Other safety alerts
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| The United Kingdom: Drug safety update: Codeine for cough and cold: restricted use in children |
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Codeine is an opioid medicine that is authorised for pain relief and to treat the symptoms of cough and cold. Codeine is converted into morphine by an enzyme called CYP2D6. Some people (known as ultra-rapid metabolisers) convert codeine into morphine faster than others. This results in high morphine levels in the blood, which can cause toxic effects such as breathing difficulties. In 2010 the UK Commission on Human Medicines advised that over-the-counter liquid medicines that contain codeine should not be used for cough suppression in people under 18.
A European review has been conducted of the benefits and risks of using codeine to treat cough and cold symptoms in children. This followed the 2013 review of codeine for pain relief in children, which was in response to some fatal and life-threatening cases of morphine intoxication.
The review concluded that there is limited evidence that codeine is effective for treating cough and cold symptoms in children. Although impact of age on codeine metabolism is not fully understood, the current evidence suggests children under 12 are at a higher risk of serious side effects than children over 12. In addition, codeine can worsen symptoms in adolescents who already have problems with breathing. The MHRA has received 26 Yellow Card reports of respiratory side-effects associated with the use of codeine in children up to 5 August 2014.
When prescribing or dispensing codeine-containing medicines for cough and cold, consider that:
• codeine is contraindicated in
- children younger than 12 years old
- patients of any age known to be CYP2D6 ultra-rapid metabolisers
- breastfeeding mothers
• codeine is not recommended for adolescents (12 to 18) who have problems with breathing
Please refer to the following website in MHRA for details:
http://www.gov.uk/drug-safety-update/codeine-for-cough-and-cold-restricted-use-in-children
In Hong Kong, there are 348 registered pharmaceutical products containing codeine, which is an ingredient used to relieve pain and cough. Related news regarding the use of codeine in children has been released by various overseas drug regulatory authorities, and was posted on the Drug Office website since 2012 which the recent one was on 25 April 2015. Letters to healthcare professionals to draw their attention to the warning were issued on 16 August 2012 and 7 June 2013. So far, the DH has not received any adverse drug reaction report related to respiratory side-effects of codeine. On 5 July 2013, the Registration Committee of the Pharmacy and Poisons Board decided that codeine is not recommended for use in children less than 12 years of age, and the sales pack label and/or package insert of pharmaceutical products containing codeine should be updated to include the appropriate safety information. The DH will remain vigilant on any safety updates of the drug.
Ends/ Thursday, April 30, 2015
Issued at HKT 14:00
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