August 3, 2011 — Long term and high dose use of the antifungal medication Diflucan (fluconazole) may cause a rare and distinct set of birth defects in infants born to mothers who were treated with the drug during the first trimester of pregnancy.

What You Can Do & How We Can Help

The Schmidt Firm, LLP is currently accepting Diflucan birth defects cases in all 50 states. If you or somebody you know used Diflucan during pregnancy and gave birth to an infant with birth defects, you should contact our lawyers immediately for a free case consultation. Please use the form below to contact our Dangerous Drug Litigation Group or call toll free 24 hours a day at (866) 920-0753.

Diflucan: An Overview

Diflucan and (fluconazole) is an antifungal drug marketed by Pfizer Inc. It is used to treat infections caused by fungus, which can invade the mouth, throat, esophagus, lungs, bladder, genital area and blood.  FDA approved in January 1990, it is also used to prevent fungal infections in people with weakened immune systems due to cancer treatment, bone marrow transplant or diseases like AIDS.

Recently, the FDA warned the public that chronic, high doses (400-800 mg/day) of Diflucan during the first trimester of pregnancy may cause a rare and distinct set of birth defects in infants. The birth defect features include abnormally shaped head and face, cleft lip or palate, bowing of the thigh bones, thin ribs and long bones, muscle weakness and joint deformities, and congenital (present at birth) heart disease.

Due to Diflucan’s association with birth defects, the FDA has reclassified the drug from a Category C to a Category D drug, meaning there is positive evidence from human and animal studies suggesting a human fetus is at risk. The pregnancy category for a single, low dose of fluconazole has not been changed and remains a Category C, as the risk of birth defects is not associated with low doses (150 mg) of fluconazole used to treat conditions like vaginal yeast infections.

However, the risks associated with chronic, high dose Diflucan are serious and could be life-threatening to a baby.

If you or someone you know took Diflucan while pregnant and gave birth to an infant with birth defects, you may want to contact a Diflucan lawyer or attorney with The Schmidt Firm, LLP to discuss the potential for a Diflucan lawsuit.

Diflucan Birth Defects

The following birth defects have been associated with babies born to mothers who took Diflucan (fluconazole) during the first trimester of pregnancy:

• Brachycephaly (short, broad head)
• Abnormal facies (abnormal looking face)
• Abnormal calvarial development (abnormal development of the skullcap)
• Cleft palate (opening in the lip or palate)
• Femoral bowing (bowing of the thigh bones)
• Thin ribs
• Long bones
• Arthrogryposis (muscle weakness and joint deformity)
• Congenital heart disease (heart conditions present at birth)

FDA Warning

According to an August 3, 2011 warning by FDA, there are several published case reports describing rare and distinct birth defects in infants whose mothers took chronic high-dose (400-800 mg/day) fluconazole or Diflucan therapy for fungal infections during the first trimester for pregnancy.

Said the FDA:

“Four reports involved maternal use of chronic high-dose intravenuous fluconazole for coccidioidal meningitis and one report involved a human immunodeficiency virus (HIV)-positive mother who received chronic high-dose oral fluconazole for vaginal candidiasis (yeast infection).”

The infants born with birth defects all displayed symptoms similar to Antley-Bixler syndrome, a rare and severe disorder characterized by malformations and deformities of the majority of the skeleton and other areas of the body.

The data do not suggest an association between low-dose fluconazole and birth defects.

Because of the birth defect risk associated with chronic high-dose Diflucan use during the first trimester of pregnancy, the FDA recommends healthcare professionals should be aware of the potential risks with long-term, high-dose use of fluconazole and counsel patients if the drug is used during pregnancy or if a patient becomes pregnant while taking the drugs. Patients are encouraged to notify their doctor if they are pregnant or become pregnant while taking fluconazole.

Diflucan Treatments

Diflucan is used to treat the following conditions:

• Yeast infections of the vagina, mouth, throat esophagus and other organs.
• Meningitis caused by a certain type of fungus.
• Prevent yeast infections in patients who are likely to become infected because they are being treated with chemotherapy or radiation therapy before bone marrow transplant.

Diflucan Case Study

One infant girl was born prematurely and with severe birth defects to a woman who underwent fluconazole therapy (400 mg/day) throughout her pregnancy. The baby’s birth defects were detailed in a case study. The baby girl was born with:

• Cranioschisis of the frontal bones (failure of some parts of the skull to close)
• Craniostenosis of the sagittal suture (early fusing of some skull bones that causes an abnormal head shape)
• Hypoplasia of nasal bones (underdeveloped nose)
• Cleft palate (opening in the lip or palate)
• Humoral-radial fusion (fusion of arm bones)
• Bowed tibia and femur
• Bilateral femoral fractures
• Contractures of both upper and lower extremities (shortened limbs)
• Defects of the fingers and toes

The baby girl died shortly after birth. Other case studies outline other infants born with similar birth defects as the baby girl. The birth defects included craniofacial, skeletal and cardiac malformations. Of all the infants studied, only one infant survived.

Do I Have a Diflucan Lawsuit?

The Schmidt Firm, LLP is currently accepting Diflucan birth defects cases in all 50 states. If you or somebody you know used Diflucan during pregnancy and gave birth to an infant with birth defects, you should contact our lawyers immediately for a free case consultation. Please use the form below to contact our Dangerous Drug Litigation Group or call toll free 24 hours a day at (866) 920-0753.

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