Proposed changes to Required Advisory Statements for Medicine Labels (RASML): Sedating antihistamines

Results updated 16 Nov 2021

Introduction

We asked for comments from interested parties on changes to current requirements for advisory statements for labels of non-prescription medicines containing antihistamines indicated for short term use in insomnia (diphenhydramine, doxylamine and promethazine), as included in the Required Advisory Statements for Medicine Labels (RASML) document. Proposed changes involved deletion of pregnancy warnings for doxylamine and diphenhydramine and simplification of breastfeeding warnings for antihistamines used for insomnia.

Summary and discussion of responses

The TGA would like to thank those who responded to the consultation. We received 7 submissions. All submissions supported the proposed changes, although one submission suggested more stringent warnings in relation to use when breastfeeding. The TGA considers that the proposed warning to consult a doctor or pharmacist regarding use of antihistamines for insomnia when breastfeeding is sufficient and note that a warning regarding potential sedation is required for all sedating antihistamines. One submission suggested a change to the wording of age restrictions in the existing entries. The TGA notes that the current wording of age restrictions is consistent throughout RASML and considers that the current wording is appropriate.

Outcome

The TGA will include the proposed changes in the next update of the RASML, to occur in late 2021 or early 2022.

Published responses

View submitted responses where consent has been given to publish the response.