The findings of new research suggests that side effects of Diflucan during pregnancy may increase the risk of a miscarriage, or result in children developing heart birth defects.
In a study published in the Canadian Medical Association Journal (CMAJ) on February 19, researchers with the University of Montreal report that low doses of Diflucan were linked to a twofold increase in the risk of miscarriage when taken by pregnant women. Higher doses appeared to more than triple that risk.
Diflucan (fluconazole) is a prescription drug introduced by Pfizer used to treat yeast infections of the vagina, mouth, esophagus and other organs. It is also used to treat some kinds of meningitis and used as a yeast infection preventative among individuals being treated with chemotherapy or radiation therapy before receiving a bone marrow transplant.
In recent years, case reports have suggested that there may be a Diflucan birth defect risk, with a pattern seen among children born to women prescribed high-doses of the medication to treat severe fungal infections during pregnancy.
In April 2016, the FDA warned doctors to be cautious about prescribing Diflucan during pregnancy, and urged women who are pregnant or trying to get pregnant to talk to their doctors about other treatment options for yeast infections.
In this latest study, researchers looked at data from the Quebec Pregnancy Cohort from 1998 to 2015 and identified women exposed to doses of Diflucan under or over 150 mg, as well as women who were not exposed. The researchers looked for cases of spontaneous abortion or stillbirth, and major congenital malformations.
Researchers found that the use of Diflucan during early pregnancy more than doubled the risk of spontaneous abortion when compared to pregnant women who had no exposure at doses of 150 mg or less. At higher doses, the risk more than tripled.
The findings also indicate that Diflucan exposure during the first trimester did not increase the risk of overall major congenital defects, but they say it did nearly double the risk of cardiac septal closure anomalies.
“Our nested case–control studies within a large population-based pregnancy cohort showed that fluconazole exposure (any dose) during early pregnancy is associated with an increased risk of spontaneous abortion, and use of high-dose fluconazole in the first trimester is associated with an increased risk of septal closure anomalies,” the researchers concluded. They warned that a substantial number of women appear to be taking the drug during pregnancy,
The FDA safety review in 2016 came after Dutch researchers also warned of a potential link between the anti-fungal medication and miscarriages. They calculated Diflucan exposure during early pregnancy increased the risk of spontaneous abortion by about 48%.
Case studies have linked Diflucan to birth defects when taken in the first trimester, at time when many woman do not even know they are pregnant.
According to the FDA, birth defects from Diflucan have been seen in infants exposed to long-term, high-doses during the first trimester included abnormal head, skull and face defects, cleft palate, cleft lip, bowing of the thigh bones, thin ribs, long bones, muscle weakness, joint deformities and congenital heart disease at birth.