IMA Advisory: Alert on use of sodium valproate in pregnant women

IMA Advisory: Alert on use of sodium valproate in pregnant women These five congenital anomalies could have been saved Dear Colleague Sodium valproate in pregnant women is widely prescribed by the clinicians of many hospitals, which is a matter of great concern as this drug belongs to pregnancy category D (There is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.). A total of 5 individual case safety reports have been reported in the NCC-PvPI database. These children born were identified to have congenital anomaly after receiving sodium valproate by their mothers during pregnancy. Kindly DO NOT PRESCRIBE sodium valproate in pregnancy. Report immediately at 9717776514 if such issues are identified with the use of sodium valproate for further actions. Dr KK Aggarwal National President IMA (Contributions from Dr V Kalaiselvan, Principal Scientific Officer, NCC-PvPI, Indian Pharmacopoeia Commission)