New warning OK'd for birth control patch

The U.S. Food and Drug Administration has approved a warning for the Ortho Evra Contraceptive Transdermal Patch label concerning the risk of blood clots.

The new label will include a warning that users of the birth control patch are at higher risk of pulmonary embolism from blood clots known as venous thromboembolism than women using birth control pills.

"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 Dr. Janet Woodcock, the FDA's deputy commissioner for scientific and medical programs. "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."

The FDA said it believes Ortho Evra is a safe and effective method of contraception when used according to the labeling, which recommends women with concerns or risk factors for serious blood clots talk with their healthcare provider about using Ortho Evra versus other contraceptive options.

The Ortho Evra Contraceptive Transdermal Patch is manufactured by Johnson and Johnson.

Copyright 2008 by United Press International


Explore further

FDA revisits safety of newer birth control drugs

Citation: New warning OK'd for birth control patch (2008, January 21) retrieved 19 January 2020 from https://medicalxpress.com/news/2008-01-okd-birth-patch.html
This document is subject to copyright. Apart from any fair dealing for the purpose of private study or research, no part may be reproduced without the written permission. The content is provided for information purposes only.
 shares

Feedback to editors

User comments