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Link Of Ortho Evra Patch And Death
Ortho Evra is a rather new form of birth control that is available for women to use as a patch on their skin. However, reports are beginning to surface about the risks of the Ortho Evra patch that may have been responsible for at least 23 deaths due to the increase risk of developing blood clots within the body.
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. A new label was developed in November 2005. 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. 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.
* The clots can form in the eyes, legs or lungs, which is known as pulmonary embolism.
* 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.
* An allergy to Ortho Evra or to any of its ingredients.
Along with the FDA is the Ortho-McNeil Pharmaceuticals Inc., continues to monitor the use and side effects of Ortho-Evra.