Within the past several years, reports have surfaced about the dangers of the Ortho Evra birth control patch. Physicians are finding an increased risk of blood clot and blood clot related conditions among many women in their teens and twenties. Additionally, physicians have noted that of the 23 deaths linked to the patch, 17 were blood-clot related.

Due to the startling and serious adverse side effects associated with the use of Ortho-Evra, the FDA addressed the issue and requested changes be made to the birth control's label in order to reflect the newfound knowledge. In November 2005, a new label was created. The new bolded warning specifically states that women who use Ortho Evra are exposed to approximately 60 percent more total estrogen in their blood than if they were taking a typical birth control pill containing 35 micrograms of estrogen. However, the maximal blood level of estrogen (peak blood levels) is about 25% lower with Ortho-Evra than with typical birth control pills. On a daily birth control pill, estrogen levels decline to levels lower than the Ortho Evra patch, in which estrogen levels remain constant until the patch is removed for the off week.

Additionally, because the product labeling for the Ortho-Evra patch included claims that it was just as safe as "the pill," the FDA required Johnson and Johnson add a warning in November 2005 about the increased risk of injury due to high levels of estrogenreleased from the Ortho Evra patch.

As with traditional oral contraceptives, women who smoke should not take Ortho-Evra. The use of hormonal birth control methods affects the heart and blood vessels adversely when an individual smokes. This risk increases with age and with heavy smoking (15 or more cigarettes per day) and is quite marked in women over 35 years of age. It is recommended that women who use hormonal birth control methods should not smoke.

Ortho Evra should not be used by women who have a history of:

* Heart attack or stroke.

* Blood clots in the legs, lungs (pulmonary embolism), or eyes.

* Blood clots in the deep veins of the legs.

* Chest pain.

* Known or suspected breast cancer or cancer of the lining of the uterus, cervix or vagina.

* Consistent and unexplainable vaginal bleeding.

* Yellowing of the whites of the eyes or of the skin (jaundice) during pregnancy or during previous use of hormonal contraceptives.

* Liver tumor (benign or cancerous).

* If an individual is pregnant or becomes pregnant.

* Severe high blood pressure.

* Diabetes with complications of the kidneys, eyes, nerves, or blood vessels.

* Signs of an allergic reaction to the patch's ingredients or the patch itself.

Along with the FDA is the Ortho-McNeil Pharmaceuticals Inc., continues to monitor the use and side effects of Ortho-Evra.