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Monistat Labeling To Carry Vaginal Miconazole/Warfarin Interaction Warning

This article was originally published in The Tan Sheet

Executive Summary

Johnson & Johnson Personal Products will update the labeling for its miconazole-containing Monistat 3 and Monistat 7 yeast infection treatments within the year to note the possible interaction between vaginal miconazole and the Rx blood-thinning medication warfarin.

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Agency cautions consumers against use of Tao Chih Pien pediatric product with unlabeled aristolochic acid in Aug. 24 warning. Customs alert has been issued for item, manufactured by TianJin Medicines & Health Products Import & Export Corp. (China). Health Canada released a separate consumer reminder on aristolochic acid risks Aug. 17. Warning of potential interaction between OTC vaginal miconazole products and Rx blood-thinning agent warfarin also recently issued by agency, following similar FDA "Talk Paper" in March (1"The Tan Sheet" March 12, p. 4). Both agencies are asking manufacturers to add new warning statements to labeling

Health Canada

Agency cautions consumers against use of Tao Chih Pien pediatric product with unlabeled aristolochic acid in Aug. 24 warning. Customs alert has been issued for item, manufactured by TianJin Medicines & Health Products Import & Export Corp. (China). Health Canada released a separate consumer reminder on aristolochic acid risks Aug. 17. Warning of potential interaction between OTC vaginal miconazole products and Rx blood-thinning agent warfarin also recently issued by agency, following similar FDA "Talk Paper" in March (1"The Tan Sheet" March 12, p. 4). Both agencies are asking manufacturers to add new warning statements to labeling

Health Canada

Agency cautions consumers against use of Tao Chih Pien pediatric product with unlabeled aristolochic acid in Aug. 24 warning. Customs alert has been issued for item, manufactured by TianJin Medicines & Health Products Import & Export Corp. (China). Health Canada released a separate consumer reminder on aristolochic acid risks Aug. 17. Warning of potential interaction between OTC vaginal miconazole products and Rx blood-thinning agent warfarin also recently issued by agency, following similar FDA "Talk Paper" in March (1"The Tan Sheet" March 12, p. 4). Both agencies are asking manufacturers to add new warning statements to labeling

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