The FDA has reclassified the antifungal medication, Diflucan (generic: Fluconazole), as a Category D drug because recent case studies have found evidence the medication causes rare and distinct birth defects in children born to women who took chronic and high doses of the drug during the first trimester of pregnancy.
Diflucan Birth Defects Lawsuit Review: If you or somebody you know has a child that has been diagnosed with a birth defect related to Diflucan, you should contact our lawyers immediately. Consultations are always free. Please use our confidential email contact form or call toll free 24 hrs/day by dialing (866) 588-0600.
What Birth Defects Are Linked to Diflucan?
When exposed to a long-term, high-dose of Diflucan or fluconazole during pregnancy, infants display birth defect features including:
- 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 deformities)
- Congenital heart disease (heart conditions present at birth)
Marketed by Pfizer Inc., Diflucan (fluconazole) was FDA approved in January 1990 as an antifungal antibiotic. It belongs to a group of drugs known as Azole antifungals, which are divided into two groups: triazoles and imidazoles. Diflucan is used to treat the following conditions:
- Yeast infections of the vagina, mouth, throat, esophagus and other organs.
- Meningitis caused by certain types of fungus.
- To prevent infections in patients who are likely to become infected because they are being treated with chemotherapy or radiation therapy before a bone marrow transplant.
However, in August 2011, the FDA issued a Drug Safety Communication advising the public that chronic, high doses (400-800 mg/day) of the antifungal drug Diflucan may be associated with rare, but distinct birth defects in infants whose mothers took the drug during the first trimester of pregnancy. These birth defects include abnormalities in skeletal and muscle structure, and heart defects.
According to the FDA, there have been several case reports of birth defects in infants whose mothers took Diflucan at high doses for serious and life-threatening fungal infections during the first trimester.
Based upon these findings, the FDA has reclassified Diflucan as a Category D drug, meaning there is positive evidence from both animal and human study suggesting a human fetus is at risk.
If you or someone you know took Diflucan during pregnancy and gave birth to a baby with birth defects, you may want to contact a Diflucan lawyer or attorney with our firm to discuss the potential for a Diflucan birth defects lawsuit.
The FDA has received several reports of rare, but distinct birth defects associated with mothers who were treated with chronic high-dose (400-800 mg/day) fluconazole for fungal infections in the first trimester of pregnancy.
According to a Drug Safety Communication released by the FDA on August 3, 2011:
“Four reports involved maternal use of chronic high-dose intravenous 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.”
All of the reported birth defects shared characteristics with an autosomal recessive genetic disorder known as Antley-Bixler syndrome, which occurs rarely in the general population. Antley-Bixler is a severe disorder characterized by malformations and deformities in the majority of the skeleton and other areas of the body.
The available data, the FDA says, does not suggest an association between low-dose oral fluconazole use in the first trimester of pregnancy and birth defects. Patients who received a single oral dose of 150 mg for conditions like vaginal yeast infections showed no pattern of birth defects.
Diflucan Case Studies
One case study involved an infant girl who was born prematurely to a woman who underwent fluconazole (400 mg/day) treatment throughout pregnancy. The baby girl was born with:
- Cranioschisis of the frontal bones (failure of the 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 the 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 infant died shortly after birth. There were also additional cases reporting birth defects similar to those that occurred in this baby. The birth defects included craniofacial, skeletal and cardiac malformations. Only one infant survived.
Is there a time limit in filing a Diflucan birth defects lawsuit?
Although we encourage all our potential clients to take great care in selecting their Diflucan lawyer, it is important that you understand that time is of the essence. The applicable statute of limitations in your state may time bar your claim. Furthermore, we are unable to provide you with legal advice without first evaluating your potential case. Accordingly, please take the time now to contact us by using the confidential email contact form below or by calling us toll free 24 hrs/day by dialing (866) 588-0600.
We hope we will be able to assist you with your potential Diflucan birth defects lawsuit and look forward to speaking with you.
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