Revised: 28 May 2013
Safety Information
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 )
