Faa use of sedating antihistamines dating scribd
Invitation to comment | Consultation documents | Timetable | About the consultation | Background | Proposed additional RASML statements - Background | Proposed editorial changes | Proposed changes (with change-tracking) | Content of submissions | Enquiries | What will happen | Privacy information | More information The TGA sought comments from interested parties on the wording of additional advisory statements for first-generation sedating antihistamines for oral use, for inclusion in the Required Advisory Statements for Medicine Labels (RASML) document.
The additional RASML advisory statements were proposed in order to ensure that health professionals, parents and carers were adequately cautioned against the use of first-generation sedating antihistamines in children, and particularly in children aged under 2 years of age.
The TGA also proposed to take this opportunity to make some editorial changes in order to harmonise the entries for each of these medicines as far as possible, to reduce the total number of entries needed to cover all eventualities, and to more clearly specify which substances are affected by these entries.
The proposed amended RASML class entries, showing the new RASML requirements in red text, are set out in Table 1, below (editorial changes are not tracked in this Table - for a full ‘tracked-changes’ version see Table 2 at the end of this document): The associated individual substance entries will also be updated accordingly. Interested parties should respond by close of business Thursday, 21 June 2018.
For historical reasons, paediatric-only antihistamine substances other than cetirizine and levocetirizine are not currently subject to a RASML requirement for a sedation warning.However, the enhanced access and availability of OTC medicines means that consumers may not always receive comprehensive advice from a practitioner or pharmacist.In the context of self-medication, the medicine label is the primary source of information for the consumer; so the label must contain the directions and advisory statements that are needed for safe and effective use of these medicines.While the death was not attributed to ingestion of promethazine, the incident raised the issue of the risk of respiratory depression when promethazine is given to infants.In regards to product labels the MSU article concluded that: 'In response to this safety concern, the TGA will be seeking to make the statement 'Do not give to children under two years of age' (which is currently a recommended statement in the applicable OTC guidelines) a mandatory warning statement on the labels of OTC liquid oral formulations of first-generation oral sedating antihistamines'.
Feedback will be released following consideration of submissions. The recent TGA Medicines Safety Update of 20 March 2018 has identified a need for additional mandatory advisory statements for labels of OTC medicines containing first-generation oral sedating antihistamines, for inclusion in the RASML.