Diflucan® and Bowing of the Thigh Bones
The antifungal medication Diflucan® (fluconazole) has been associated with a specific set of birth defects when taken by the mother in high doses during most or all of the first trimester of her pregnancy.
Diflucan® is used to treat fungal infections, including yeast infections of the vagina, mouth, throat, esophagus and other organs. It is also used to treat meningitis caused by a fungus and is used to prevent yeast infections in females being treated by chemotherapy or radiation, since their immune systems are compromised by the therapy.
The rare set of distinct birth defects, when they occur together, is called the Antley-Bixler syndrome, a severe and rare recessive genetic disorder. These defects include malformations of the following:
- Thigh bones (bowing)
- Ribs and long bones (thin and long)
- Club feet
- Muscle weakness and joint deformities
These defects are similar to those found in animal studies of Diflucan®.
Bowing of the Thigh Bones
The thigh is the upper region of the leg between the knee and the groin. It is one of the body's strongest bones. Bowing of the thigh bone is one of the characteristics of Antley-Bixler syndrome.
The medical literature contains several reports of this set of distinct birth defects in babies born to mothers taking doses between 400 mg and 800 mg to treat fungal infections in the first trimester of their pregnancy. Four of the cases involved women receiving high-dose intravenous fluconazole for coccidiodal (a type of fungus) meningitis. One case was an HIV-positive woman receiving high dose chronic oral fluconazole for vaginal candidiasis.
The infants of all five of these women shared some of the characteristics of Antley-Bixler syndrome, a disorder that occurs rarely in the general population. Because of the occurrence of these birth defects, the Food and Drug Administration (FDA) changed the pregnancy category of Diflucan® from pregnancy category C to pregnancy category D.
Pregnancy category D means there is "positive evidence of human fetal risk based on human data, but the potential benefits from use of the drug in pregnant women with serious or life-threatening conditions may be acceptable despite its risks," according to the FDA.
Contact a Diflucan® Birth Defect Lawyer
If your baby is born with a birth defect and you took Diflucan® during your pregnancy, you may be eligible for compensation. To learn more, schedule a free case review with an experienced birth defect lawyer today.
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