FDA evaluating the safety of oral fluconazole in pregnancy.

In the light of new evidence linking oral fluconazole to miscarriages the FDA is currently reviewing the safety of oral fluconazole as a vaginal yeast infection treatment in pregnancy. This review comes in the wake of Danish study published in JAMA which reports abnormalities at birth when  oral fluconazole is taken in higher dose of 400-800 mg/day.

It was a Nationwide register-based cohort study in Denmark from 1997-2013. From a cohort of 1,405, 663 pregnancies, 3315 women were exposed to oral fluconazole from 7 through 22 weeks’ gestation. About 147 experienced a spontaneous abortion compared with 563 among 13,246 unexposed matched women (HR 1.48).

The current FDA drug label states that data available from studies in people do not suggest an increased risk of problems during pregnancy or abnormalities in developing babies when women are exposed to a single 150 mg dose of oral fluconazole to treat vaginal yeast infections.

FDA cautions the healthcare professionals about the use of this drug until the review is complete. The agency has previously classified it as  pregnancy class D, meaning that there is evidence of risk to the fetus, but it may be used if the mother's condition is serious or life-threatening.

CDC guidelines also recommend only using topical antifungal products to treat pregnant women with vulvovaginal yeast infections, including for longer periods than usual if these infections persist or recur.

FDA is also urging people and researchers to report any untoward effects of the drug. It is also reviewing additional data related to the drug use in pregnancy.

In addition to its use as antifungal for vaginal yeast infection, it is also used to treat infection of mouth, and esophagus. fungal infection of the brain and spinal cord called cryptococcal meningitis.

References:

Mølgaard-Nielsen D, Svanström H, Melbye M, Hviid A, Pasternak B. Association Between Use of Oral Fluconazole During Pregnancy and Risk of Spontaneous Abortion and Stillbirth. JAMA. 2016;315(1):58-67. doi:10.1001/jama.2015.17844.

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm497656.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery