NORMALISED TOXICITY TO PREGABALIN DID NOT INCREASE WITH CHANGES IN APPROVAL MECHANISM AND USE IN AUSTRALIA

Abstract

Background: Pregabalin is a potent antagonist of neuronal voltage-gated calcium channels used to treat neuropathic pain. Although first registered with the Therapeutic Goods Administration (TGA) in April 2005, rapid uptake of pregabalin in the Australian market only came after its listing on the Pharmaceutical Benefits Scheme (PBS) with a streamlined code on 1st March 2013 for the indication of neuropathic pain. Recently, there has been concern raised about the growing off-label use of pregabalin for chronic pain syndromes and the subsequent potential for undue adverse drug reactions (ADRs).1 Objectives: The aim of this study was to measure how broadening access to pregabalin in Australia af..