Antifungal pregnancy risk warning


Regulators are warning women of a possible risk of miscarriage following use of an oral antifungal.

The US Food and Drug Administration has issued an announcement in late April advising caution when prescribing oral fluconazole (Diflucan) in pregnancy.

They say an evaluation of data from a Danish study indicates a possible increased risk of miscarriage when fluconazole is used to treat yeast infections.

The Danish study examined a cohort of 1,405,663 pregnancies and compared oral fluconazole-exposed pregnancies with up to 4 unexposed pregnancies matched on propensity score, maternal age, calendar year, and gestational age.

The researchers found a significantly increased risk (48%) of spontaneous abortion associated with fluconazole exposure.

No significant association was found between fluconazole exposure and stillbirth.

In the study, most of the oral fluconazole use appeared to be 1 or 2 doses of 150mg.

A spokesperson for the Department of Health said the TGA “is aware of the FDA’s announcement and is reviewing information to determine whether there are concerns in Australia”.

Currently, the approved drug label in the US states that available data does not suggest an increased risk of problems during pregnancy or fetal abnormalities when women are exposed to a single fluconazole 150mg dose to treat vaginal yeast infections.

However, abnormalities at birth have been reported in pregnant women who take high doses (400–800mg/day) for longer than a single dose, the FDA says.

The FDA is reminding US healthcare professionals that the Centers for Disease Control and Prevention (CDC)’s guidelines recommend only using topical anti-fungals to treat pregnant women with vulvovaginal yeast infections, including for a longer duration if the infections persist or recur. Patients who are pregnant or trying to conceive should discuss with their healthcare professional about alternative options for yeast infections.

The FDA is continuing to evaluate additional data and will release final conclusions and recommendations upon completing their review.

 

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