Johnson & Johnson, which makes the Ortho Evra (norelgestromin/ethinyl estradiol) Transdermal System, has been the focus of hundreds of lawsuits filed over the past two years by women who suffered blood clots and other serious side effects from heightened estrogen levels caused by the birth control patches. Some reports include fatalities. J&J has already settled several of the lawsuits, and the company has told plaintiffs attorneys it is ready to settle remaining ones.

The new labeling on the Ortho Evra packaing includes
- CONTRAINDICATIONS – The term “significant hypertension” was replaced with actual blood pressure values.
- WARNINGS – Under “Elevated Blood Pressure,” providing more complete guidance to health care providers regarding use in women with hypertension.
- ADVERSE REACTIONS – Under “Clinical Trial Experience, Postmarketing Experience,” editorial revisions to provide for use of MedDRA terminology and a more user-friendly format.

The Ortho Evra patch was approved by the FDA in 2001. In 2008, J&J updated its labeling on the birth control patch after testing revealed women between the ages of 15 and 44 on the patch are at higher risk for pulmonary embolism. Serious side effects related to Ortho Evra include heart attack or stroke; blood clots in the legs, lungs (pulmonary embolism), or eyes, or in the deep veins of the legs; chest pain, breast cancer or cancer of the lining of the uterus, cervix or vagina; liver tumor (benign or cancerous); severe high blood pressure; and diabetes with complications of the kidneys, eyes, nerves or blood vessels.

SOURCE: Ortho Evra and Blood Clots › New warnings, adverse reactions added to Ortho Evra

However, students may want to weigh their contraception options more closely. Johnson & Johnson, the makers of the Ortho Evra contraceptive patch has been riddled with lawsuits claiming the patches cause serious side effects in young women, such as blood clots and even death. The patches reportedly can leak too much estrogen into the bloodstream causing the serious health problems.

According to reports, several lawsuits against the company have already ended with confidential settlements and Johnson & Johnson has already told plaintiffs attorneys that it is ready to work out settlements with the others it faces.

The Ortho Evra patch was originally marketed to women seeking an alternative to the once-daily birth control pill. However, since its debut there has been an emerging pattern of young women suffering from pulmonary embolisms and strokes.

Johnson & Johnson no longer actively markets the patch, but it is still available and has yet to be pulled from the market despite petitions by consumer group Public Citizen to the FDA to remove the product. The group also claims removal of the patch would have an environmental benefit, as the discarded patches could leak contaminants into the environment after they are disposed of by consumers.

SOURCE: Ortho Evra and Blood Clots › TCU students urged to heed contraception patch warnings