Since the approval of the Ortho Evra® patch in 2001, 4 million women have used it as an alternative to conventional birth control, the Pill. According to reports received by the Associated Press, in 2004 approximately 12 women died as a result of using the Ortho Evra® patch. In investigating these fatalities, the Food and Drug Administration (FDA) noticed that blood clots caused by the patch were three times higher than those caused by the Pill.

The Ortho Evra® patch works by releasing two hormones, ethinyl estradial (estrogen) and norelgestromin (progestin) through the skin to be absorbed directly into the blood stream. This process is very different from that of the Pill. The Pill has to be digested in the intestines before it can enter the blood stream. The patch is also different from the Pill in that it is applied to the skin weekly; therefore, missing does is drastically decreased. Even though missing doses—as a person might if they were taking the Pill— is generally not an issue for those using the patch, the amount of hormones that enter the bloodstream, particularly estrogen, may be causing the dangerous blood clots.

On Nov. 10, 2005, the FDA approved updated labeling for the Ortho Evra® patch to warn patients and healthcare providers of the risks associated with using the contraceptive. In this new labeling, the FDA warns that those women who use the patch are exposed to 60 percent more estrogen in their blood; the Pill's estrogen levels once in the blood stream are lower than estrogen levels by caused by the patch. The FDA strongly advises women to discuss with their healthcare providers the risks of using the patch, and possibly even switching from the patch to the Pill. However, it is not recommended that women cut or alter the patch in anyway, as it could render the patch ineffective.  Also women who smoke are not advised to use the patch because it increases the risk of heart problems.

In addition to the increased risk of blood clots, the Ortho Evra® patch may produce other side effects that are uncomfortable but not fatal. They include nausea, breast tenderness, headache, and cramps. These symptoms are similar to those associated with the Pill; however, using the Pill is safer because the risk of developing blood clots is lower. 

The death rate for the patch is three times the rate of the Pill. It is clear that using the Ortho Evra® patch is risky and there is no evidence that proves the patch is more effective than conventional contraceptive pills. Even though there is the convenience associated with using the patch in that it is applied to the skin weekly and there is no risk of forgetting a dose as there is in taking the Pill. However, the risk of blood clots and death is much higher. If you feel you have been injured by using the Ortho Evra® patch, see your physician immediately and if necessary, seek legal counsel.

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