Revised: 8 June 2010
Publications
Sale restrictions on some cough and cold medicines for children under 12
Cough and cold medicines for children under 12 years old will now be sold only in pharmacies except for those containing ingredients such as honey, lemon and other natural substances.
Medsafe Group Manager Dr Stewart Jessamine said the move means cough and cold medicines containing dextromethorphan, phenylephrine and ipecacuanha will remain available in supermarkets provided they are re-labelled for use in adults and children over 12 years old.
However, oral cough and cold medicines that contain ingredients such as glycerol, guaiphenesin, honey, lemon and other natural substances will remain available in supermarkets for use in children over six years of age. These ingredients are used to relieve chesty coughs and are currently found in the the Vicks and Lemsip range of products available in supermarkets.
The Medicines Classification Committee and Medsafe had recommended to the Health Minister that the sale of some oral cough and cold medicines for children under 12 years old be restricted only in pharmacies due to concerns about their safety and efficacy.
"By reclassifying products containing dextromethorphan, phenylephrine and ipecacuanha as pharmacy-only medicines, parents will now be able to get professional advice on how to use these medicines safely when they buy these products for their children," Dr Jessamine explained.
The safety concerns have triggered similar changes being made or considered by overseas regulators, particularly the United Kingdom’s Medicines and Healthcare Products Regulatory Agency and Australia’s Therapeutic Goods Administration.
Medsafe will be working with pharmaceutical manufacturers to implement the classification and labelling changes, and re-labelled stocks are expected to become available after winter.
"In the meantime, I would like to advise parents not to use over-the-counter cough and cold medicines for children under six years of age," Dr Jessamine said.
"If a parent is unsure of the best way to treat their child, they should seek advice from their general practitioner or a healthcare professional."
ENDS
Background:
- The Medicines Classification Committee is a statutory committee that makes recommendations to the Minister of Health in respect of the classification of medicines as prescription medicines, restricted medicines or pharmacy-only medicines.
- The Medicines and Medical Devices Safety Authority (Medsafe), a business unit of the Ministry of Health, is responsible for the regulation of therapeutic products in New Zealand.
- Information on the recommendations made by the Cough and Cold Review Group, including questions and answers on over-the-counter cough and cold medicines, is available on Medsafe's website: www.medsafe.govt.nz/hot/alerts/CoughandCold/InfoOct2009.asp
- The minutes of the Medicines Classification Committee's 13 April 2010 meeting, during which the proposed reclassification of some cough and cold medicines for children under 12 was considered, are available on Medsafe's website: www.medsafe.govt.nz/profs/class/mccMin13April2010.htm
For queries, please contact: Luz Baguioro, Media Advisor (04 496 2349, 021 802 622)
