The TGA has carried out a safety review into codeine use in children and rapid metabolisers. The review concerned the safety of use of all codeine-containing products in children and breast-feeding mothers, in the context of genetically determined rapid metabolism of codeine to morphine.
Children who metabolise codeine to morphine rapidly are at a higher risk of accidental morphine overdose, which can lead to respiratory compromise and death. Children are more susceptible to respiratory problems than adults due to their immature airway anatomy. Children who have had a tonsillectomy/adenoidectomy (referred to as adenotonsillectomy throughout this review) for obstructive sleep apnoea may be particularly susceptible to opioid-induced respiratory depression in the post-operative period. Codeine that has been metabolised to morphine can also be ingested by infants through breast milk, causing risk of respiratory depression to infants of ultra-rapid metaboliser mothers who take codeine.
Internationally, deaths have been reported in children with ultra-rapid metabolism who were given codeine for analgesia post adenotonsillectomy, and for other indications. Deaths have also been reported in the breast-fed infants of mothers who are ultra-rapid metabolisers of codeine.
Currently there are inconsistencies in the way the risks associated with ultra-rapid codeine metabolism are addressed across over-the-counter (OTC) and prescription-only codeine products in Australia. This is in contrast to other major jurisdictions including the United States, European Union and Canada. Codeine is a commonly used medication that may be perceived by the Australian public to be very safe, especially in light of its availability in OTC preparations. Therefore the warnings with regard to the potential risks associated with ultra-rapid metabolism of codeine, particularly in children, should be standardised across all codeine products, regardless of schedule.
Evidence from this safety review shows that codeine should not be used in children under the age of 12 for any reason, or in children younger than 18 years of age who have undergone adenotonsillectomy for obstructive sleep apnoea. Additionally, existing warnings contraindicating codeine use by breastfeeding mothers should be made consistent across all codeine-containing products.
After reviewing Australian and international data, the TGA recommends the following:
1. Use of codeine in children younger than 12 years of age for any indication should be contraindicated.
2. Use of codeine in children aged 12-18 years should be contraindicated post adenotonsillectomy for obstructive sleep apnoea.
3. Existing warnings contraindicating codeine use by breastfeeding mothers should be made consistent across all codeine-containing products, and warnings should be added to advise against using codeine if known to be an ultra-rapid metaboliser.
4. Health professionals, patients and caregivers should be educated regarding the variability of codeine efficacy, the possibility of ultra-rapid metabolism-related morphine overdose and the signs of such, including respiratory depression.
Please refer to the following website in TGA for details:
http://www.tga.gov.au/alert/safety-review-codeine-use-children-and-ultra-rapid-metabolisers
In Hong Kong, there are 338 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 has been posted on the Drug Office website since 2012, with the last update posted on 2 July 2015. Letters to inform local healthcare professionals of the warning were issued on 16 August 2012 and 7 June 2013. So far, the Department of Health (DH) has received one case of adverse drug reaction on a codeine-containing cough and cold medicine, and it was not related to respiratory side effects. On 5 July 2013, the Registration Committee of the Pharmacy and Poisons Board decided that the sales pack label and/or package insert of pharmaceutical products containing codeine should be updated to include the relevant safety information which are consistent with TGA's recommendation in this safety review. As previously reported on 2 July 2015, the US FDA has started evaluating the potential risk of serious side effects of codeine. DH will remain vigilant on the US FDA review's result and any safety updates of the drug by other overseas drug regulatory authorities for consideration of any action deemed necessary.
Ends/ Friday, October 02, 2015
Issued at HKT 14:00
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