Diflucan May Be Related To Increased Risk of Congenital Heart Defects in Children
This week, the New England Journal of Medicine published Danish Researchers’ findings on whether low doses of Diflucan (a Pfizer medication) carry the same risk of birth defects that long term, high doses of the medication have seen, as referenced here.
In August of 2011, the FDA changed the designation of high doses Diflucan from a Category C to a Category D pregnancy drug, which means that there is positive human evidence of a risk of birth defects and issued a drug safety communication about the change. The categories for single and low doses of the drug were not changed by the FDA at that time.
According to the FDA, case studies showed that long-term, high doses of Diflucan taken in the first trimester of pregnancy caused many different birth defects such as abnormal head, skull and face defects, cleft palate, joint deformities and congenital heart disease at birth.
The latest study isolated 15 specific type of birth defects and conducted a registry-based cohort study of live born infants in Denmark, which compared Diflucan use in the first trimester and the rate of birth defects. The results determined that overall, Diflucan exposure was not associated with an increased risk of birth defects, except for two: tetralogy of Fallot (a congenital defect which also affects the heart and is the most common cause of blue baby syndrome) and congenital heart defect. Specifically, it was shown that congenital heart defects occurred in one out of every 1,000 cases of first trimester Diflucan exposure compared to 3 out of every 10,000 occurrences in other pregnancies.
The manufacturer as well as the scientific community need to assess the reliability and validity of this cohort study to determine what, if any, scientific value it may offer for proving that Diflucan at the levels studied causes the specific birth defects that the study suggests are associated with its use in the first trimester. The study results will likely be evaluated by FDA, and questions about the reliability of the study results for concluding causation will certainly be considered by the Agency. Lastly, from a litigation perspective, future claimants will scrutinize how Pfizer responds to this scientific development, especially if the product is left on the market. Making a record now that Pfizer seriously considered the issue and responded as a prudent and responsible manufacturer will be important should it be defending its conduct in future personal injury lawsuits.
The New England Journal of Medicine article is available, click here. Please note the article is available only with a subscription.