Submissions and TGA response: Metoclopramide: proposed advisory statement for medicines

The Therapeutic Goods Administration (TGA) has published the comments received in response to theConsultation: Metoclopramide: proposed advisory statements for medicines. The following two submissions were received:

Consultation submission: Australian Self Medication Industry (ASMI) (pdf,108kb)

Consultation submission: Pharmaceutical Society of Australia (PSA) (pdf,81kb)

 

1. Advisory statement: Do not use in children and adolescents aged under 18 years. The respondents supported the warning statement as proposed.

2. Advisory statement: Tell your doctor or pharmacist before use if you are taking other medicines. The respondents supported the warning statement as proposed.

3. Advisory statement: Do not use if you have epilepsy (fits). The respondents supported the warning statement, consistent with the TGA’s recent safety assessment and changes to the PI of prescription metoclopramide products. However, one of the respondents recommended that use of the term ‘seizures’ would be more appropriate than the term ‘fits’. In response to the submission, TGA considers that the statement should be amended to allow for either of these terms, given consumers’ familiarity with both. The amended statement will read ‘Do not use if you have epilepsy [fusion_builder_container hundred_percent=”yes” overflow=”visible”][fusion_builder_row][fusion_builder_column type=”1_1″ background_position=”left top” background_color=”” border_size=”” border_color=”” border_style=”solid” spacing=”yes” background_image=”” background_repeat=”no-repeat” padding=”” margin_top=”0px” margin_bottom=”0px” class=”” id=”” animation_type=”” animation_speed=”0.3″ animation_direction=”left” hide_on_mobile=”no” center_content=”no” min_height=”none”][(seizures) / (fits)]’ (using the current RASML convention of square brackets and a slash to indicate a choice of acceptable alternative wordings). The final advisory statements for metoclopramide will be included in theRequired Advisory Statements for Medicine Labels (RASML)document when it is next updated.

 

Column 1
Substance(s)
Column 2
Conditions
Column 3
Required statement(s)
Metoclopramide In preparations for oral use Do not use in children and adolescents aged under 18 years

Tell your doctor or pharmacist before use if you are taking other medicines

Do not use if you have epilepsy [(seizures) / (fits)]

TGA, 13 May 2015 ;http://www.tga.gov.au/ ;[/fusion_builder_column][/fusion_builder_row][/fusion_builder_container]