Safety Information

Use of Cough and Cold Medicines in Children

Please note the information contained in this link has been superseded (the recommendations remain the same). The following link contains the most up-to-date information: www.medsafe.govt.nz/hot/alerts/CoughandCold/InfoOct2009.asp

August 2009

What is the common cold?

The common cold is a minor infection of the upper respiratory tract (nose and throat) that can be caused by several different viruses. It is a self-limiting condition which means it runs a definite course and resolves without treatment. The common cold is not the same as influenza (flu). Viruses that cause the common cold are different and tend to be less severe compared to those that cause the flu. Cold symptoms usually appear one to three days after the virus enters the body and resolve spontaneously after seven to ten days.

The common cold is the most common infectious disease in the community. It is highly contagious and is spread primarily by coughing and sneezing. Most adults will have the common cold up to four times a year, while children are estimated to have the common cold up to eight times a year. Symptoms of the common cold include a runny nose, sore throat, coughing and sneezing.

Over the counter medicines for cough and cold

There is no cure for the common cold - symptoms of the common cold get better without treatment. Cough and cold medicines are designed to help reduce the symptoms of the common cold. The most commonly treated symptom of the common cold is the cough, hence the term cough and cold medicines.

The pharmacologically active ingredients in cough and cold medicines can be separated into four groups:

Group	Function	Examples
Mucolytics / expectorants	Loosen the mucus (phlegm) from the respiratory tract (nose, throat and lungs) thereby making it easier to expel.	Bromhexine Guaifenesin Ipecacuanha
Antitussives	Decrease the urge to cough.	Dextromethorphan Pholcodine
Nasal decongestants	Reduce the amount of fluid going to the nose (runny nose) and swelling of the inside of the nose (blocked nose).	Oxymetazoline Phenylephrine Pseudoephedrine Xylometazoline
Antihistamines	Reduce symptoms of allergy. The effects on the symptoms of the common cold are unclear.	Brompheniramine Chlorphenamine Diphenhydramine Doxylamine Promethazine Triprolidine

Many cough and cold medicines contain a combination of two or more pharmacologically active ingredients from different groups.

A list of cough and cold medicines containing one or more of the substances listed in the table above currently marketed (as of 1 March 2009) in New Zealand is available at the following link:

www.medsafe.govt.nz/hot/alerts/CoughAndCold.asp

Recent concerns about the safety and efficacy of cough and cold medicines

In January 2006, the American College of Chest Physicians questioned the use of cough and cold medicines in children.
In March 2007, a Citizen's Petition was submitted to the United States medicines regulator (the FDA) expressing concern regarding the safety and efficacy of over-the-counter cough and cold medicines in children under six years of age.
In August 2007 the FDA noted published reports of serious adverse events including death, in children receiving cough and cold medicines and public concern regarding the safety and efficacy of cough and cold medicines used in children. The FDA advised that an expert committee would be discussing the safety and efficacy of cough and cold medicines used in children.

What has happened in New Zealand?

The Medicines Adverse Reactions Committee (MARC) reviewed the safety and efficacy of cough and cold medicines for use in children in December 2007. The minutes of this meeting can be accessed at the following link:

www.medsafe.govt.nz/profs/adverse/Minutes132.htm

Based on the available evidence presented to them, the MARC considered that the risk-benefit profile for the use of cough and cold medicines in children under two years of age is unfavourable. The review concluded that there is:

Very limited evidence for efficacy of these medicines in children under two years of age.
An absence of evidence-based dosage advice for the use of cough and cold medicines in children aged less than two years.
Evidence of harm in therapeutic use in this age group.
Evidence of significant toxicity, including death, in overdose in this age group.

As a result Medsafe worked together with New Zealand sponsors to amend the product packaging for cough and cold medicines to include the statement " Must not be used in children under two years of age ", or words to this effect, in time for the 2009 cough and cold season.

Have cough and cold medicines been restricted in children in other countries?

United States

Yes. In January 2008 the FDA advised that cough and cold medicines should not be used to treat infants and children under two years of age because serious and potentially life-threatening side effects can occur from such use. The pharmaceutical companies in the United States have volunteered to restrict the use of cough and cold medicines in children under four years of age. For further information please see the FDA website:

www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/2008/ucm116964.htm

Canada

Yes. In December 2008 the Canadian medicines regulator (Health Canada) advised that cough and cold medicines should not be used (contraindicated) to treat infants and children under six years of age. For further information please see the Health Canada website:

www.hc-sc.gc.ca/ahc-asc/media/advisories-avis/_2008/2008_184-eng.php

United Kingdom

Yes. In February 2009 the UK medicines regulator (the MHRA) advised that cough and cold medicines should not be used in infants and children under six years of age, and restricted the sale of these medicines to pharmacies for children aged between 6 and 12 years old. For further information please see the MHRA website:

www.mhra.gov.uk/NewsCentre/Pressreleases/CON038902

Australia

Yes. In April 2008 the Australian medicines regulator (the TGA) advised that cough and cold medicines should not be used in infants and children under two years of age. For further information please see the TGA website:

www.tga.gov.au/media/2008/080409cold.htm

The New Zealand Cough and Cold Review Group

Medsafe has continued to review the safety and efficacy of cough and cold medicines in children. Since there is less evidence of harm and limited evidence of efficacy of these medicines in children over two years of age, further expert advice was sought. Medsafe has formed the Cough and Cold Review Group to assess the risk-benefit profile of these medicines in children up to twelve years of age and to advise on the implementation and communication of their recommendations.

The Group includes representatives from the New Zealand Centre for Adverse Reactions Monitoring, the New Zealand College of Pharmacists, the College of GPs, the Paediatric Society, the Pharmaceutical Society, the pharmaceutical industry, the Medicines Adverse Reactions Committee, Plunket and the public.

Two meetings of the Group were scheduled for 23 July 2009 and 18 August 2009. At the first meeting the Group considered the efficacy and safety of cough and cold medicines in an assessment of the risk-benefit profile of these medicines and possible risk management options. At the second meeting the Group considered implementation, communication and education strategies for the risk management options.

The minutes of the first meeting and the slides presented at the first meeting can be found at the following links:

Minutes of the first meeting of the Cough and Cold Review Group
Presentation on pharmacokinetics ( Adobe PDF document 70 KB)
Presentation on efficacy ( Adobe PDF document 182 KB)
Presentation on safety ( Adobe PDF document 243 KB)
Presentation on risk-benefit balance ( Adobe PDF document 22 KB)

The minutes of the second meeting and the slides presented at the second meeting can be found at the following links:

Minutes of the second meeting of the Cough and Cold Review Group
Presentation on efficacy of bromhexine and topical nasal decongestants ( Adobe PDF document 223 KB)
Presentation on safety of bromhexine and topical nasal decongestants ( Adobe PDF document 165 KB)