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FDA reviewing safety of oral fluconazole among pregnant women
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In light of a recent Danish study indicating a possible association between oral fluconazole and miscarriage, the FDA announced today it will be conducting a review of available safety data and advises caution when prescribing the generic treatment during pregnancy.
While the current drug label does not indicate an increased risk for pregnancy-related adverse events when women are exposed to a single 150-mg dose of oral fluconazole, the FDA wrote that recommendations could be modified after the review is completed.
Oral fluconazole is indicated for the treatment of vaginal, oropharyngeal and esophageal candidiasis, as well as cryptococcal meningitis. Multiple high doses of oral fluconazole (400 to 800 mg/day) have been reported to result in birth abnormalities, the agency wrote, although the majority of oral fluconazole use reported in the Danish study appeared to be one or two doses of 150 mg.
In 2011, the FDA issued a warning due to evidence linking high-dose fluconazole treatment taken during the first trimester of pregnancy with Antley-Bixler syndrome, a rare and distinct array of birth defects including brachycephaly and congenital heart disease. This warning, however, did not extend to a single, standard 150-mg dose.
Patients should notify a health care provider if they are pregnant or actively trying to become pregnant while taking oral fluconazole to discuss alternative treatment options, the agency wrote. In addition, health care providers should inform patients of potential adverse events, which should be reported to the FDA’s MedWatch program should they occur.
“Fluconazole … has a well-established benefit risk profile supported by more than 25 years of patient experience,” Pfizer, which manufactures the generic treatment under the brand name Diflucan, told Infectious Disease News. “As with all our medicines, the benefit/risk profile of fluconazole is continually monitored on a regular basis and as new information becomes available through the literature, clinical studies, spontaneous reports and safety database searches to ensure that the benefits and risks are accurately described in the product label.”