The Food and Drug Administration is now advising doctors to be cautious about prescribing the oral yeast infection treatment fluconazole (also known as Diflucan) to pregnant women. This recommendation comes after the drug was found to be linked to an increased instance of miscarriage.
A Danish study found that women exposed to fluconazole at 22 weeks pregnant or less significantly raised their chances of having a miscarriage, compared to women who had not used the drug. No connection of this kind was found for women using oral fluconazole after the 23 week mark.
Researchers at the State Serum Institute in Copenhagen reached this troubling discovery after reviewing medical records that spanned 17 years and included 1.4 million pregnancies. According to the study, “Among 3,315 women exposed to oral fluconazole from 7 through 22 weeks gestation, 147 experienced a spontaneous abortion, compared with 563 among 13,246 unexposed matched women. There was a significantly increased risk of spontaneous abortion associated with fluconazole exposure.”
This common yeast infection treatment is already known to be of questionable safety for pregnant women. In 2011, the FDA released a safety announcement regarding a documented link between pregnant women who used long-term high doses of the drug and a rare set of birth defects in their infants. These effects were seen in babies whose mothers had used the drug over an extended period to treat serious and life-threatening fungal infections.
At that time, fluconazole was changed to a pregnancy category D drug which, according to the FDA, means, “There is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.”
The use of a single dose to treat a yeast infection during pregnancy, however, was left as a category C, which the FDA defines as a drug in which, “Animal reproduction studies have shown adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.”
Yeast infections are a relatively common occurrence for pregnant women when rapidly changing hormones, particularly estrogen, can alter the pH balance of the vagina. Caused by the fungus Candida, this overgrowth of yeast can cause severe itching and abnormal vaginal discharge.
For expectant moms, topical creams are generally considered the first and safest method of treatment for a yeast infection, outside of homeopathic remedies. The Centers for Disease Control agrees, stating, “Only topical azole therapies, applied for 7 days, are recommended for use among pregnant women.” This advice does not, however, stop some doctors from prescribing fluconazole to pregnant women who may be struggling with persistent or recurring yeast issues.
For now, the FDA is only advising caution to doctors who might be considering prescribing fluconazole to pregnant a women. A more in-depth review is underway regarding the drug but it remains unclear if or when the FDA will decide to take further action.