Diflucan Birth Defects Lawsuit
The FDA recently (August 2011) issued a safety warning regarding the drug Diflucan (fluconazole) and birth defects. The FDA’s studies revealed that the drug Diflucan, often used to treat yeast infections of the vagina, throat, esophagus, and mouth may be linked to causing birth defects when taken by the mother in high dosages. Diflucan is also used as a preventative treatment for patients likely to become infected with yeast infections.
The FDA stated that its findings did not show an increased correlation of Diflucan and birth defects when the mothers took smaller dosages of Diflucan. Typically, the dosage of Diflucan that a woman will take for a yeast infection is a single 150mg Diflucan dose. That lower, one time Diflucan dose does not show a higher risk of birth defects.
The FDA’s warning however, pertains to those taking chronic, high dosages (400-800mg/day) of Diflucan. The long lasting use of high dosages of Diflucan has been linked with a set of rare and distinct birth defects in the babies of mothers who took Diflucan during the first trimester of pregnancy. There doesn’t appear to be a risk of these birth defects when the mother takes only a single, small dose of Diflucan.
There have been multiple published cases of infants suffering from birth defects whose mothers received high dosages of Diflucan during most or all of the first trimester of pregnancy. Due to these increases in birth defects in babies born to mothers taking large dosages of Diflucan, the FDA has seen it necessary to change Diflucan from a pregnancy category C drug to a pregnancy category D drug. A single dose of Diflucan of 150mg to treat a yeast infection is still considered a category C pregnancy drug.
A pregnancy category D drug means that there has been confirmed evidence of human fetal risk based on data from human studies.
Some of the rare birth defects being documented in infants of mothers who took large dosages of Diflucan during the first trimester may include:
- A short, broad head
- Abnormal looking face
- Oral cleft (cleft palate)
- Bowing of the thigh bones
- Thin ribs and long bones
- Muscle weakness and joint deformity
- Congenital (present at birth) heart disease
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