In November 2005, The Food and Drug Administration approved a new warning label for Ortho Evra, stating in bold letters that the patch exposes women to about 60 percent more estrogen than the birth control pill. The makers of Ortho Evra, Ortho-McNeil, previously failed to warn users of the higher estrogen levels, which may increase the risk of heart attack, stroke, pulmonary embolism, deep vein thrombosis and death.

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. 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.

However, in July 2005 the Associated Press 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)

Younce & Vtipil is devoted to assisting people who have suffered serious Ortho Evra side effects. If you or a loved one has experienced a heart attack, stroke, or serious clot while using the Ortho Evra patch, you may want to consider your potential legal claim for this loss.

At Younce & Vtipil, it will cost you nothing to speak with an attorney about your potential claim and there is no obligation when you call. We are typically paid on a contingent fee basis, meaning that we are not paid until we successfully obtain money for our client. If we can be of service to you, your family or friends, please do not hesitate to call us at 1-800-811-9495 or contact us online.