Monday, November 14, 2005

Bad News for the Ortho Evra Contraceptive Patch?

Ortho-McNeil (a subsidiary of Johnson & Johnson) has finally acknowledged the fact that women who use the Ortho Evra patch are at greater risk of developing blood clots, stroke, and death than woman who use other forms of oral contraceptives.

Women using the patch may receive 60% more estrogen than they would be exposed to if they were taking a birth control pill instead.

CBS News broadcasted a story from Austin, Texas, concerning documents produced in the course of a pending lawsuit involving a young mother who was paralyzed by a stroke only 12 days after she began using the patch.

The report noted that there were 4x as many strokes in women using the patch as in women using an oral contraceptive.

Ortho Evra, like the other hormonal contraceptives, has a black box warning about an increased risk of cardiovascular adverse reactions in older women who smoke. This type of warning is the strongest that the FDA can request.

In a pending case, an internal memo shows that the company in 2003 would not agree to pay for a study that compared its patch to its own Ortho-Cyclen pill because of concerns there was ‘too high a chance that study may not produce a positive result for Evra’ and there was a ‘risk that Ortho Evra may be the same or worse than Ortho-Cyclen.’”

Ortho Evra was approved by the Food and Drug Administration (FDA) in November 2001 and is the first contraceptive product to be approved as a skin patch. In 2004, the drug accounted for more than 9.9 million prescriptions with sales topping $411 million.

The abel warns that Ortho-Evra should not be used by those that have:

* A history of heart attack or stroke
* Blood clots in the legs (thrombophlebitis), lungs (pulmonary embolism), or eyes
* A history of blood clots in the deep veins of your legs
* Chest pain (angina pectoris)
* Known or suspected breast cancer or cancer of the lining of the uterus, cervix or vagina
* Unexplained vaginal bleeding (until your doctor reaches a diagnosis)
* Hepatitis or yellowing of the whites of your eyes or of the skin (jaundice) during pregnancy or during previous use of hormonal contraceptives such as ORTHO EVRA, NORPLANT [levonorgestrel], or the birth control pill
* Liver tumor (benign or cancerous)
* Known or suspected pregnancy
* Severe high blood pressure
* Diabetes with complications of the kidneys, eyes, nerves, or blood vessels
* Headaches with neurological symptoms
* Use of oral contraceptives (birth control pills)
* Disease of heart valves with complications
* Need for a prolonged period of bed rest following major surgery
* An allergic reaction to any of the components of Ortho Evra

More later.