Pharmaceutical

New warnings, adverse reactions added to Ortho Evra

The Ortho Evra birth control patch has updated the CONTRAINDICTATIONS, WARNINGS and ADVERSE REACTIONS sections on its label and packaging, according to the Food and Drug Administration’s MedWatch July 2009 Drug Safety Labeling Changes posting. Ortho Evra was one of 38 drugs listed in the report.

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.