FDA Warns Ortho Evra Contraceptive Patch Users
Ortho Evra Contraceptive Patch News Alerts and Lawyer Updates

The Food and Drug Administration (FDA) announced on November 11, 2005 that the Ortho Evra contraceptive patch exposes millions of women who use the patch to levels of estrogen far higher than most daily birth control pills, putting them at higher risk for blood clots than previously disclosed. The FDA also approved updated labeling for the Ortho Evra contraceptive patch to warn healthcare providers and patients about the increased risk.

The warning from Johnson and Johnson subsidiary Ortho McNeil, makers of Ortho Evra patch, states that the patch exposes women to 60 percent more estrogen than daily birth control pills, which contain 35 micrograms. Ortho Evra is the first and only skin patch approved for birth control, and more than 4 million women have used the patch since it came on the market three years ago. The patch releases ethinyl estradiol, an estrogen hormone, and norelgestromin, a progestin hormone, through the skin into the bloodstream. It only needs to be changed once a week.

The Associated Press in July reported that, according to FDA records it obtained through a Freedom of Information Act, women using Ortho Evra in 2004 were three times as likely as women using birth control pills to die or develop nonfatal blood clots. The Associated Press learned that of the 23 cases in which death was the outcome, doctors reviewing the cases found 17 that appeared to be blood-clot-related, including 12 in 2004.

Since the FDA estimates that it receives reports of only between 1 percent and 10 percent of the serious adverse drug reactions that actually occur, the death rate for Ortho Evra may be significantly higher.

The Ortho-Evra patch, which is available by prescription only, has not yet been pulled off the market. The drug maker says it is launching its own study with input from the FDA to assess the dangers of using the patch. Women who may be using Ortho Evra should contact their physician if any of the following warning signals develop:

• Sharp chest pain, coughing of blood, or sudden shortness of breath (indicating a possible clot in the lung)

• Pain in the calf (indicating a possible clot in the leg)

• Crushing chest pain or tightness in the chest (indicating a possible heart attack)

• Sudden severe headache or vomiting, dizziness or fainting, disturbances of vision or speech, weakness, or numbness in an arm or leg (indicating a possible stroke)

• Sudden partial or complete loss of vision (indicating a possible clot in the eye)

• Breast lumps (indicating possible breast cancer or fibrocystic disease of the breast; ask your doctor or health care professional to show you how to examine your breasts)

• Severe pain or tenderness in the stomach area (indicating a possibly ruptured liver tumor)

• Severe problems with sleeping, weakness, lack of energy, fatigue, or change in mood (possibly indicating severe depression)

• Jaundice or a yellowing of the skin or eyeballs accompanied frequently by fever, fatigue, loss of appetite, dark colored urine, or light colored bowel movements (indicating possible liver problems)