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Diflucan® and Joint Deformities

The U.S. Food and Drug Administration (FDA) published a safety announcement on Aug. 3, 2011 to notify the public about the risk of dangers to infants whose mothers use long-term high-doses of Diflucan® (fluconazole) during their pregnancies. Among the birth defects found in this small group of mothers were muscle weakness and joint deformities.

Other birth defects were found in these infants, who as fetuses were exposed to 400 to 800 mg per day for part or all of the first trimester of their mothers' pregnancies. The other birth defects included:

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

The FDA made clear that women who take a one-time dose of 150 mg of Diflucan® (fluconazole) to treat vaginal yeast infections were not putting their infants at risk.

FDA Warning

The agency said it found several case reports in the medical literature that described "rare and distinct congenital anomalies" in the newborns of mothers who took chronic, high doses (400mg to 800 mg) of Diflucan® in the first trimester of their pregnancies. The FDA announcement described the five cases as:

  • Four women who took chronic high doses of intravenous Diflucan® for coccidiodal meningitis
  • One woman who was HIV-positive and was taking chronic high oral doses of Diflucan to treat vaginal candidiasis (yeast infection)

The combination of birth defects described above occurs rarely in the general population, the FDA said in its announcement. This combination is similar to abnormalities displayed in animals that have been exposed in utero (while in the uterus) to Diflucan®.

While chronic high-dose use of Diflucan® may cause birth defects in humans, the magnitude of the risk is unknown, the FDA said. The five cases reported might suggest a dose-related effect, according to the federal agency.

Diflucan® is an anti-fungal medication used to treat yeast infections of the vagina, mouth, throat, esophagus, other organs and the blood. It also is used to treat meningitis that a certain type of fungus causes. In addition, it is given to patients about to have a bone marrow transplant and who are being treated with chemotherapy or radiation therapy.

The medication is made by Pfizer, one of the world's largest research and development pharmaceutical companies.

Contact a Diflucan® Birth Defect Lawyer

If your baby is suffering from joint deformities or other congenital abnormalities and you took Diflucan® during your pregnancy, you may be eligible to pursue damages. To learn more, please schedule a free consultation with a Diflucan® birth defect lawyer today.

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