FOOD AND DRUG ADMINISTRATION EVALUATING SAFETY OF FLUCONAZOLE (DIFLUCAN) IN PREGNANCY

May 6, 2016

Here’s an important alert for pregnant women considering using fluconazole pills for yeast infections.

On April 26, 2016, the Food and Drug Administration (FDA) announced that it is evaluating the safety of oral fluconazole (DIFLUCAN) for yeast infections in pregnancy after a Danish study indicated that use of this drug may increase the risk of miscarriage.[1]

Fluconazole pills are commonly used to treat yeast infections in the vaginal area. For these infections, the recommended dosage is a single 150 milligram (mg) pill, taken one time.[2] Multiple higher doses are also sometimes used to treat and prevent fungal infections in the mouth and throat and throughout the body, particularly in patients with weakened immune systems.

Studies previously have shown no increased risk of birth defects or other problems in women taking a single 150 mg dose of oral fluconazole.[3] However, there have been reported cases of several birth defects in newborns whose mothers took high doses of fluconazole (400-800 mg per day) during most or all of the first trimester of pregnancy.[4]

The Danish study found that women taking as little as one or two 150 mg pills of fluconazole to treat vaginal yeast infections had about a 50 percent higher risk of miscarriage compared to women not treated with fluconazole.[5] However, this particular study did not assess the risk of birth defects.

The Centers for Disease Control and Prevention (CDC) currently recommends against using antifungal pills, including fluconazole pills, to treat vaginal yeast infections in pregnancy.[6] Instead, the CDC recommends using a topical antifungal drug, such as clotrimazole (GYNE-LOTRIMIN) or miconazole (MONISTAT), applied as a vaginal cream or suppository for seven days.[7]

What you can do

• If you are pregnant, avoid taking antifungal pills for vaginal yeast infections, including fluconazole.
• For vaginal yeast infections during pregnancy, consult with your obstetrician. Over-the-counter topical clotrimazole or miconazole for seven days are standard treatments for yeast vaginitis during pregnancy.
• If you took fluconazole during pregnancy and experienced an adverse effect (including a miscarriage, stillbirth, or birth defect), report it to the FDA’s MedWatch program at http://www.fda.gov/medwatch.

To see the FDA safety communication, visit the following link:
http://www.fda.gov/Drugs/DrugSafety/ucm497482.htm

References

[1] Mølgaard-Nielsen D, Svanström H, Melbye M, et al. Association between use of oral fluconazole during pregnancy and risk of spontaneous abortion and stillbirth. JAMA. 2016;315(1):58-67. doi: 10.1001/jama.2015.17844.

[2] DailyMed. LABEL: DIFLUCAN-fluconazole tablet. Updated March 15, 2016. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=f694c617-3383-416c-91b6-b94fda371204. Accessed May 2, 2016.

[3] Ibid.

[4] Ibid.

[5] Mølgaard-Nielsen D, Svanström H, Melbye M et al. Association between use of oral fluconazole during pregnancy and risk of spontaneous abortion and stillbirth. JAMA. 2016;315(1):58-67. doi: 10.1001/jama.2015.17844.

[6] Centers for Disease Control and Prevention. Vulvovaginal candidiasis. Page last reviewed: June 4, 2015. http://www.cdc.gov/std/tg2015/candidiasis.htm. Accessed May 2, 2016.

[7] Ibid.

[8] Sobel JD. Candida vulvovaginitis. UpToDate. Last updated January 11, 2016.