Archive for December, 2007

Ortho Evra Birth Control Path

Saturday, December 15th, 2007

Ortho Evra is a contraception patch manufactured by Ortho-McNeil, a New Jersey subsidiary of Johnson & Johnson. When placed on your skin, this patch releases synthetic estrogen and progestin hormones to help prevent pregnancy. It can be applied to a woman’s upper outer arm, buttocks, abdomen or thigh. After seven days, the patch is removed and another is applied. This pattern is repeated three times then the patch is removed for seven days. It is believed that the patch is just as effective at preventing pregnancy as the oral contraceptive pills.

There are side effects with the Ortho Evra patch. In a clinical trial, 12% of the women suffered side effects from the patch including nausea and vomiting, a reaction on the skin the patch was placed one, breast discomfort, menstrual cramps, abdominal pain, and headache. However, some people believe that the patch is not safe and can cause a stroke, thrombosis (a blood clot), or pulmonary embolism.

All contraceptive methods that release estrogen list blood clots as a risk because estrogen promotes blood coagulation. However, users of the Ortho Evra patch may be more susceptible to a blood clot than users of other hormonal birth control methods. Some research suggests that users of the patch may be up to two or three times more likely to suffer from a serious or even fatal blood clot as those who take oral contraceptives.

In 2004, the Associated Press (AP) printed an article in which it said the Food and Drug Administration (FDA) received reports that patch users might be three times more susceptible to fatal events such as a blood clot as compared to oral contraceptive users. Out of the 800,000 women using the Ortho Evra patch in 2004, about a dozen, most of who were in their late teens or early 20s, died of blood clots that were believed to be related to the use of the Ortho Evra patch. Other users suffered strokes and other blood clot related problems that were not fatal.

Some doctors were shocked by the reports, but others said that some deaths are expected and that over four million women had safely used the patch. Those shocked by the report believe that the use of the patch should be further investigated and that the FDA knew there was a high chance of blood clots before the patch was approved.

After these reports, the warning label included with the Ortho Evra patch was revised to read “Most side effects of the Patch are not serious and those that are, occur infrequently. Serious risks, which can be life threatening, include blood clots, stroke and heart attacks and are increased if you smoke cigarettes.”

However, several lawsuits have been filed by the families of women using the patch who died from blood clots or other injuries. On September 2, 2005, a Georgia woman who suffered a pulmonary embolism filed a lawsuit in Federal Court in New Jersey. Another woman, a young mother who is paralyzed after suffering a stroke, also filed a lawsuit. In Wisconsin, the parents of a 14-year-old girl who died from a blood clot have filed a lawsuit, claiming the blood clot was due to the use of the patch. At least 23 lawsuits have been filed claiming that the use of the Ortho Evra patch resulted in death.

If you or someone you know has used the Ortho Evra patch and has suffered from blood clots, a heart attack, or a stroke, you should contact a lawyer about a possible lawsuit against the makers.