FDA Investigates Miscarriage Risk from Oral Diflucan

April 26, 2016 — The FDA has issued a Safety Communication to warn about a possible risk of miscarriage in pregnant women who use oral Diflucan (fluconazole) for yeast infections.

The agency is evaluating results of a Danish study that found a 48% increased risk of spontaneous abortion associated with Diflucan. The study was published in JAMA Internal Medicine in January 2016. The researchers warned:

“Until more data on the association are available, cautious prescribing of fluconazole in pregnancy may be advisable. Although the risk of stillbirth was not significantly increased, this outcome should be investigated further.

The conclusions of the study were based on data from 1.4 million pregnancies in Denmark between 1997 and 2013, including 3,315 women who took oral Diflucan in the first or second trimester of pregnancy (weeks 7 through 22). In most cases, women used one or two 150-mg doses.

The label currently states that studies to not suggest an increased risk of pregnancy problems or birth defects when women take a single 150-mg dose. However, high doses (400-800 mg/day) have been associated with birth defects.

In August 2011, the FDA warned about case reports linking high-dose intravenous (IV) Diflucan and a rare but distinct set of birth defects, including:

• Short, broad head
• Abnormal looking face
• Abnormal skull development
• Cleft palate
• Thin ribs, long bones, and bowed femur
• Muscle weakness and joint deformity
• Congenital heart disease

Yeast infections (vaginal candidiasis) are common during pregnancy. While most women use intravaginal topical creams as a first-line treatment, oral medications are often used despite a lack of safety information.

Diflucan is used to treat yeast infections of the vagina, mouth, and esophagus. It can also treat fungal infections in the brain and spinal cord, a disease known as cryptococcal meningitis that is most common among people with weakened immune systems.

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