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WARNING: Diflucan (Fluconazole) During Pregnancy May Be Associated with Birth Defects

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On August 3, 2011 the Food and drug Administration (FDA) released a warning regarding the use of Diflucan (Fluconazole) during pregnancy. According to the FDA, birth defects may be associated with the long-term use of high dose (400-800 mg/day) diflucan (fluconazole) in the first trimester of pregnancy. Diflucan is used to treat yeast infections and meningitis caused by a particular type of fungus.

The FDA has changed diflucan from a Pregnancy C category medication to a pregnancy D category medication. Wikipedia defines a Pregnancy D category medication as one which "[t]here is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks." Pregnancy C category is a class of medication that have been shown to have adverse effects in animals, but there aren't any well-structured human studies available.

The following birth defect characteristics have been associated with the use of long-term, high-dose diflucan:

 

 

      
  • Short, broad head
  • Abnormal looking face
  • Abnormal development of the skullcap
  • Oral cleft (opening in the lip or palate)
  • Bowing of the thigh bones
  • Thin ribs and long bones
  • Muscle weakness and joint deformities
  • Congenital (present at birth) heart disease

Treatment of vaginal yeast infections with a single dose of 150 mg diflucan has not been associated with an increase risk of birth defects and remain a Pregnancy Category C medication. If you are pregnant and taking fluconazole, be sure to talk with your healthcare provider regarding the safety of this medication and report any side effects to the FDA MedWatch program.

Source:
FDA Drug Safety Communication:Use of long-term, high-dose Diflucan (fluconazole) during pregnancy may be associated with birth defects in infant
Wikipedia: Pregnancy Category

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