ORTHO EVRA

Since July 18, 2005, investigative reports have linked Ortho Evra to dangerous blood clots. On Novermber 11, 2005, the Food and Drug Administration (FDA) announced that "women who use Ortho Ever are exposed to about 60 percent more extrogen than if they were taking a typical birth control pill". THis is important because increased estrogen translates into increased risks. According to the FDA, "estrogen use is linked to blood clots in the legs and lungs and other clotting problems such as strokes and heart attacks."

Ortho Evra is a combination transdermal contraceptive applied to the skin in the form of an adhesive patch. It was marketed as a convenient alternative to birth control pills. The hormones are imbedded in the patch's dhesive layer and are slowly released when the patch is applied to the skin. THe patch is applied once a week. It ws designed to stay on during bathing or exercise.

There is no epidemiologic data available to determine whether safety and efficacy with the transdermal route of administration would be different than with the oral route, such as with birth control pills. Ortho Evra, the first hormonal skin patch to be used for the prevention of pregnancy, was approved by the FDA on November 20, 2001.

Ortho Evra is considered a "combination hormonal contraceptive." The most common injuries associated with Ortho Evra have been blood clots, which can be life-threatening or fatal. In addition to or as a result of blood clots, women using combination hormonal contraceptives have been known to suffer from the following adverse:

  • Myocardial infarction (heart attack)
  • Thromboembolism and thrombotic disorders (thrombophlebitis, pulmonary embolism,cerebrovascular disorders, and retinal thrombosis)
  • Deep Vein Thrombosis (DVT)
  • Stroke, including Cereberal Hemorrhage and Cereberal Thrombosis
  • Hepatic neoplasia
  • Gallbladder disease
  • Death
Women who smoke are at greater risk of suffering from these dverse events. Medical conditions such as hypertension, high cholesterol, obesity and diabetes may also increase the risk these adverse events.