an oral antifungal sometimes prescribed in pregnancy may be associated with spontaneous abortion.
Pregnant women are at increased risk of developing vaginal yeast infection candidiasis due to increased secretion of sex hormones; in the US, about 10% of pregnant women develop the disease.
While intravaginal topical formulations of azole antifungals are the first-line treatment for pregnant women, often oral fluconazole is used.
However, there is a lack of safety information for the drug; In addition, previous studies have suggested evidence of a different pattern of craniofacial birth defects and skeletal in babies born to women treated with long-term high-dose fluconazole during pregnancy.
Enterprise Mølgaard-Nielsen, of Statens Serum Institut in Copenhagen, Denmark, and colleagues evaluated the association between exposure to oral fluconazole during pregnancy and the risk of spontaneous abortion and stillbirth.
In a cohort study across the country, the team studied 1,405,663 pregnancies from 1997 to 2013 in Denmark.
oral fluconazole increases the risk of pregnancy loss
Each fluconazole pregnancy exposed orally compared with up to four pregnancies exposed, grouped by maternal age, calendar year and gestational age. prescriptions filled for oral fluconazole were obtained from the National Register of prescription.
The results showed a significantly increased risk of spontaneous abortion associated with fluconazole exposure. Among 3,315 women exposed to oral fluconazole from 7 to 22 weeks gestation, 147 experienced a spontaneous abortion, compared with 563 among 13,246 women who were not exposed to antifungals.
The association between exposure to fluconazole and fetal death was not significant: 5,382 women exposed to fluconazole week of gestation until birth 7, 21 experienced a stillbirth, compared with 77 women among 21,506 matched unexposed. However, the researchers note that, since the number of fetal deaths in general was low, more information is needed to draw definitive conclusions about the risk.
Compared with topical azole exposure, 130 of 2823 women exposed to fluconazole had a spontaneous abortion, compared to 118 of 2823 exposed to topical azoles; 20 of 4,301 women exposed to fluconazole had a stillbirth, compared with 22 of the 4,301 who were exposed to topical azoles.
A possible confounding factor might be that in the most severe cases of vaginal candidiasis, candida can ascend from the vagina to cause intrauterine candidiasis, which can lead to premature birth and fetal loss.
However, the authors comment:
“oral fluconazole use in pregnancy was associated with a significantly increased risk of spontaneous abortion. Until more data on the association is available, the prudent prescription of fluconazole in pregnancy may be advisable. Although the risk of fetal death was not significantly increased, this result should be investigated further. “
Medical News Today previously reported that some antifungal medications may pose a risk of skin cancer in patients with lung transplantation .