birth control pills.
Besides increasing the risk of blood clots, the Ortho Evra® patch may produce these side effects:
- breast tenderness
- headache
- nausea
- menstrual changes
- stomach cramps and bloating
Birth control pill users may also experience the additional side effects listed above, although their risk of developing blood clots is lower. There is no evidence that the Ortho Evra® patch is a more effective birth control method than the birth control pill, according to the consumer group, Public Citizen (Press Release, November 11, 2005). The group first alerted the public to the link between blood clots and Ortho Evra® over two months ago. More recently, it concluded: “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.”
Brayton Purcell is concerned about unsafe drugs, including the Ortho Evra® patch. If you have been injured by this product, or by another harmful drug, please feel free to contact us. 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.
