Ortho Evra Birth Control Patch
In January 2008, the FDA issued a requirement to change the Ortho Evra label following the release of a highly negative study conducted by the Boston Collaborative Drug Surveillance Program. The study, evaluating Ortho Evra users between the ages of 15 and 44, found a higher risk of blood clotting with Ortho Evra than with the birth control pill. The January 2008 update alerts women to the increased risk associated with Ortho Evra and advises those at higher risk of blood clots to consider alternative contraceptive measures.
How Ortho the Evra Patch Works
The Ortho Evra birth control patch is a transdermal (absorbed through the skin) alternative to “the pill” and other traditional birth control methods. This once-a-week treatment delivers a continuous flow of progestin and estrogen to help prevent pregnancy.
Ortho Evra was the first contraceptive patch to be approved by the FDA. Developed and marketed by Ortho-McNeil, a subsidiary of Johnson & Johnson, the patch exposes women to 60 percent more estrogen than an oral contraceptive. When levels of estrogen in the bloodstream are elevated, the risk of health complications (notably blood clotting) is higher.
Ortho Evra Blood Clot Warning
Ortho Evra has come under increased scrutiny following reports linking the birth control patch to the development of blood clots (venous thrombosis). Contraceptives contain high levels of estrogen and other hormones that prevent pregnancy.
Estrogen, the primary female sex hormone, plays an important role in regulating the menstrual cycle. It also has a number of other functions, including the promotion of coagulation, or blood clotting. Coagulation is a natural body function that prevents profuse bleeding. However, increased estrogen levels can cause abnormal coagulation in the legs and lungs, leading to an artery blockage that can inhibit blood flow (embolism); this, in turn, can lead to a stroke.
Ortho Evra Label Change
Reports of Ortho Evra users experiencing blood clots led to further FDA regulation of the patch. In 2005, the FDA approved an Ortho Evra label change that specifically warned women about the risks associated with higher levels of estrogen.
Despite the reports of abnormal blood clotting with Ortho Evra, there was no definitive link between the two. The FDA continued to monitor the safety of the patch while Ortho-McNeil conducted additional tests comparing Ortho Evra with alternative contraceptive measures.
Women using the Ortho Evra patch are advised to consult with their healthcare provider to determine an appropriate course of action.
Ortho Evra Lawsuits
A number of Ortho Evra lawsuits have been filed on behalf of women injured as a result of using the birth control patch. If you or a loved one has experienced an Ortho Evra injury, you may be entitled to receive compensation for your pain and suffering.
The lawyers of Levin, Simes, Kaiser & Gornick are experienced personal injury attorneys. To learn more about your rights as an Ortho Evra injury victim and determine your eligibility for compensation, contact the law offices of Levin, Simes, Kaiser & Gornick at (800) 901 4001.
Levin Simes Kaiser & Gornick, LLP
44 Montgomery Street, 36th floor
San Francisco, CA 94104
Ph: 1.800.901.4001
Fax: 415.981.1270
