Multiple mothers prescribed the antidepressant sertraline hydrochloride, also branded as Zoloft, gave birth to infants with a myriad of congenital defects. Each woman’s physician had thought it important that the mothers maintain their use of antidepressants while pregnant. However, the newborns exhibited signs of craniosynostosis in irregular skull growth patterns, bilateral clubfeet, and gastroschisis, where the child’s intestines and liver protruded out of their belly button. Consequently, the manufacturing company of Zoloft was named in a lawsuit, and the trial needed an expert in perinatal epidemiology to comment on the link between congenital defects and SSRI reuptake inhibitors like Zoloft.
Question(s) For Expert Witness
1. What is your experience of congenital birth defects due to maternal Zoloft use?
2. What is the incidence and prevalence of these incidents?
Expert Witness Response E-019354
As an expert in Pharmacovigilance, I can evaluate any case of adverse drug reactions to establish a potential relationship. I have reviewed the medical literature about the problem of SSRI-induced congenital malformations; the incidence of these cases are impossible to assess. All available studies are biased and probably underestimate the problem. Any case of malformation could be associated to many factors other than drug therapies, so establishing a causal association is very difficult. There are several degrees of probability using specific algorithms, but a definite association is almost improbable.
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