Diflucan® and Abnormal Face Defects
The anti-fungal drug Diflucan® (fluconazole), when taken in chronic high doses by a woman in the third trimester of pregnancy, can lead to a rare and distinct set of birth defects, including abnormal face defects. The U.S. Food and Drug Administration (FDA) issued a safety announcement to notify consumers and health care providers about the possible connection between the drug and birth defects in August 2011.
Called the Antley-Bixler syndrome, the cluster of birth defects include:
- Short, broad head
- Abnormal looking face
- Abnormal development of the skullcap
- Oral cleft (opening in the lip or the palate)
- Thin ribs and long bones (the thigh and fingers)
- Muscle weakness and joint deformities
- Congenital heart disease
The FDA said it based its findings on published case reports of birth defects in newborns whose mothers were treated with high doses of fluconazole. According to the FDA safety communication, five patients had infants with some of the above birth defects.
All were receiving high chronic doses (400 mg to 800 mg per day) of the medication. Four of the women received intravenous Diflucan® for coccidiodal meningitis. The fifth woman was an HIV patient with vaginal candidiasis. The high dose was given to the HIV patient because of the susceptibility to infections caused by her illness.
Patients with vaginal yeast infections usually receive a single 150 mg dose of Diflucan®. There is no evidence suggesting a low dose of the drug leads to birth defects, the FDA reports.
Pregnancy Category Change Amid Facial Defects
Because of the occurrence of birth defects in the five women, the FDA changed the pregnancy category of the drug from a category C to a category D, except for women taking a single 150 mg dose of the drug to treat vaginal yeast infections. Drugs in category D have been shown to cause birth defects in humans. Category C drugs have been shown in animal studies to have an adverse effect on the fetus, but there are no adequate and well-controlled studies in humans.
Diflucan® is prescribed to treat yeast infections of the vagina, mouth, throat, esophagus, other organs and blood. It is used to treat meningitis caused by a certain type of fungus. It also is used by patients who receive chemotherapy or radiation therapy before having a bone marrow transplant.
The FDA advises patients to notify their doctors if they become pregnant or intend to become pregnant while taking Diflucan®.
If your baby is born with a birth defect and you were given Diflucan® during your pregnancy, you may be eligible to seek compensation for your child's injury. To schedule a free consultation with a Diflucan® birth defect lawyer, please contact us today.
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The U.S. Food and Drug Administration (FDA) issued a safety communication on Aug. 3, 2011 to alert patients and health care... read more