New warning OK'd for birth control patch

January 21, 2008

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

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