Is fluconazole (Diflucan) safe during pregnancy?

From the Guidelines

Diflucan (fluconazole) should be avoided during pregnancy, especially in the first trimester, unless the potential benefit clearly outweighs the risk. For pregnant women with vaginal yeast infections, topical antifungal treatments like clotrimazole or miconazole are preferred as first-line therapy. These medications come as vaginal creams or suppositories and are considered safe during all trimesters. If oral fluconazole is absolutely necessary, a single 150mg dose may be considered for severe infections unresponsive to topical treatments, but only after the first trimester when possible. The concern with fluconazole in pregnancy stems from case reports linking high-dose, long-term use (400mg or more daily) to birth defects, particularly craniofacial and skeletal abnormalities, as reported in studies 1.

Some key points to consider:

• High-dose fluconazole use during the first trimester has been associated with birth defects, including craniofacial and skeletal abnormalities 1.
• Topical antifungal treatments are preferred for vaginal yeast infections during pregnancy, as they are considered safe and effective 1.
• If oral fluconazole is necessary, a single 150mg dose may be considered after the first trimester, but caution is still warranted due to potential risks 1.
• Pregnant women should always consult their healthcare provider before taking any medication, including over-the-counter antifungals, to ensure the safest approach for both mother and baby.

It's essential to weigh the potential benefits and risks of fluconazole use during pregnancy, considering the severity of the infection and the gestational age of the fetus, as recommended by the Infectious Diseases Society of America 1.

From the FDA Drug Label

Use in pregnancy should be avoided except in patients with severe or potentially life-threatening fungal infections in whom fluconazole may be used if the anticipated benefit outweighs the possible risk to the fetus A few published case reports describe a 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. These reported anomalies are similar to those seen in animal studies Epidemiological studies suggest a potential risk of spontaneous abortion and congenital abnormalities in infants whose mothers were treated with 150 mg of fluconazole as a single or repeated dose in the first trimester, but these epidemiological studies have limitations and these findings have not been confirmed in controlled clinical trials. If fluconazole is used during pregnancy, or if the patient becomes pregnant while taking the drug, the patient should be informed of the potential hazard to the fetus Effective contraceptive measures should be considered in women of child-bearing potential who are being treated with fluconazole 400 to 800 mg/day and should continue throughout the treatment period and for approximately 1 week (5 to 6 half-lives) after the final dose

Diflucan use in pregnancy should be avoided unless the patient has a severe or potentially life-threatening fungal infection and the anticipated benefit outweighs the possible risk to the fetus 2.

• High-dose fluconazole (400 to 800 mg/day) during the first trimester has been associated with a pattern of distinct congenital anomalies in infants.
• Low-dose fluconazole (150 mg) has been suggested to have a potential risk of spontaneous abortion and congenital abnormalities, but this has not been confirmed in controlled clinical trials 2.
• Contraceptive measures should be considered in women of child-bearing potential who are being treated with high-dose fluconazole.
• Patient education is crucial, and patients should be informed of the potential hazard to the fetus if fluconazole is used during pregnancy.

From the Research

Diflucan Use in Pregnancy

• Diflucan, also known as fluconazole, is used to treat vulvovaginal candidiasis during pregnancy 3, 4.
• However, there are concerns regarding the pregnancy outcomes following exposure to fluconazole, particularly during the first trimester 3.
• A systematic review and meta-analysis found that oral fluconazole use during the first trimester of pregnancy was marginally associated with an increased risk of congenital malformations, especially heart malformations and spontaneous abortion 3.

Risks Associated with Diflucan Use

• High-dose fluconazole use (>150 mg) during the first trimester of pregnancy was associated with an increased risk of congenital malformations, including heart malformations and cardiac septal defects 3.
• Exposure to fluconazole was also significantly associated with an increased risk of spontaneous abortion 3.
• Another study found that recent data have clarified the teratogenic effect of high-dose fluconazole during the first trimester, but provided reassuring cumulative data regarding its use at a single low dose in this key period 4.

Treatment of Vulvovaginal Candidiasis

• Fluconazole has been shown to be effective in treating vulvovaginal candidiasis, with minimal adverse effects 5, 6.
• Weekly fluconazole therapy for six months has been found to be effective in reducing symptomatic episodes of recurrent vulvovaginal candidiasis 6.
• New antifungal medications for vulvovaginal candidiasis are available, and nurses should be up-to-date on diagnosis and treatment options 7.