The antifungal drug fluconazole—sold under the brand names Diflucan and Trican—has been identified as a potential cause of disfiguring birth defects.
What Is Diflucan? When Is It Prescribed?
Diflucan is the brand name for the drug fluconazole. Made and sold by American pharmaceutical giant Pfizer, this prescription medication is used to treat infections caused by the fungal genus Candida, a type of yeast. Specific infections include: vaginal yeast infections; oropharyngeal and esophageal yeast infections; and cryptococcal meningitis. The U.S. Food and Drug Administration (FDA) first approved Diflucan in 1990, and Pfizer sells it in 50 mg to 200 mg oral tablets and as an oral suspension dosed at 50 mg/5 mL to 200 mg /5 mL.
Fluconazole inhibits an enzyme called “fungal cytochrome P450 enzyme lanosterol 14-alpha-demethylase.” This enzyme converts lanosterol into ergosterol. Ergosterol serves fungi as a component of their cell membranes. Without it, they cannot function. Moreover, animals and plants do not need lanosterol, and instead they use cholesterol in their cell membranes. This makes Diflucan especially effective against fungi.
Diflucan Side Effects Include Birth Defects
In August 2011, the FDA issued a Diflucan warning in the form of a Drug Safety Communication. The agency had reviewed several studies and found that long-term use of high doses of Diflucan during the first three months of pregnancy can cause the following birth defects:
- cranial defects (short, broad heads, also called brachycephaly)
- abnormal facial features
- abnormal skull developments
- oral clefts (cleft lip or palate)
- bowed thigh bones
- unusually thin ribs and long bones
- muscle weakness
- joint deformities
- congenital heart disease
The FDA determined that Diflucan doses between 400-800 mg per day caused the above defects. It noted, however, that the normal low dose of 150 mg per day meant to treat vaginal yeast infections did not appear to contribute to a higher incidence of birth defects. As a result of these studies, the FDA changed Diflucan’s pregnancy category from C to D for all uses other than vaginal yeast infections. Pregnancy category D is the second most severe category (above category X), and it means that scientific evidence proves that the drug can cause birth defects in pregnant women but that the benefits of the drug still outweigh its risks. The FDA admits it still does not know full risks Diflucan places on pregnant women. The FDA-mandated Diflucan drug label contains a pregnancy entry in its “Warnings and Precautions” section listing the possibility of these defects.
RLG’s Lawyers Will Make Things Easier
The process of demanding compensation for the harm you’ve suffered can be complicated, even if it doesn’t seem fair that you should have to go through even more trouble to be made whole again. The lawyers of the Rottenstein Law Group believe that getting satisfaction shouldn’t be just more hardship. That’s why we do everything we can to streamline the process of helping victims get the compensation they deserve.
If you’ve taken Diflucan and you believe that you or your child have experienced adverse side effects as a result, contact RLG today.