Diflucan (fluconazole) is intended to assist in the treatment and prevention of fungal infections. More specifically, it is an anti-fungal antibiotic often used to treat yeast infections of the vagina, mouth, throat, esophagus and other organs. Amidst growing concerns over the safety of Diflucan during pregnancy, researchers believe that the antibiotic may be responsible for a rare and distinct set of birth defects in infants.
If you or a loved one has given birth to a child with birth defects that you feel may be the result of taking Diflucan, you should contact our lawyers immediately for a free confidential case evaluation. You may be entitled to compensation for your injuries and we can help.
Diflucan Lawsuit Overview
As a product of the pharmaceutical goliath Pfizer, Diflucan was developed on January 29, 1990. After gaining the approval of the U.S. Food and Drug Administration (FDA), Diflucan quickly became a significant component in the fight against numerous variations of fungal infection. It served as the first in a new subclass of synthetic triazole anti-fungal agents that utilize fluconazole as an active ingredient. Fluconazole is available as tablets for oral administration, as a powder for oral suspension, and as a sterile solution for intravenous applications.
Fluconazole is a highly selective inhibitor of fungal cytochrome P450 dependent enzyme lanosterol 14-α-demethylase. This enzyme assists in the conversion of lanosterol to ergosterol. As a result, the subsequent loss of normal sterols correlates with the accumulation of 14-α-methyl sterols, and may be responsible for inhibiting the growth of harmful fungi.
Unfortunately, Diflucan appears to readily come in contact with the placenta, and serious concerns have surfaced regarding the administering of fluconazole during pregnancy. Despite the ability to fight fungal infections, pregnant women who receive prolonged Diflucan treatment may significantly increase the risk of their child developing a rare and distinct set of birth defects. Due to the severity of congenital birth defects, patients may contact a Diflucan lawyer at The Senators (Ret.) Firm, LLP for a free case evaluation of their potential Diflucan lawsuit.
Diflucan Side Effects
Pregnant women who undergo Diflucan treatment may significantly increase the risk of their child developing the following birth defects:
- Multiple synostosis
- Digital Synostosis
- Congenital heart defects
- Skeletal anomalies
- Dysmorphic facial features (cleft lip and cleft palate)
- Abnormal facies
- Abnormal calvarial development
- Femoral bowing
Due to the severity of these congenital birth defects, families may contact a Diflucan lawyer at The Senators (Ret.) Firm, LLP for a free case evaluation of their potential Diflucan lawsuit.
Diflucan Birth Defects
Despite the advantages Diflucan displays in the treatment of fungal infection, it may not demonstrate a favorable risk-benefit profile. Researchers believe that the mechanism regarding the association between Diflucan and congenital birth defects may be directly related to the pharmacodynamics of fluconazole.
Documented reports indicate that a woman, after receiving fluconazole 400 mg per day throughout her pregnancy, prematurely gave birth to an infant that displayed a distinct set of congenital birth defects. The infant was diagnosed with cranioschisis of the frontal bones, craniostenosis of the sagittal suture, hypoplasia of the nasal bones, cleft palate, humoral-radial fusion, bowed tibia and femur, bilateral femoral fractures, contractures of both upper and lower extremities, and defects of the fingers and toes. Tragically, the infant died only weeks after being born.
Additional cases of congenital malformations have been reported in infants born to women receiving fluconazole during or beyond the first trimester of pregnancy. Craniofacial, skeletal and cardiac malformations were evident in each case. Due to the severity of congenital birth defects, patients may contact a Diflucan lawyer at The Senators (Ret.) Firm, LLP for a free case evaluation of their potential Diflucan lawsuit.
FDA Diflucan Warning
The following FDA Safety Alert acknowledges the dangers associated with pregnant women receiving Diflucan treatment:
The FDA has informed the public that treatment with chronic, high doses (400-800mg/day) of Diflucan (fluconazole) during the first trimester of pregnancy may be associated with a rare and distinct set of birth defects in infants. Based on this information, the pregnancy category for fluconazole indications has been changed from category C to category D. In doing so, the FDA is acknowledging that there is substantial evidence that Diflucan may be responsible for severe, life-threatening birth defects.
A few published case reports describe a rare pattern of distinct congenital anomalies in infants exposed, in utero, to high dose maternal fluconazole (400-800 mg/day) during most or all of the first trimester. Recent studies describe a distinctive and rare pattern of birth defects among infants whose mothers received high-dose (400-800 mg/day) fluconazole during most or all of the first trimester of pregnancy. The features seen in these infants include: brachycephaly, abnormal facies, abnormal calvarial development, cleft palate, femoral bowing, thin ribs and long bones, arthrogryposis, and congenital heart disease. Due to the severity of these congenital birth defects, patients may contact a Diflucan lawyer at The Senators (Ret.) Firm, LLP for a free case evaluation of their potential Diflucan lawsuit.
Do I Have a Diflucan Lawsuit?
The trial lawyers at The Senators (Ret.) Firm, LLP have decades of experience navigating through complex legislative and regulatory issues and litigating high stakes cases all over the nation. Our law firm focuses on the representation of plaintiffs in Diflucan lawsuits. We are currently accepting new cases in all 50 states.
Again, If you or a loved one has given birth to a child with birth defects that you feel may be the result of taking Diflucan, you should contact our lawyers immediately by clicking the link below or calling toll free 1-(949) 557-5800. You may be entitled to compensation for your injuries and we can help.