MHRA: Ondansetron small increased risk of oral clefts following use in the first 12 weeks of pregnancy

MHRA (Medicines & Healthcare products Regulatory Agency)  has recently published a warning regarding the use of ondasetron in early pregnancy.leading to a small but significant risk of cleft lip. – LINK HERE

Recent epidemiological studies report a small increased risk of orofacial malformations in babies born to women who used ondansetron in early pregnancy.1 4 Key evidence was an observational study of 1.8 million pregnancies in the USA of which 88,467 (4.9%) were exposed to oral ondansetron during the first trimester of pregnancy. The study reported that ondansetron use was associated with an additional 3 oral clefts per 10,000 births (14 cases per 10,000 births versus 11 cases per 10,000 births in the unexposed population).1 These data were recently reviewed within Europe and considered to be robust.

Patients with vomiting in early pregnancy requiring antiemetics you can review the guidance on “Hyperemesis Gravidarum”

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