December 7, 2011
FDA Considers Blood Clot Warning On Birth Control Pill Yaz
The Food and Drug Administration said on Tuesday that they are leaning towards adding new information about the risk of blood clots to labels of birth control pills.
The FDA said there is conflicting evidence about the risk, but the information should still appear in labeling used by doctors and patients.
"We believe that, because of the consistency in recent reports for an increased risk, product labeling should reflect that very real possibility," the FDA said.
The agency will ask a panel of outside experts to weigh in on the issue on Thursday. They will ask them to consider whether some women should not take the drugs.
Over the past two years, several studies have suggested that the rate of blood clots with drospirenone, a manmade hormone in several birth controls, is slightly higher than with other hormone-based contraceptives.
The most recent analysis by FDA believes that 10 in 10,000 women on the newer drugs will experience a blood clot per year, compared with 6 in 10,000 women in older contraceptives.
Studies by Bayer, the drug maker who markets Yaz and Yasmin, found no increased risk of blood clots.
FDA scientist say none of the existing studies provide a definitive answer and that new studies are needed.
"The entire body of studies provides conflicting evidence that cannot be easily reconciled by any single difference among studies," states the agency's review.
FDA scientists say the risk of blood clots appears most likely in the first 3 to 6 months taking a drug, and increases among older women.
Most birth control drugs use a combination of two female hormones, estrogen and progestin to help stop ovulation and thicken cervical mucus.
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