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Chrissie Cole
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FDA Approves Update to Ortho Evra Patch Label

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The U.S. Food and Drug Administration (FDA) has approved revisions to the current Ortho Evra Contraceptive Patch label.

The updated labels will reflect results from a new study that found users of the patch were at an increased risk of developing serious blood clots (also known as (VTE – venous thromboembolism), than those women who use birth control pills.

The study was conducted by Boston Collaborative Drug Surveillance Program (BCDSP) on behalf of Johnson & Johnson and included women between15-44.

“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, M.D., the FDA’s deputy commissioner for scientific and medical programs, chief medical officer, and acting director of the Center for Drug Evaluation and Research.

The FDA revised the label for Ortho Evra, in September 2006, to warn women of the risk of VTE based on two studies. One study, by i3 Ingenix, showed that some women using the patch were at a two-fold greater risk for developing VTE.

The other study, by BCDSP, showed they were not at an increased risk compared to women taking birth control pills that contain 30-35 micrograms of estrogen and progestin norgestimate.