A woman who uses the Ortho Evra Contraceptive Transdermal Patch runs a higher risk of developing VTE (venous thromboembolism) – serious blood clots – compared to a woman who does not use the patch, prompting the Food and Drug Administration (FDA) to approve additional changes to the patch’s label. The FDA informs that VTE can lead to pulmonary embolism.

A study carried out by the Boston Collaborative Drug Surveillance Program (BCDSP) for Johnson & Johnson on women aged 15-44 support a previous study which found that women using the patch ran a higher risk of VTE. The FDA labeling decision is based on the BCDSP study.

Janet Woodcock, M.D., Deputy Commissioner for Scientific and Medical Programs, Chief Medical Officer, and acting director of the Center for Drug Evaluation and Research, said “For women that choose to use contraceptives, it is important that they thoroughly discuss with their health care providers the risks and benefits involved. This is an example of FDA working in tandem with the drug manufacturer to keep the public informed of new safety data and epidemiological studies that may impact health decisions about the use of FDA approved products.”

In September 2006 the FDA revised the label, warning users of the VTE risk, based on two studies. One study, carried out by i3 Ingenix, demonstrated that some patch users ran double the risk of developing VTE. The second study, carried out by BCDSP, found that users did not have a higher VTE risk compared to women who used birth control pills containing 30-35 micrograms of estrogen and the progestin norgestimate.

The Ortho Evra Transdermal Patch releases an estrogen hormone (ethinyl estradiol) plus a progestin hormone (norelgestromin) into the blood stream through the skin. The human body processes the hormones differently from hormones from the birth control drug. Because of this women who use this form of birth control are exposed to 60% more estrogen, compared to those who use typical birth control pills that contain 35 micrograms of estrogen. One of the side effects of elevated estrogen levels is a higher risk of developing VTE.

The FDA advises women to discuss this higher VTE risk linked to the Ortho Evra Transdermal Patch with their health care provider. The birth control pill is taken daily, while the patch is applied once a week.

The FDA stresses that when used according to the labeling. the patch is a safe and effective method of contraception. The labeling says that women with concerns or risk factors for serious blood clots should talk with their health care provider about using the patch versus other contraceptive options.

Ortho Evra (norelgestromin/ethinyl estradiol) Information

What is venous thromboembolism (also called thrombophlebitis)?

This is a term used to describe a blood clot in a vein. It often becomes painful, red and swollen. This clot might partially or totally block the flow of blood. VTE most commonly occurs in the veins of the legs and pelvis, and also the arms.

If the blood clot, or part of it, breaks off and travels to the lungs/heart it is called a pulmonary embolism.

Apart from the cause mentioned in this article, VTE can also be triggered by prolonged bed rest, prolonged period of inactivity, a very long car/plan trip, recent surgery, a recent major illness, obesity, an injury to one of the limbs, and pregnancy. Some people with inherited blood disorders may be at higher risk of developing VTE, as well as cancer patients and smokers.

Written by – Christian Nordqvist