Pregnant women using ongoing, big doses of the pharmaceutical fluconazole (brand name Diflucan) may run an increased risk of having children with birth defects, according to a new warning issued by the U.S. Food and Drug Administration (FDA).
Fluconazole is used to treat a variety of yeast infections, pertaining to the mouth, throat, vagina, and other areas, and associated with oropharyngeal and esophageal candidiasis, vaginal candidiasis, and cryptococcal meningitis. It’s also prescribed for its anti-fungal purposes to individuals undergoing radiation therapy and chemotherapy prior to a bone marrow transplant, and to those suffering meningitis due to a particular strain of yeast infection.
The FDA mandated additional product labeling and listed harmful doses of the medicine as 400 and 800 milligrams taken daily during an expecting woman’s first trimester (the first three months of pregnancy). No advisory has been given by the FDA for using low, single doses (150 milligrams or less) to treat vaginal yeast infections.
Birth defects associated with the product, according to the FDA, may include: “abnormal facies, femoral bowing, abnormal development of the skullcap, brachycephaly, cleft lip or palate, thin ribs and long bones, congenital heart disease, and arthrogryposis.”
In addition to the increase in product labeling, with regard to the FDA’s classifications on fetal hazards due to pharmaceutical use, fluconazole’s official rating has been elevated from a category C to a category D (with the exception of low dose, short term usage). Category D claims evidence that a particular drug may be dangerous to human fetuses, while the drug’s prospective medical benefits in treating substantial or life-threatening sickness in expecting women may warrant use in some occasions, regardless of possible risks, according to the FDA.
If you’ve become pregnant while using fluconazole, have taken the drug while expecting, or have suffered ill reactions due to the drug, you may be entitled to compensation for your damages. Consult an experienced Philadelphia drug injury attorney today to learn more about your rights.