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Safety Information

Revised: 28 May 2013

Further information on the Cough and Cold Review Group

Medsafe has previously taken regulatory action to restrict the use of cough and cold medicines to children two years of age and over, on the advice of the Medicines Adverse Reactions Committee (MARC). Background information on this restriction is available on the Medsafe website at the following link:
www.medsafe.govt.nz/profs/adverse/Minutes132.htm

Medsafe has continued to review the safety and efficacy of cough and cold medicines in children with further expert advice from the MARC. In recognition of the impact any changes would have for caregivers, healthcare professionals and the pharmaceutical industry, Medsafe formed the Cough and Cold Review Group to assess the benefits and risks of cough and cold medicines in children. The Cough and Cold Review Group was asked to recommend appropriate regulatory actions based on their assessment and to advise on the implementation and communication of their recommendations.

The Cough and Cold Review Group comprised of the following members:
Andi Shirtcliffee (Chair) Consulting Pharmacist
Erin Beatson Clinical Advisor, Plunket
Linda Bryant Clinical Advisory Pharmacist and member of the Medicines Adverse Reactions Committee
Bob Buckham Programmes Manager, New Zealand College of Pharmacists
Sharron Cole Chair, Board of Parents Centres New Zealand
Marguerite Dalton Paediatric Society of New Zealand
Euan Galloway Chief Pharmacist Advisor, Pharmaceutical Society of New Zealand
Allison Jamieson Clinical Advisor, Plunket
Helen Kingston General Practitioner and member of the Medicines Adverse Reactions Committee
David Reith Associate Professor, Department of Women's and Children's Health, Dunedin School of Medicine, University of Otago and member of the Medicines Adverse Reactions Committee
Tim Roper Executive Director, New Zealand Self-Medication Industry Asociation
Ruth Savage Senior Medical Assessor, New Zealand Centre for Adverse Reactions Monitoring
Les Toop Professor of General Practice and Head, Department of Public Health and General Practice, University of Otago


The Group met on 23 July 2009 and 18 August 2009. At the first meeting the Group considered the efficacy and safety of cough and cold medicines in children. At the second meeting the Group finalised their recommendations, considered risk management options, and advised on implementation and communication.

Further information is available on the Medsafe website at the following links:
Minutes of the first meeting of the Cough and Cold Review Group
Minutes of the second meeting of the Cough and Cold Review Group
Presentation on pharmacokinetics ( Adobe PDF document 70KB )
Presentation on efficacy ( Adobe PDF document 182 KB )
Presentation on efficacy of bromhexine and topical nasal decongestants ( Adobe PDF document 223 KB )
Presentation on safety ( Adobe PDF document 243 KB )
Presentation on safety of bromhexine and topical nasal decongestants ( Adobe PDF document 165 KB )
Presentation on risk-benefit balance ( Adobe PDF document 22 KB )

 

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