Ortho Evra Patch
Ortho Evra Side Effects
Millions of women using the Ortho Evra birth control patch have been exposed to high doses of hormones and may be at risk for pulmonary embolisms, blood clots, heart attacks and other serious side effects.
In July 2005, the media revealed that the risk of dying or suffering a survivable blood clot while using the Ortho Evra birth control patch was three times higher than when using birth control pills. The Ortho Evra birth control patch deposits estrogen directly into the bloodstream. Since the method of administration is not in the same manner as birth control pills, the amount of estrogen deposited in significantly higher. There is a well-established connection between estrogen and side effects like blood clots, stroke, and heart attack. Increased estrogen exposure may increase the risk of these birth control patch side effects. Until recently, however, users of Ortho Evra were not warned that they could be at higher risk for these serious side effects or death.
Was Ortho McNeil aware of the greater risk of side effects with the Ortho Evra Patch?
In November 2005, the Food and Drug Administration (FDA) reported that the Ortho Evra birth control patch would carry a new label warning users they will be exposed to 60% more estrogen than users of the typical birth control pill. This announcement came four months after the Associated Press reported that the risk of dying or suffering a survivable blood clot was three times higher for birth control patch users than pill users.
The announcement that the birth control patch delivers more than twice as much estrogen as the pill probably came as a surprise to many patch users, since early reports talked about the similarities between the patch and the pill but did not mention this significant difference. The FDA approved the Ortho Evra patch, touted as a more convenient way to get the same birth control effect as with the pill, in 2001. At that time, it was stated that Ortho Evra was as safe as the pill and carried only the same risks as the pill.
Health Risks Associated with the Ortho Evra Patch
Ortho Evra is a birth control patch that delivers the hormones estrogen and progestin through the skin in order to prevent ovulation. These are the same hormones used in other types of contraception, including the birth control pill, so many of the risks associated with this type of contraception are well established. Estrogen is a drug that promotes blood coagulation so it is known that blood clot and blockage are a serious risk related to the drug. Since users of the patch are exposed to more than twice as much estrogen as pill users, there is some concern that they are at greater risk for all estrogen related problems.
Warning Signs of Serious Ortho Evra Related Health Problems
Twenty-year-old student, Amanda Bianchi, did not know what was wrong when she starting getting severe headaches. She went to the emergency room almost daily for two weeks. After three weeks in critical care, a 6 to 8 inch blood clot was found in her brain. Doctors suspected the clot was associated with the use of the Ortho Evra birth control patch.
Some of the most serious and potentially deadly risks related to Ortho Evra are related to the drug estrogen, which has the effect of promoting blood coagulation. As a result, there is a high risk of blood clots. Blood clots generally begin in the leg and can be extremely dangerous if they travel to the heart, lung, or brain. Stroke, heart attack, or death may result. Although a problem may present itself in many different ways, there are some critical signs that a woman should watch for. Dangers of Ortho Evra Exposed by Media
An analysis of data from federal drug safety reports showed that in 2004, when 800,000 women were using the patch, the risk of dying or suffering a survivable blood clot was three times higher for women using the patch than women using birth control pills. The Associated Press (AP) obtained this information through the Freedom of Information Act. What the data suggests is that the patch may not pose the same risks as the birth control pill that contains the same hormones. This came as a surprise to many, since the birth control patch had been considered a comparable but more convenient alternative to the pill. When the patch was approved by the Food and Drug Administration (FDA) in 2001, it was reported that the patch was as safe and as effective as the oral contraceptives and was associated with similar risks.
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