In August 2019, the European Medicines Agency (EMA) Pharmacovigilance Risk Assessment Committee (PRAC) recommended that all marketing authorisation holders for ondansetron containing medicines, update their product literature to state ondansetron containing medicines should not be used in the first trimester of pregnancy.
In response to EMA PRAC recommendations; UKTIS have prepared a response statement which states that, although findings of the study identifying associations with cleft lip and/or palate appear robust, absolute increase in risk of orofacial cleft following first trimester maternal ondansetron use was very small, affecting approximately 14 per 10,000 births, compared to a background rate of 11 per 10,000 unexposed pregnancies. This equates to three additional cases of orofacial cleft per 10,000 women using ondansetron during first trimester.
For these reasons UKTIS and the European Network of Teratology Information Services (ENTIS) do not support the recommendations made by EMA PRAC; stating they believe this would result in less effective control of maternal nausea and vomiting, increased maternal morbidity and hospitalisation, and an increased risk of termination of wanted pregnancies.