Dear Doctor Letter (Rote-Hand-Brief) on ondansetron: increased risk of orofacial malformations when used in the first trimester of pregnancy
2019.10.01
Active substance: ondansetron
In coordination with the Federal Institute for Drugs and Medical Devices (BfArM), the marketing authorisation holders of drugs containing ondansetron inform about new findings in connection with the use of ondansetron during pregnancy. It is suspected that ondansetron causes orofacial malformations when administered in the first trimester of pregnancy.
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