MADRAC Bulletin - Issue 03/2017

Safety Issues Presented to MADRAC in 2017

Regulatory Matters

▪ Fluconazole: Risk of Spontaneous Abortion and Multiple Congenital Abnormalities
▪ Tramadol: Restricted Use in Children and Warnings of Use in Pregnant and Breastfeeding Women
▪ Metformin: Use in Patients with Moderately Reduced Kidney Function
▪ Metronidazole: Risk of Hepatotoxicity in Patients with Cockayne Syndrome
▪ Aripiprazole: Risk of Pathological Gambling and Impulse-Control Problems

ADR Reporting

▪ CPD Points for Quality ADR Reporting