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FDA Updates Safety Information For Miconazole Vaginal Cream And Suppositories.(women who take warfarin should consult their physician or pharmacist before using over-the-counter miconazole)
2001 MAR 29 -- (NewsRx.com & NewsRx.net) -- The U.S. Food and Drug Administration (FDA) is advising women who take the prescription blood-thinner warfarin to consult their doctor or pharmacist for advice before using an over-the-counter vaginal miconazole product.
FDA has also advised manufacturers of vaginal creams and suppositories containing miconazole to add a new warning to the Drugs Facts box on product labels. The warning states: "Ask a doctor or pharmacist before use if you are taking the prescription blood thinning medicine warfarin, because bleeding or bruising may occur."
FDA is taking this action because the agency has received two adverse events indicating abnormal blood clotting tests with women who took anticoagulant therapy and used vaginal miconazole. In addition to abnormal tests, one woman developed bruises, bleeding gums, and a nosebleed.
Two articles from medical journals reported cases of probable warfarin interaction with vaginal miconazole. The agency believes that ...
- Warfarin interactions prompt FDA warning.(Food and Drug Administration)(Brief...
- Magazine article from: Medical Marketing & Media Dickinson, James G. April 1, 2001 700+ words
...took anticoagulent therapy while using non-prescription vaginal miconazole cream have prompted the FDA to require manufacturers of miconazole creams and suppositories...interaction between warfarin and miconazole is well known, the FDA said.
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...reports of interactions between the drugs. The agency received two reports of abnormal blood clotting tests in women who took warfarin and used vaginal miconazole. One of the women also developed bruises, bleeding gums, and a nosebleed.
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Source: HighBeam Research, FDA Updates Safety Information For Miconazole Vaginal Cream And...