Monday, January 21, 2008

New Precaution for Contraceptive

WASHINGTON (AP) — A new study showing an increased risk of blood clots among women using a contraceptive skin patch has prompted the Food and Drug Administration to add that finding to the drug’s label.

The agency said on Friday that the label on the Ortho Evra Contraceptive Transdermal Patch would include the results of a study in women ages 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 F.D.A.’s deputy commissioner for scientific and medical programs.

The agency said it believed the patch was a safe and effective method of contraception, but recommended 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 bloodstream. 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, the F.D.A. said.


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