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Jan 18, 2008 4:44 pm US/Central
FDA Adds Warning Label To Birth Control Patch
WASHINGTON (AP) ―
A new study showing an increased risk of blood clots among women using a contraceptive skin patch prompted the Food and Drug Administration on Friday to add that finding to thedrug's label.
The agency said the label on the Ortho Evra Contraceptive Transdermal Patch will include the results of a study in women aged 15-to-44 indicating a higher risk of clots than for women using birth control pills.
The blood clots could potentially lead to a lung embolism, the agency said.
"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.
The agency said it believes the patch is a safe and effective method of contraception, but recommends that women with concerns or risk factors for serious blood clots talk with their health care provider about contraceptive options.
The possibility of blood clots was first placed on the Ortho Evra label in September 2006.
Ortho Evra is a prescription patch that releases hormones through the skin into the blood stream. Because the hormones are processed by the body differently than hormones from birth control pills, women using the product will be exposed to about 60 percent more estrogen than if they were using typical birth control pills, FDA said.
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