Safety Information

Trans-Tasman Early Warning System - Alert Communication

Changes to the use of bromhexine or codeine-containing cough and cold medicines in children

29 April 2015

Information for consumers and caregivers
Information for healthcare professionals
Review Summary
What actions are Medsafe taking?
How to report adverse events
Further information

Bromhexine is a mucolytic, a medicine used to break up excessive or thick phlegm associated with a chesty cough. There is concern over the number of allergic reactions, including anaphylaxis, with the use of ambroxol (to which bromhexine is metabolised).

Codeine is a pain reliever occasionally used for the relief of pain and discomfort associated with cold and flu symptoms. Codeine is changed (metabolised) to morphine in the body. There is concern regarding morphine-induced respiratory depression due to differences in codeine metabolism, particularly in young patients. This risk has been highlighted previously in Prescriber Update[www.medsafe.govt.nz/profs/PUArticles/Mar2013Codeine.htm].

Due to these concerns, Medsafe and the Medicines Adverse Reactions Committee (MARC) reviewed the use of bromhexine and codeine-containing cough and cold medicines. The MARC concluded that there was not enough evidence to support the use of these medicines in younger age groups.

The MARC recommended that the use of these medicines for cough and cold be restricted to:

  •  adults and children six years of age and over for medicines containing bromhexine
  •  adults and children 12 years of age and over for medicines containing codeine.

Medicines Adverse Reactions Committee minutes of the 160th meeting [www.medsafe.govt.nz/profs/adverse/Minutes160.htm]


Information for consumers and caregivers

  • Bromhexine-containing medicines used for cough and cold symptoms should only be used in adults and children six years of age and over.
  • Codeine-containing products used for cough and cold symptoms should only be used in adults and children 12 years of age and over.
  • Use the lowest dose that works for you and stop as soon as you can.
  • Medsafe cannot give advice about an individual’s medical condition. If you have any concerns about a medicine you are taking Medsafe encourages you to talk to your healthcare professional.
  • The medicine package will be updated with the new age restriction over the next few months. During this time, there may be differences in the information you receive from your pharmacist/doctor and the information on the medicine package. You should follow the advice that your pharmacist or doctor gives you.
  • Report any adverse reactions to the Centre for Adverse Reactions Monitoring (CARM)
  • Children with cough and colds should be allowed to rest, be made comfortable and be given plenty of fluids. Honey drinks can help to soothe a cough in children over one year of age. This was a recommendation from the Cough and Cold Review Group.

 

Information for healthcare professionals

  • Bromhexine-containing medicines used for cough and cold symptoms are restricted to adults and children six years of age and over.
  • Codeine-containing products used for cough and cold symptoms are restricted to adults and children 12 years of age and over.
  • Use the lowest effective dose for the shortest possible duration.
  • The package labelling for bromhexine-only containing products will be updated to include this new age restriction. In the meantime, consumers and caregivers should be advised that bromhexine-only containing products are restricted for use in adults and children six years of age and over.
  • Discuss the benefits and risk of harms of bromhexine or codeine treatment before commencing therapy.
  • The Cough and Cold Review Group recommended that children with cough and colds should be allowed to rest, be made comfortable and be given plenty of fluids. Honey drinks can help to soothe a cough in children over one year of age
  • Report any adverse reactions to the Centre for Adverse Reactions Monitoring (CARM).

Review Summary

  • Bromhexine

    There is insufficient evidence for the use of bromhexine for productive coughs associated with an upper respiratory tract infection. The majority of studies were small trials performed in the 1970s which showed the effectiveness of bromhexine in long-term conditions such as chronic bronchitis. However, it is not clear if this can be extrapolated to upper respiratory tract infections which are self-limiting.

    There have been international reports of rare, but serious, side effects associated with the use of bromhexine. These side effects include serious allergic reactions, including anaphylaxis and severe cutaneous adverse reactions.
  • Codeine

    There is limited evidence supporting the use of codeine in acute cough in both adults and children. Positive results for the use of codeine in suppressing cough are based on small trials from the 1960s and have not since been replicated in larger trials. In addition, codeine is a prodrug for morphine, which requires additional considerations due to the risk of toxicity.   

What actions are Medsafe taking?

Medsafe is working with the sponsors of these products to ensure data sheets and Consumer Medicine Information appropriately outline the safety of bromhexine and codeine.

In addition, Medsafe will be working with the sponsors of bromhexine-only products to update the package labelling to warn against the use of these medicines in children under six years of age.

How to report adverse events

Phone + 64 3 479 7247 to speak to a Medical Assessor at the Centre for Adverse Reactions Monitoring (CARM)
Online Submit a report to CARM
Prescribers can submit using the online reporting tool available in patient management software
Yellow Card A completed Yellow card can be submitted to CARM via email, fax or mail (address is on the card)
Email carmnz@otago.ac.nz
Fax +64 3 479 7150


Medsafe cannot give advice about an individual’s medical condition.  If you have any concerns about a medicine you are taking Medsafe encourages you to talk to your healthcare professional.

Further information

Cough and Cold Review [www.medsafe.govt.nz/hot/alerts/CoughandCold/InfoOct2009.asp]

European Medicines Agency decision – Bromhexine [www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2015/01/news_detail_002248.jsp&mid=WC0b01ac058004d5c1]

European Medicines Agency decision – Codeine [www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2015/03/news_detail_002287.jsp&mid=WC0b01ac058004d5c1]