The antifungal drug Diflucan (fluconazole) may cause rare and distinct birth defects in infants born to mothers who took the medication during the first trimester of pregnancy at chronic, high doses. The risk of birth defects is prompting the FDA to reclassify Diflucan from a Category C to a Category D pregnancy drug.
Do I Have a Diflucan Lawsuit? Collen A. Clark is a true advocate for his clients and is passionate about helping Texans that have been injured or wronged. If you or a loved one have taken Diflucan while pregnant and given birth to a baby with birth defects, you should contact our lawyers immediately. You may be entitled to compensation by filing a Diflucan lawsuit.
Diflucan: An Overview
Manufactured by Pfizer, Inc., Diflucan was FDA approved in January 1990 as an antifungal medication used to treat infections caused by fungus that can invade the mouth, throat, esophagus, lungs, bladder, genital area and blood. It is also used as a medication to prevent fungal infections in people especially susceptible to them due to a weakened immune system caused by cancer treatment, bone marrow transplant or diseases like AIDS.
However, the benefits of Diflucan should be measured against the risks of use, especially in pregnant women.
In August, the FDA found that chronic, high doses (400-800 mg/day) of Diflucan or fluconazole therapy during the first trimester of pregnancy may cause rare but distinct birth defects in children. The defects included an abnormally shaped head or face, cleft lip or palate, bowing of the thigh bones, thin ribs and long bones, muscle weakness and joint deformities, and congenital heart disease.
Due to the risk of birth defects, the FDA is reclassifying Diflucan from a Category C pregnancy drug to a Category D, as research from both human and animal studies suggest fetal risk. Meanwhile, the pregnancy category for a single, low dose of Diflucan or fluconazole treatment has not been changed and remains at a Category C, as the risk of birth defects is not associated with low doses (150 mg) used to treat conditions like vaginal yeast infections.
Diflucan Birth Defects
First-trimester use of Diflucan is associated with the following birth defects:
- 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)
Diflucan can either be administered through an injection or orally, in order to treat:
- 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.
FDA Case Reports
In its August 31, 2011 Drug Safety Communication, the FDA said it had received 5 case reports of mothers who took chronic high-doses (400-800 mg/day) of fluconazole or Diflucan and given birth to infants with rare and distinct birth defects. The mothers were using fluconazole therapy as a way to treat fungal infections during the first trimester of pregnancy.
Four of the case reports involved a mothers with coccidioidal meningitis who were receiving fluconazole injections, the other involved a mother with HIV who was receiving chronic high-dose oral fluconazole for vaginal candidiasis (yeast infection).
The infants born to these mothers all displayed similar birth defects that resembled symptoms of Antley-Bixler syndrome. Antley-Bixler syndrome is a rare and severe disorder characterized by malformations and deformities of the majority of the skeleton and other areas of the body.
As a result of these birth defects, the FDA encouraged doctors to counsel patients if they are thinking of using Diflucan 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 Diflucan.
Diflucan Baby Girl Case Study
In one notable case study, a woman took fluconazole therapy (400mg/day) throughout her pregnancy. She gave birth to an infant girl prematurely and the girl displayed severe birth defects. The birth defect features included:
- 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. Two other case studies outline other infants who were born with defects similar to those found in the baby girl. The birth defects included craniofacial, skeletal and cardiac malformations. Of all three case studies, only one baby survived.
Diflucan Class Action Lawsuit Information
The birth defects associated with Diflucan are extremely serious. They can cause devastating physical disfigurement, pain and suffering, ongoing medical expenses, disability, or even death. Many children require multiple surgeries very early in life. If your child was injured, you may be entitled to compensation for your child’s injury. However, instead of a Diflucan class action lawsuit, our trial attorneys are filing individual lawsuits.
Do I Have a Diflucan Lawsuit?
Collen A. Clark is a true advocate for his clients and is passionate about helping Texans that have been injured or wronged.
Collen’s amazing success in the courtroom and well known dedication to his clients has earned him the recognition of his peers as one of The Top Trial Lawyers in Texas.”
The Clark Firm has assembled a team of trial lawyers with more than 100 years experience, participation in over 600 jury trials and $60 million in verdicts and/or settlements. Please use the form below to contact us for a free Diflucan lawsuit review or you may also call us directly by dialing (866) 879-3040.