Orth Evra

Orth Evra was the original birth control patch produced by Johnson & Johnson. The patch is applied to the skin on a weekly basis. The patch releases a flow of the estrogen hormone (ethinyl estradiol) and the progestin hormone (norelgestromin) directly through the skin into the blood stream. The major benefit of the patch over the pill is that it lessens the inconvenience and the chance of pregnancy resulting from a daily dosage.

Ortho Evra has been linked to side effects including blood clots related to deep vein thrombosis (DVT) and pulmonary embolism (PE). These side effects can lead to stroke, heart attacks, blood clots, and death.
High levels of estrogen have long been associated with causing blood clots in women. In November 15, 2005 the FDA labeling of Ortho Evra was updated its labeling to warn of the risk of pulmonary embolism brought about because it exposes women to higher levels of estrogen than birth control pills.


When the Food and Drug Administration approved the Ortho Evra Transdermal Birth Control Patch in November 2001, it became the first transdermal patch to effectively deliver a combination of norelgestromin and ethinyl estradiol, two vital hormones that help prevent unwanted pregnancy. The “patch” as it was called, was a revolution in birth control because it allegedly provided the same amount of security against accidental pregnancy in an easier to take format. One large advantage of the Ortho Evra patch, according to its manufacturer Ortho-McNeil, lies in the once weekly application to the skin on the thighs, hips, or upper body rather than a daily pill. The patch is replaced every week in a month except the fourth, which allows a woman to have a menstrual period as normal.

Unfortunately, the high concentrations of the norelgestromin and ethinyl estradiol hormones cause severe and even fatal side effects in some women. Birth control pills have been known to cause blood clots, heart attacks, and strokes in some women, and smoking is also known exacerbate these risks. While many experts believed that there would be similar risks in a transdermal patch, they did not expect the significant increase in fatalities caused by the Ortho Evra patch.

The first fatality linked to Ortho Evra was an 18 year old fashion student in New York who collapsed and died due to a blood clot that traveled into her lungs. This terrible incident was merely the first of many deaths of women of all ages due to the tragic side effects of Ortho Evra. The Associated Press published a report on July 17, 2005 that the chances of suffering a non-fatal blood clot with the birth control pill was approximately 1 and 3 in 10,000, while the risk of dying was 1 in 200,000. The rates for the Ortho Evra patch indicated that non-fatal blood clots occurred 12 out of 10,000 times, while the death rate from these blood clots was 3 out of 200,000. Doctors later confirmed that the Ortho Evra patch increased the likelihood of fatal cardiac-related events by 300%.

Between April 2002 and December 2004, Ortho-McNeil received over 500 reports of incidents related to side effects and cardiovascular problems because of the Ortho Evra Patch. In the same time period, manufacturers of traditional birth control pills received only 61 such complaints. Data also showed that women who used the patch suffered four times as many strokes compared to those who did not. Furthermore, the FDA believes that they only receive between 1 and 10% of the reports of serious reactions, so most experts believe that the fatality rate of the Ortho Evra patch could be even higher than estimated.


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