ST. PETE BEACH, FLA. — Diclectin used for nausea and vomiting of pregnancy does not appear to affect the later neurocognitive development of children who are exposed to the drug in utero, Irena Nulman, M.D., and her colleagues at the Hospital for Sick Children, Toronto, reported at the annual meeting of the Teratology Society.
The drug, available in Canada but not in the United States at this time, has proved safe in terms of fetal dysmorphology, but its effects on the developing central nervous system have been unclear, the investigators reported in a poster at the meeting.
In a prospective, randomized, double-blind study, they examined children's neurocognitive development and measures of child behavior and language development. The study included 42 mother-child pairs exposed to nausea and vomiting of pregnancy (NVP) and diclectin, 37 pairs exposed to NVP but not to pharmacotherapy, and 25 pairs not exposed to NVP.
Groups did not differ significantly in any of these measures. Children in all groups had scores in the normal range on total indexes of IQ and on measures of temperament, behavior, and language. For example, performance IQ scores were a mean of 119.76 in the NVP/diclectin-exposed group, 111.75 in the NVP-only group, and 110.08 in the unexposed group.
“Exposure to diclectin does not adversely affect child long-term full-scale IQ. … When indicated, diclectin therapy should be instituted to prevent hyperemesis gravid[ar]um and improve pregnant women's life style,” they concluded.
Diclectin, manufactured by Duchesnay Inc., is a generic form of the drug Bendectin, which was marketed in the United States until 1983 when it was voluntarily withdrawn by its manufacturer, Merrell Dow Pharmaceuticals Inc., following a series of lawsuits claiming the drug caused birth defects. The company won every case and numerous studies have confirmed the drug's safety. Duchesnay Inc. is seeking FDA clearance to market the drug here.