Health Sciences Authority (HSA) would like to provide an interim update on the new contraindication and precautionary recommendations issued by the US Food and Drug Administration (FDA), European Medicines Agency (EMA) and Health Canada on the use of codeine-containing products in paediatric patients for pain relief. EMA is also separately reviewing the use of codeine-containing preparations used for cough or cold in children, and its recommendations are expected at the end of 2014. HSA is currently reviewing the use of codeine-containing preparations in children in totality, covering both pain relief as well as cough suppression for the relief of unproductive cough and will advise our healthcare professionals on the recommendations relevant to our local context in due course.
In August 2012, the US FDA reviewed the use of codeine following reports of three deaths and a case of severe respiratory depression in young children (aged 2 to 5 years old) who received codeine following tonsillectomy and/or adenoidectomy for obstructive sleep apnoea syndrome. These children had evidence of being “ultra-rapid metabolisers” of substrates of CYP2D6, which include codeine, and they may have been particularly sensitive to the respiratory depressant effects resulting from the increased conversion of codeine to morphine. Data from the US FDA’s Adverse Event Reporting System database, from 1999-2012, identified a further 10 cases of paediatric death and three cases of drug overdose associated with codeine use. Of these, three were ultra-rapid metabolisers, three were extensive metabolisers and one was a likely ultra-rapid metaboliser. Eight of the cases involved adenotonsillectomy. In August 2007, the US FDA reported the death of a healthy breast-fed 13-day-old baby, whose mother was taking a low dose of codeine for episiotomy pain. The mother was found to be an ultra-rapid metaboliser of codeine and the baby was shown to have high blood levels of morphine which was consumed through breast milk.
HSA is embarking on a review of codeine-containing preparations in Singapore for pain relief as well as the relief of cough symptoms in children, taking into account the recommendations made by international regulatory agencies. In the meantime, healthcare professionals are advised to exercise caution when codeine is administered to paediatric patients. HSA will provide an update on the outcome of our review when it is completed.
Please refer to the following website in HSA for details:
http://www.hsa.gov.sg/content/hsa/../pain_relief_paediatric_patients.html
In Hong Kong, there are 350 registered pharmaceutical products containing codeine, which is an ingredient used to relieve pain and cough. Related news regarding the use of codeine have also been released by US FDA, EMA, MHRA and Health Canada and were posted on website of Drug Office on 16 August 2012, 21 February 2013, 7 June 2013, 15 June 2013, 29 June 2013 and 12 April 2014. Letters to inform healthcare professionals on the issue were issued on 16 August 2012 and 7 June 2013. On 5 July 2013, the Registration Committee of the Pharmacy and Poisons Board (the Committee) decided that codeine is not recommended for use in children less than 12 years of age and the sales pack and/or package insert of pharmaceutical products containing codeine should be updated to include the appropriate safety information. The Department of Health will remain vigilant on any safety updates of the drug and actions taken by overseas regulatory authorities of any action deemed necessary.
Ends/ Friday, September 05, 2014
Issued at HKT 16:00
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