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Ortho Evra, manufactured by Ortho-McNeil Pharmaceuticals, Inc. is the first hormonal skin birth control patch to be used for the prevention of pregnancy. It was approved by the FDA in November 2001.
Ortho Evra is a 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 embedded in the patch’s adhesive layer and are slowly released when the patch is applied to the skin. The patch is applied once a week, and it was designed to stay on during bathing or exercise.
Deadly Side Effects
For more than two years now, the efficacy of the birth control patch 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.
Ortho Evra is considered a “combination hormonal contraceptive,” and the most common injuries associated with the patch have been blood clots, which can be life-threatening. In addition to the potentially-fatal blood clots, women using the patch have been known to suffer:
- Heart attack
- Thromboembolism and thrombotic disorders
- Deep vein thrombosis (DVT)
- Gallbladder disease
- Hepatic neoplasia
Due to the many adverse side effects associated with Ortho-Evra, the 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. Because the patch had been marketed with claims stating that it was just as safe as the pill, the FDA required the manufacturer to add another warning about the increased risk of injury due to the 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.
In addition to smokers, 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
- Blood clots
- Vaginal bleeding
If you think you or a loved one may have suffered an injury or damages (including a blood clot, stroke or heart attack) as a result of using the Ortho Evra contraceptive patch, you owe it to yourself to speak to an experienced drug or pharmaceutical injury attorney about the possibility of investigating the claim and bringing a lawsuit to recover for your damages and injuries. Call Colling Gilbert Wright & Carter at (855) 880-4741 or complete our online form to arrange a free case review in Orlando, Florida.