Diflucan Birth Defects Injury Lawsuits. If you were treated with Diflucan (fluconazole) during the first trimester of pregnancy and your child was born with a birth defect, the defective drug attorneys at Parker Waichman LLP would like to speak with you.
High dose therapy with Diflucan to treat life-threatening yeast and fungal infections during early pregnancy has been associated with certain rare birth defects, including brachycephaly, facial abnormalities, abnormal skull cap development, cleft palate, thigh(femur) bowing, thin ribs and long bones, muscle weakness, joint defects, and congenital heart disease. The U.S. Food & Drug Administration (FDA) issued a warning about Diflucan birth defects in August 2011, and moved high-dose versions of the drug into a more serious pregnancy risk category.
If your child was born with a congenital abnormality and you were treated with high-dose Diflucan while pregnant, you may be eligible to file a Diflucan birth defect lawsuit. The Diflucan birth defect lawyers at Parker Waichman LLP are currently offering free lawsuit evaluations to all victims of this defective drug. To learn how our firm can help you and your child obtain compensation, we urge you to contact our Diflucan birth defect lawyers today by completing our online form or call Parker Waichman LLP at 1-800-YOURLAWYER(1-800-968-7529).
Diflucan Birth Defects, FDA Drug Safety Communication
Diflucan is used to treat vaginal yeast infections, in addition to yeast infections of the mouth, throat, esophagus and other organs. Diflucan is also used to prevent yeast and fungal infections in patients being treated with chemotherapy or radiation therapy before bone marrow transplant, and is also used to treat meningitis caused by a certain type of fungus.
In August 2011, the FDA issued a Drug Safety Communication warning that several case reports in the medical literature had linked chronic use of high-dose (400-800 mg/day) Diflucan to a rare and distinct set of birth defects in infants whose mothers were treated with the drug during the first trimester of pregnancy.
Four reports involved maternal use of chronic high-dose intravenous Diflucan for coccidioidal meningitis, and one report involved a human immunodeficiency virus (HIV)-positive mother who received chronic high-dose oral fluconazole for a vaginal yeast infection. These reports prompted the FDA to move this Diflucan indication 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. The Pregnancy Category for 150 mg Diflucan used to treat vaginal yeast infections was not changed, and remains Category C, the FDA said.
Birth defects possibly associated with high-dose Diflucan therapy include:
- Brachycephaly: A failure of the cranial sutures to fuse properly which results in malformations in the head and the inability for it to grow along with the brain.
- Abnormal facies: Facial abnormalities.
- Abnormal calvarial development: Abnormal development of the skull cap.
- Cleft palate: Birth defects in which the tissues of the mouth or lip don’t form properly during fetal development.
- Femoral bowing: A malformation of the thigh bone.
- Thin ribs and long bones.
- Arthrogryposis: Muscle weakness and joint deformities.
- Congenital heart disease: Heart conditions present at birth.