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Michael Monheit
Michael Monheit
Attorney • (215) 840-6573

Craniofacial Differences including Cleft Palate tied to Fluconazole (Diflucan)

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Early this month, the FDA issued a drug safety communication warning the public that long-term use of the anti-fungal drug fluconazole at high dosages during the first trimester of pregnancy may be associated with birth defects in infants. The drug fluconazole is marketed as Diflucan and is typically used to treat fungal infections. This includes yeast infections of the vagina, mouth, throat, esophogas, abdomen, lungs, blood, and other organs. It is also sometimes used to treat meningitis caused by a certain type of fungus.

The dosage that the FDA calls attention to is 400-500 mg of Diflucan per day, as compared to a low dose being at 150 mg/day. At the higher dosage level, a number of published case reports indicate the occurrence of rare birth defects in infants of mothers who were treated with the drug during the first trimester of pregnancy. As a result of these studies, the FDA is changing the pregnancy category of fluconazole from category C to category D, which means that “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.”

Among the birth defects that research has linked to fluconzaole are:

  • Short, broad head
  • Abnormal looking face
  • Abnormal development of the skull cap
  • Oral cleft defects
  • Bowing of the thigh bones
  • Thin ribs and long bones
  • Muscle weakness and joint deformities
  • Congenital heart disease

While most women will not be affected by this new warning, given that it only applies when Diflucan is prescribed at high dosages, if you have been prescribed Diflucan and are pregnant or contemplating pregnancy, it is still an important issue to discuss with your physician. Lower risk alternative treatment options may be available and women need to be fully informed about the risks prior to making these treatment decisions that affect the health of both mother and child.