Sandoz and Novartis: Warning about small increased risk of oral clefts following use in the first 12 weeks of pregnancy

Sandoz and Novartis: Warning about small increased risk of oral clefts following use in the first 12 weeks of pregnancy

In collaboration with the South African Health Products Regulatory Authority (SAHPRA), the below listed companies would like to inform you of an increased risk of cleft lip and/or cleft palate following the use of ZOFRAN® (ondansetron) during the first 12 weeks of pregnancy.

2020 Jun

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Document Number: DHCPL
Version: 1
Date Updated: 12/06/2020
File Type: pdf
Category: Communication To Health Care Professionals
Unit: Pharmacovigilance