Miscarriage Risk Seen for Fluconazale

Pregnant women with vaginal yeast infections should avoid taking oral fluconazole. Dutch researchers reporting in a study published in JAMA said using that drug during pregnancy carried an increased risk of spontaneous abortion.

“Until more data on the association are available, cautious prescribing of fluconazole in pregnancy may be advisable,” the researchers from the Department of Epidemiology Research in Copenhagen concluded. The study did not find a statistically significant association between the drug and still births, but the authors Ditte Molgaard-Nielsen, MSc and colleagues recommended further investigation.

About 10 percent of pregnant women in the U.S. experience vaginal candidiasis, according to a 1998 American study. Topical azoles usually are the first-line treatment, but fluconazole may be used because of personal preference, the topical treatment failure, recurrence or the severity of the infections, the Danes explained.

The nationwide cohort study covering a 17-year period found a 48 percent increased chance of spontaneous abortions between weeks 7 and 22 gestation among the 3,315 pregnancies where women used fluconazale. (HR 1.48; 95% CI) That is in comparison with a matched control group of 13,246 pregnancies where women did not use fluconazale.

The authors based their findings on data from 1997 through 2013 derived from Danish national registers for patients, medical births, prescriptions, persons and from Statistics Denmark.

Researchers in two earlier studies did not find a similar increased risk with the use of fluconazole.

However, Molgaard-Nielsen and colleagues noted that their own sample was twice the combined size of 1512 patients in the previous studies. They suggested the previous studies may not have had "sufficient [statistical] power to detect "even a moderate risk."