A to X: the problem of categorisation of drugs in pregnancy — an Australian perspective

To the Editor: As an author, researcher and lecturer on the safety of drugs used in the obstetric setting for over 30 years — during which I participated in successive Medicines in Pregnancy Working Parties of the Australian Drug Evaluation Committee and Therapeutic Goods Administration (TGA) — I share Kennedy’s concerns about the alphabetical drug categorisation system currently used in Australia.1 I am also concerned that, since the demise in 2008 of the Prescribing Medicines in Pregnancy TGA Advisory Group (which provided ongoing external clinical expertise to the TGA), there has been a complete lack of action, preparation and consultation with external sources of expertise and experience by the TGA with regard to the safety of drugs used in pregnancy. Expert consultation would be invaluable in preparing for the overseas “game-changing” developments in labelling relating to safety of drugs used during pregnancy, as identified by Kennedy. These changes in labelling are primarily being driven in the United States, with the aim of providing definitive, well substantiated advice to patients and health professionals — advice that reflects the consensus of expert opinion in a way that the alphabetical system, by its inherent structural and functional limitations, is unable to do.