Ortho Evra warnings alert women to the possible risks and dangers of using the Ortho Evra transdermal contraceptive patch (which is produced by Ortho-McNeil-Janssen Pharmaceuticals, a division of Johnson & Johnson). Ortho Evra warnings have come out over time and have become clearer and more serious, but the patch is still available, which allows it to continue to threaten the health of some women.
Regardless of the current Ortho Evra warnings, those who develop serious side effects as a result of using the Ortho Evra patch may have a legal claim against Johnson & Johnson – and they may be entitled to compensation for their injuries and losses.
Ortho Evra Label Change
In November 2005, the Food and Drug Administration (FDA) informed Johnson & Johnson that it would be updating the Ortho Evra warning label to include a “Black Box” warning. This warning informs women who use the Ortho Evra patch that they have a higher risk of developing serious side effects (particularly blood clots and blood clot-related complications). This is due to the fact that the patch delivers 60 percent more hormones to the body than other oral contraceptives.
The Ortho Evra black box warning indicates that the patch has the potential to cause life-threatening side effects. FDA black box warnings are the most serious type of FDA warnings, and they are one step before a full-blown product recall.
Ortho Evra Warning Label
Along with noting the increased risk of developing blood clots, the Ortho Evra warning label also states that women who are older than 35 years old, who smoke, or have a history of any of the following conditions should work with their doctors to find a safer form of birth control:
- Blood clots and/or deep vein thrombosis (DVT)
- Breast, uterine or cervical cancers
- Heart attack or heart disease
- Hepatitis or jaundice (during pregnancy or with the use of other contraceptives)
- Liver tumors
- Pulmonary embolism (PE)
- Severely high blood pressure
Ortho Evra FDA Warning
Currently, the FDA’s position on the Ortho Evra patch is that “Ortho Evra is a safe and effective method of contraception when used according to the labeling, which recommends that women with concerns or risk factors for serious blood clots talk with their health care provider about using Ortho Evra versus other contraceptive options.”
If you have been injured as a result of using the Ortho Evra patch or if you have lost a loved one to Ortho Evra side effects, the skilled defective drug lawyers at Chaffin Luhana LLP encourage you to attend a free initial consultation to learn more about your legal rights. Eric Chaffin and Roopal Luhana, the founding partners of Chaffin Luhana LLP have extensive experience litigating contraception lawsuits, and they are dedicated to helping their clients recover the maximum possible settlement for their injuries so they can focus on moving on with their lives.
If you or a loved one used the Ortho Evra patch and suffered from any side effect including DVT, gallbladder disease, stroke, pulmonary embolism, or heart attack you should contact us immediately for a free and confidential case review. You may be entitled to compensation and we can help.