ERBs Palsy Birth Defects

The U.S. Food and Drug Administration has issued an advisory to the public warning that mothers-to-be who take high doses of an antifungal drug during their first trimester of pregnancy may be increasing their risk of giving birth to a child with a specific set of birth injuries.

Diflucan (or fluconazole) is an antifungal drug that is used by women to treat a number of fungal infections in the mouth, throat, esophagus as well as vaginal candidiasis. However, a number of published case studies have shown that pregnant women who take high doses of the drug (approximately 400-800 mg/day) during their first trimester increase the risk of a number of birth injuries and malformations.

Some of these birth complications include an abnormal development of the skull cap and other facial features, congenital heart disease, joint deformities and muscle weakness, oral cleft, and thin ribs.

Based on this data, the FDA announced this week that is was adjusting Diflucan from a Category C to Category D pregnancy drug. According to the agency, a Category D drug indicates that there is “positive evidence of human fetal risk based on human data but the potential benefits from use of the drug in pregnant women with serious or life-threatening conditions may be acceptable despite its risks.”

The FDA added that patients should immediately notify their healthcare professional if they become pregnant while taking fluconazole.

If you or a loved one took fluconazole while pregnant and proceeded to give birth to a child with birth complications similar to the ones listed above, you may have grounds to pursue a childbirth injury lawsuit against the doctors involved in the birth. Speak to a birth injury attorney at Sokolove Law today to learn more about your legal options.

Birth Injury