For more than two years now, the efficacy of the birth control patch, Ortho-Evra, has been in question after research indicated 23 deaths related to the patch. About 17 of those deaths appeared to be blood clot related. Dozens more women in their teens and twenties suffered strokes and other blood clot related events.
Due to the many adverse side effects associated with Ortho-Evra, the Food and Drug Administration (FDA) ordered that changes be made to the patch’s label. In November 2005, a new warning stated that women who use the patch are exposed to approximately 60% more total estrogen in their blood than if they were taking a birth control pill containing about 35 micrograms of estrogen. Because the patch had been marketed with claims stating that it was just as safe as the pill, the FDA required the manufacturer, Ortho McNeil Pharmaceuticals, to add another warning about the increased risk of injury due to high levels of estrogen released from the patch.
Smoking cigarettes while wearing the patch increases the risk of serious adverse effects on the heart and blood vessels. This risk increases with age. Simply put, women who take hormonal birth control medication should not smoke.
Ortho-Evra should not be taken by women with a history of:
- High blood pressure
- Heart attack or stroke
- Blood clots in the legs, lungs, or eyes
- Diabetes with complications
- Chest pain
- Vaginal bleeding