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Ortho Evra -- The Birth Control Patch

Ortho Evra, manufactured by Ortho-McNeil Pharmaceutical, Inc., is the first transdermal (skin) patch approved for birth control. Ortho Evra is a thin, beige patch that delivers continuous levels of the hormones norelgestromin and ethinyl estradiol (progrestin and estrogen, respectively) through the skin and into the bloodstream to prevent pregnancy.

Ortho Evra was approved by the U.S. Food and Drug Administration in November 2001 and first became available by prescription in April 2002.

Deaths Associated with Ortho Evra

Ortho Evra has recently been linked to the deaths of several women in the United States. In March 2004, Sasha Webber, a 25-year-old mother of two from Baychester, New York died of a heart attack after six weeks on the patch. In April 2004, 18-year-old Manhattan student Zakiya Kennedy collapsed and died in a New York subway station from a blood clot that had moved to her lung. The medical examiner concluded that her death was a side effect of the birth control patch. In November 2004, Kathleen Thoren, a 25-year-old mother in Texas died from a blood clot after using the patch for a few weeks.

The Associated Press recently obtained FDA records containing reports of adverse reactions associated with the patch. The Associated Press reported that within the collection of reports, 23 were death reports. Doctors who reviewed the 23 cases found about 17 that appeared to be clot-related, including 12 from 2004. [Source: Martha Mendoz, AP, "Deaths linked to patch", Cincinnati Enquirer, July 17, 2005]

New Warning Required for Ortho Evra

On November 10, 2005 the FDA announced that the Ortho Evra birth control patch can release up to 60% greater levels of estrogen than found in a birth control pill. The medical community has known for decades that high levels of estrogen can cause blood clots, leading to serious medical conditions such as deep vein thrombosis, pulmonary embolism, stroke, heart attack, and even death in young, healthy women. Because the product labeling for the Ortho Evra patch included claims that it was just as safe as a birth control pill, the FDA required Johnson & Johnson to add a warning in November 2005 about the increased risk of injury due to high levels of estrogen released from the Ortho Evra patch.

Although Ortho-McNeil's Ortho Evra birth control patch contains the same combination of ingredients as oral combination hormonal birth control products (estrogen and progestin), clinical trial data obtained from the FDA by the Associated Press suggests that women using the patch have a significantly increased risk of potentially fatal blood clot injuries (such as pulmonary embolism, stroke, and heart attack) over those using an oral contraceptive. The patch is touted as being more convenient than a daily pill, because it is only applied once per week, and only three weeks per month. Unlike the oral medication which is metabolized by the body's digestive system, the progestin and estrogen in the patch are delivered through the transdermal patch and released directly into the bloodstream. Dr. Pamela Berens of the University of Texas Medical School at Houston theorizes that "there may be something about the way the drug is metabolized that could increase the risk for clots."

If you have suffered any side effects, such as blood clots, pulmonary embolism, stroke, and/or heart attack, from your use of Ortho Evra, you may have a legal case. If you would like to speak with a lawyer, please use the Find Attorney button at the top of the page.

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