其 他 安 全 警 示
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| Singapore: Use of Zofran®, Ondansetron Hexal®, Ondansetron Sandoz® (ondansetron) in early pregnancy and risk of birth defects (English only) |
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Health Sciences Authority (HSA) announces that a Dear Healthcare Professional Letter has been issued by Novartis to inform healthcare professionals of the findings from recently published epidemiological studies related to the risk of birth defects associated with ondansetron.
These studies assessed the risk of specific congenital anomalies, including orofacial clefts and cardiac malformations in children born to mothers exposed to ondansetron during the first trimester of pregnancy. An increase in orofacial clefts was observed in infants of women administered ondansetron during the first trimester of pregnancy. Regarding cardiac malformations, the epidemiological studies showed conflicting results.
Healthcare professionals are advised to take into consideration the above safety information when prescribing Zofran®, Ondansetron Hexal® or Ondansetron Sandoz®. These products are not approved for the treatment of nausea and vomiting in pregnancy, and their use in pregnancy is not recommended. Women of childbearing potential should be advised to use contraception while taking Zofran®, Ondansetron Hexal® or Ondansetron Sandoz® and for 2 days after stopping treatment.
Please refer to the following website in HSA for details:
http://www.hsa.gov.sg/announcements/dear-healthcare-professional-letter/use-of-zofran-ondansetron-hexal-ondansetron-sandoz-in-early-pregnancy-and-risk-of-birth-defects
In Hong Kong, there are 32 registered pharmaceutical products containing ondansetron. All products are prescription-only medicines. So far, the Department of Health (DH) has received 3 cases of adverse drug reaction related to ondansetron, but these cases are not related to orofacial clefts in infants of women administered ondansetron during the first trimester of pregnancy. Related news was previously issued by the United Kingdom Medicines and Healthcare products Regulatory Agency and Singapore HSA, and was posted on the Drug Office website on 29 Jan 2020 and 19 Sep 2020. Letters to inform local healthcare professionals were issued by DH on 29 Jan 2020. The DH will remain vigilant on safety update of the drug issued by other overseas drug regulatory authorities.
Ends/Tuesday, Sep 29, 2020
Issued at HKT 15:00
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