Proposed changes to paracetamol warning and advisory statements

Overview

Medsafe is seeking comments on proposed changes to current warning and advisory statements for paracetamol.

At the December 2018 Medicines Adverse Reactions Committee (MARC) meeting, the Committee discussed a serious case report of acute liver failure in a young patient due to a suspected overdose of paracetamol. The Committee noted that they had discussed similar case reports in the past, indicating an ongoing issue (December 2018 Medicines Adverse Reactions Committee Meeting Minutes)

The Label Statements Database lists the warning and advisory statements that are required on medicine and related product labels under the Medicines Regulations 1984. Currently, the Label Statements Database has different required statements for paracetamol legacy labelling not changed since 2013. The current statements are grouped under the following conditions:

• new product applications from 1 December 2013 AND new labels for existing products from 1 December 2013
• existing products for which no changes to labels are made.

Medsafe proposes removing the current paracetamol conditions and grouping the required warning statements in dose form groups, under the following conditions:

• when sold in a liquid oral dose form
• all other dosage forms, excluding modified release
• modified release

We are seeking your views on the proposed paracetamol conditions, warning statements and dosing table. To help you with your submission, we have described the rationale for the proposed changes in the consultation document below. We will implement these new labelling requirements after this consultation through the Label Statements Database.

Medsafe is seeking your comments on:

• whether the required paracetamol warning statements should be specific to the proposed dose form groups (conditions)
• whether the proposed paracetamol dosing table is appropriate and whether a measuring device should be provided
• whether the proposed warning statements include all relevant paracetamol warning statements for each dose form group / condition
• whether any of the proposed paracetamol warning statements are unnecessary for the relevant dose form group, and if yes, why.

Medsafe proposes that the new label statements should be implemented within 18 months from the publication of the consultation outcome on the Medsafe website. 

To assist in the analysis of submissions, Medsafe will only accept submissions made through this consultation website.

What happens next

All comments will be considered. Once the analysis of submissions is complete, the Label Statements Database may be updated.

We will publish the outcome on the Outcome of Consultations web page on the Medsafe website.

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