Can pregnant patients take Diflucan (fluconazole)?

From the Guidelines

Fluconazole (Diflucan) should generally be avoided during pregnancy, especially in the first trimester, unless the potential benefit clearly outweighs the risk. For pregnant patients with severe or life-threatening fungal infections, fluconazole may be considered under close medical supervision 1. The concern stems from evidence linking high-dose, long-term fluconazole use (400-800 mg daily) to birth defects, particularly craniofacial and skeletal abnormalities, as reported in studies such as the one by Lopez-Rangel and Van Allen in 2005 1.

Some key points to consider:

• Single low-dose fluconazole (150 mg) for vaginal yeast infections appears to carry lower risk, but alternative treatments are preferred 1.
• Topical antifungal medications like clotrimazole or miconazole are considered safer first-line options for pregnant women with vaginal yeast infections, as they work locally with minimal systemic absorption, reducing potential exposure to the developing fetus.
• The American Academy of Pediatrics has indicated that breastfeeding while receiving fluconazole, but not other currently approved azole antifungals, is likely safe for the newborn 1.
• Any pregnant patient requiring antifungal therapy should discuss their specific situation with their healthcare provider to determine the safest and most appropriate treatment approach based on their individual circumstances and the severity of their infection.

In terms of management during pregnancy, the Infectious Diseases Society of America (IDSA) clinical practice guideline for the treatment of coccidioidomycosis recommends:

• For women who develop initial nonmeningeal coccidioidal infection during their first trimester of pregnancy, intravenous AmB is recommended, with other options including no therapy with close monitoring or an azole antifungal after educating the mother regarding potential teratogenicity 1.
• After the first trimester of pregnancy, an azole antifungal, such as fluconazole or itraconazole, can be considered 1.

From the FDA Drug Label

Pregnancy Category C Single 150 mg tablet use for Vaginal Candidiasis There are no adequate and well-controlled studies of fluconazole in pregnant women. Available human data do not suggest an increased risk of congenital anomalies following a single maternal dose of 150 mg Pregnancy Category D All other indications A few published case reports describe a rare pattern of distinct congenital anomalies in infants exposed in utero to high dose maternal fluconazole (400 to 800 mg/day) during most or all of the first trimester.

Pregnant patients can take a single 150 mg dose of Diflucan (fluconazole) for vaginal candidiasis, as available human data do not suggest an increased risk of congenital anomalies at this dose. However, for all other indications, Diflucan is classified as Pregnancy Category D, and high-dose exposure (400 to 800 mg/day) during the first trimester has been associated with a rare pattern of distinct congenital anomalies. Therefore, if Diflucan is used during pregnancy, the patient should be informed of the potential hazard to the fetus 2.

From the Research

Pregnancy and Diflucan (Fluconazole) Use

• The use of Diflucan (fluconazole) during pregnancy has been studied in several research papers 3, 4, 5, 6, 7.
• Initially, fluconazole was not recommended for use during pregnancy or lactation due to limited data on its safety 3.
• However, a Danish population-based cohort study found no overall increased risk of congenital malformations after exposure to short-course treatment with fluconazole in early pregnancy 4.
• A systematic review and meta-analysis suggested that oral fluconazole use during the first trimester of pregnancy may be associated with an increased risk of congenital malformations, particularly heart malformations, and spontaneous abortion 5.
• Another study found a significantly increased risk of spontaneous abortion associated with fluconazole exposure, but no significant association with stillbirth 6.
• An earlier prescription-event monitoring study reported that fluconazole was taken by 289 women during pregnancy and found no harmful effects on the outcome of pregnancy 7.

Key Findings

• Fluconazole exposure during pregnancy may be associated with an increased risk of congenital malformations, particularly heart malformations 5.
• There is a significantly increased risk of spontaneous abortion associated with fluconazole exposure 6.
• The use of fluconazole during pregnancy should be approached with caution, and alternative treatments should be considered when possible 6.
• More research is needed to fully understand the safety of fluconazole use during pregnancy 4, 5, 6.