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Scott Kappes
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FDA Warns of Birth Defect Risks Associated with High-Dose Use of Diflucan during Pregnancy

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The FDA has recently issued a warning that long-term, high-dose use of the anti-fungal medication Diflucan may cause birth defects if taken by pregnant mothers during the first trimester of pregnancy. The risk does not appear to be associated with single, low-dose uses of the medication often used to treat yeast infection in women, but risks greatly increase with higher doses and prolonged use.

Diflucan is most commonly used to treat yeast infections of the vagina, mouth, throat, esophagus and other organs. The medication is also used to treat certain types of meningitis, as well as to prevent yeast infections in patients who are likely to become infected because they are being treated with chemotherapy or radiation therapy before a bone marrow transplant.

The FDA is aware of several published case reports of birth defects in infants whose mothers were treated with high doses of Diflucan to combat serious fungal infections during the first trimester of pregnancy.

Based on the evidence indications of Diflucan, other than single dose uses, have been changed from pregnancy category C to pregnancy category D. This classification means that there is positive evidence of risk to the human fetus based on human data.

In some instances the benefits of using the medication to treat serious and life-threatening infections may be acceptable despite the known risks.

For more information please see the FDA’s recent Drug Safety Communication for Diflucan here.