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FDA Approves Revised Label for Contraceptive Patch

In January, 2008, the U.S. Food and Drug Administration (FDA) approved changes to the labeling of the Ortho Evra Contraceptive Transdermal (Skin) Patch. The revised label will reflect new research demonstrating that women who use the patch are at an increased risk of developing serious and, in some cases, life-threatening blood clots in the veins. This condition is called venous thromboembolism (VTE).

VTE has two forms: deep-vein thrombosis (DVT) and pulmonary thromboembolism
(PE). DVT occurs when a clot forms deep in veins, usually in the lower extremities (legs or hip area), and is often associated with pain and swelling. If the clot breaks loose, it can move through the blood stream and eventually block the pulmonary artery, causing a PE. This can result in permanent damage to the lungs and sometimes death.

The Ortho Evra Contraceptive Transdermal Patch is manufactured by Ortho McNeil Pharmaceuticals, a division of Johnson and Johnson. The label changes are based on a study conducted by the Boston Collaborative Drug Surveillance Program (BCDSP) on behalf of Johnson and Johnson. The study included women 15-44 years old. According to the FDA, the results corroborated findings from two earlier studies concluding that women in this group were at a greater risk for VTE.

The prescription patch contains two hormones—ethinyl estradiol, an estrogen, and norelgestromin, a progestin—that are secreted through the skin into the blood stream. Since the patch exposes women to higher concentrations of estrogen than do pills, users are at higher risk of developing VTEs.

“For women that choose to use contraceptives, it is important that they thoroughly discuss with their health care providers the risks and benefits involved,” said Janet Woodcock, MD, the FDA’s deputy commissioner for scientific and medical programs, chief medical officer, and acting director of the Center for Drug Evaluation and Research.

Read the FDA release

Source: FDA news release dated January 18, 2008


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