Drugs.com describes fluconazole as the first of a new subclass of synthetic triazole antifungal agents, which is available as tablets for oral administration, as a powder for oral suspension, and as a sterile solution for intravenous use in Viaflex® Plus plastic containers. Fluconazole is indicated for the treatment vaginal candidiasis, oropharyngeal and esophageal candidiasis and cryptococcal meningitis. Fluconazole is also used prevent yeast infection in patients undergoing chemo- or radiation therapy prior to a bone marrow transplant.
Cole Petrochko, an associate staff writer for MedPage Today, has reported "Drug to Treat Fungal Infections Linked to Birth Defects." New labelling has been ordered by the FDA for fluconazole (Diflucan), with a warning that multiple, high doses of the antifungal by pregnant women may increase the risk of birth defects. The FDA has released a statement saying the risk is seen with daily doses of 400 mg to 800 mg used during most or all of the first three months of pregnancy.
The FDA has gone on to say that the birth defects which are "related to the drug in infants include brachycephaly, abnormal facies, abnormal development of the skullcap, cleft lip or palate, femoral bowing, thin ribs and long bones, arthrogryposis -- a rare disorder characterized by joint contractures, muscle weakness and fibrosis -- and congenital heart disease." According to the statement a low single dose in the range of 150 mg to treat yeast infection during pregnancy appears to be safe.
Aside from the label change the FDA has raised fluconazole from pregnancy category C to category D for all but single, low-dose candidiasis indications. There is "positive evidence of human fetal risk based on human data" for drugs listed as category D. Any drugs listed in category D should be used in pregnant women only in cases of serious or life-threatening conditions where the benefits outweigh the risks. Drugs listed in category C show fetal risk in animal studies, however, they have no adequate data for human patients.
Photographer: Carlos Porto
