Pregnant women taking high doses of Diflucan during their first trimester of pregnancy should take heed: Their infants are at an increased risk of developing rare, specific birth defects.
The Food and Drug Adminsitration ("FDA") is changing the safety profile of Diflucan (fluconazole), which is most commonly used for treating many types of yeast infections, from C to D for pregnant women. The change to Pregnancy Category D means that there is positive evidence of fetal risk based on human data. The FDA is cautioning healthcare professionals to counsel their patients on potential risks if they are taking the drug while pregnant, or become pregnant while taking the drug.
Cases associated with high-dose fluconazole use all shared some characteristics with the autosomal recessive genetic disorder known as Antley-Bixler syndrome, which is a congenital disorder characterized by malformations and deformities affecting the majority of the skeleton and other areas of the body. Deformities associated with Antley-Bixler include cranio-facial deformities, bowed legs, Urogenital anomalies (ambiguous genitalia), clubfoot, and vertebral body anomalies.
Sheller, P.C. currently is investigating possible claims related to birth defects associated with use of Diflucan or fluconazole. If you or someone you know has taken Diflucan during pregnancy that may be related to birth defects described above, call 1-800-883-2299.
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