In 2002, the first contraceptive patch for women came on the market. This prescription drug, which is sold under the name "Ortho Evra," allows women to receive birth control medicine through a patch placed on their skin. One patch delivers its dosage over the course of a whole week, whereas birth control pills must be ingested daily. Since its introduction, over five million women have used the Ortho Evra patch.

FDA Warning

This past November, the FDA warned that women who use the patch are being exposed to levels of estrogen far higher than women who use birth control pills--as much as 60% more. Exposure to high levels of estrogen has been linked to an increased danger of blood clots, and information obtained from the FDA shows that women who use the Ortho Evra patch are three times more likely to develop blood clots than women who use birth control pills.

The FDA information also discloses that 23 of the women using the patch died, and as many as 17 of the deaths may have been related to blood clots. This is cause for concern, because the FDA itself estimates that it receives reports in only 1% to 10% of cases involving adverse drug reactions, and so the number of clot-related problems and deaths could very well be much higher.

For the time being, the FDA has approved of a change in the warning labels placed on the Ortho Evra patch, making users aware of the risk, but it has not pulled the drug from the market. The maker of Ortho Evra has vowed to launch its own study of the incidence of so-called "thrombotic injuries"--which include blood clots and strokes--associated with the use of the patch. However, there are reports that crucial data relating to thrombotic injuries from the original clinical trials was downplayed in the marketing campaign that was launched after the drug was approved.

Symptoms of blood clots are varied and can include sharp chest pain and coughing of blood (caused by clots in the lungs), pain in the calves (caused by clots in the legs), sudden loss of vision (caused by clots in the eye), or sudden and severe headaches, vomiting, dizziness, falling, and problems with speech and eyesight (a stroke, possibly caused by clots in the brain). Of course, if you use the Ortho Evra patch and have any of these symptoms, go to a hospital immediately. If you have used the Ortho Evra patch and have been treated for clotting, call us to discuss your legal options.

Remember, if you, or your loved one, have been a victim of a badly-designed product or drug, the lawyers at Dallas law firm Street and Ragsdale are here for you. It's always free to contact our lawyers.

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