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FDA Drug Safety Podcast for Healthcare Professionals: Use of long-term, high-dose Diflucan (fluconazole) during pregnancy may be associated with birth defects in infants

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Welcome, my name is Steve Jackson, a pharmacist in the Division of Drug Information. On August 3, 2011, the Food and Drug Administration issued a Drug Safety Communication informing the public that chronic, high doses (400-800 mg/day) of the antifungal drug Diflucan, active ingredient fluconazole, may be associated with a rare and distinct set of birth defects in infants whose mothers were treated with the drug during the first trimester of pregnancy. This risk does not appear to be associated with a single, low dose of fluconazole 150 mg to treat vaginal candidiasis.

There are several published case reports of birth defects in infants whose mothers were treated with high-dose fluconazole (400-800 mg/day) for serious and life-threatening fungal infections during most or all of the first trimester.

Based on this information, the pregnancy category for fluconazole indications (other than vaginal candidiasis) has been changed from category C to category D. The pregnancy category for a single dose of fluconazole 150 mg to treat vaginal candidiasis has not changed and remains category C.

Pregnancy category D means there is positive evidence of human fetal risk based on human data but the potential benefits from use of the drug in pregnant women with serious or life-threatening conditions may be acceptable despite its risks.

Healthcare professionals should be aware of the potential risks with long-term, high-dose use of fluconazole and counsel patients if the drug is used during pregnancy or if a patient becomes pregnant while taking the drug.

At this time, FDA recommends that Healthcare Professionals be aware that:

  1. The pregnancy category for a single 150 mg dose of fluconazole for vaginal candidiasis is category C based on data from animal studies that showed an adverse effect on the fetus. There are no adequate and well-controlled studies of fluconazole in pregnant women. Available human data do not suggest an increased risk of congenital anomalies following a single maternal dose of 150 mg.
  2. The pregnancy category for fluconazole use for indications other than vaginal candidiasis is now category D. A few published case reports describe a rare pattern of distinct congenital anomalies in infants exposed in utero to high-dose maternal fluconazole (400-800 mg/day) during most or all of the first trimester.
  3. The features seen in these infants include brachycephaly, abnormal facies, abnormal calvarial development, cleft palate, femoral bowing, thin ribs and long bones, arthrogryposis, and congenital heart disease. These effects are similar to those seen in animal studies.
  4. If fluconazole is used during pregnancy, or if a patient becomes pregnant while taking fluconazole, the patient should be informed of the potential risk to the fetus.
  5. Adverse events involving fluconazole should be reported to the FDA MedWatch program at www.fda.gov/medwatch.

Thank you for listening. The FDA is committed to keeping healthcare professionals informed of the latest safety information. Please read the Drug Safety Communication for the complete Data Summary detailing this communication. A link to this DSC can be found at www.fda.gov/Drugs/DrugSafety. If you have drug questions, you can reach us at druginfo@fda.hhs.gov.

 

 

 

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