WASHINGTON, Jan 21, 2008 (UPI via COMTEX) -- 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.
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Copyright 2008 by United Press International