Is Diflucan® Safe During Pregnancy?

Chronic, high dose use of Diflucan® may be associated with a rare and distinct set of birth defects, according to the Food and Drug Administration (FDA).

The FDA issued a safety announcement Aug. 3, 2011, saying that five cases of birth defects have been reported in babies born to mothers taking high doses of Diflucan® in the first trimester of pregnancy. The birth defects in all cases can be grouped into a set of anomalies that occur in the Antley-Bixler syndrome.

The announcement said that low doses of the drug, such as the single 150 mg dose used to treat vaginal yeast infections, have not been connected to birth defects.

The FDA changed the pregnancy category of Diflucan from category C to category D. This means there are positive human data showing the drug causes birth defects. (The pregnancy category for patients with a vaginal yeast infection remains a category C.)

Possible Birth Defects Due to the Use of Diflucan®

Some of the following birth defects occurred in babies born to mothers taking Diflucan® at high doses during the first four weeks of pregnancy:

• Short, broad head
• Abnormal-looking face
• Abnormal development of the skullcap
• Oral cleft (an opening in the lip or palate)
• Bowing of the thigh bones
• Thin ribs and long bones (thigh bones and finger bones)
• Muscle weakness and joint deformities
• Congenital heart disease

Patients taking Diflucan® should let their doctors know if they are pregnant or planning to become pregnant.

Five case reports of birth defects involved mothers taking between 400 mg and 800 mg over time during the first trimester of their pregnancies. Four of the reports had to do with mothers who took chronic high doses of Diflucan® intravenously for coccidiodal meningitis. One report concerned a pregnant woman who was HIV-positive and took chronic high dose Diflucan® for vaginal candidiasis (yeast infection).

Facts about Diflucan®

Diflucan® is used:

• To treat yeast infections of the vagina, throat, esophagus and other organs
• To treat meningitis caused by a certain type of fungus
• To prevent yeast infections in candidates for bone marrow transplants who receive chemotherapy or radiation therapy before the transplantation
• As a single dose of 150 mg to treat vaginal candidiasis (this is much lower than its use for other indications)

If you were given Diflucan® during your pregnancy and your baby had complications, our birth defect lawyers may be able to help you seek compensation. To schedule a consultation with a qualified Diflucan® birth defect lawyer, please contact use today.