Diflucan Miscarriage Risk Draws FDA Safety Review

Federal drug regulators indicate that they are reviewing the potential risk of Diflucan side effects for pregnant women, following a recent study that suggested the anti-fungal medication may increase the risk of miscarriage and birth defects. 

In a Diflucan drug safety communication on April 26, the FDA warn doctors to be cautious about prescribing oral fluconazole (Diflucan) during pregnancy, and urges women who are pregnant or trying to get pregnant to talk to their doctors about other treatment options for yeast infections.

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 in patients being treated with chemotherapy or radiation therapy before receiving a bone marrow transplant.

In recent years, case reports have suggested that side effects of Diflucan may cause a pattern of birth defects when high-doses of the medication are used to treat severe fungal infections during pregnancy.

This recent FDA safety review was initiated after the findings of a Dutch study identified a potential link between Diflucan and miscarriages. After examining data on 1,405,663 pregnancies in Denmark from 1997 to 2013, researchers found that women who took Diflucan before the 22nd week of gestation were more likely to experience a spontaneous abortion, or miscarriage. Researchers calculated the increased risk to be about 48%.

In 2011, the FDA issued a warning that high doses of Diflucan had been associated with birth defects and congenital anomalies. However, the data at the time indicated that the risk was only associated with high doses involving at least 400-800 mgs.

The FDA notes that this new study involved women receiving one or two doses of Diflucan at 150 mg strength.

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, Diflucan birth defects 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.

“Health care professionals should be aware that the Centers for Disease Control and Prevention guidelines recommend only using topical antifungal products to treat pregnant women with vulvovaginal yeast infections, including for longer periods than usual if these infections persist or recur,” the FDA advised. “Patients who are pregnant or actively trying to get pregnant should talk to their health care professionals about alternative treatment options for yeast infections.”