The safety of the Ortho-Evra birth control patch has been questioned in the past few years after the Associated Press reported that research had surfaced about 23 deaths related to the patch. Doctors who reviewed the 23 cases of death found about 17 deaths that appeared to be clot-related, including 12 deaths from 2004. Roughly a dozen women, mostly in their teens and early twenties, died in 2004 from blood clots believed to be related to the birth control patch. Dozens more survived strokes and other blood clot related events.

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. While the estrogen level with the patch remains constant for one week until the patch is removed, the peak blood levels with a daily birth control pill rapidly declines to levels that are lower than on the Ortho-Evra.

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. Cigarette smoking increases the risk of serious adverse effects on the heart and blood vessels from the use of hormonal birth control methods. 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. * Current unexplained 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). * Current or suspected pregnancy. * Severe high blood pressure. * Diabetes with complications of the kidneys, eyes, nerves, or blood vessels. * An allergy to Ortho Evra or to any of its ingredients.

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