Other safety alerts
|
| |
| China: CFDA announcement on revision of package insert of medicines containing Codeine (Issue no. 199, 2016) |
| |
In Hong Kong, there are 323 registered pharmaceutical products containing codeine which are classified according to the codeine concentration in the product, e.g. products containing codeine less than 0.2% are pharmacy only medicines while products containing codeine 0.2% or more are prescription only medicines. News on the safety of codeine was previously issued by various overseas drug regulatory authorities, and was posted on the Drug Office website since 2012, with the latest update posted on 21 December 2016. Letters to inform local healthcare professionals on the risk of respiratory depression were issued on 16 August 2012, and on the safety recommendations that codeine is restricted to patients older than 12 years old were issued on 7 June 2013. So far, the Department of Health (DH) has received one adverse drug reaction case after receiving codeine, which was not related to respiratory depression.
On 5 July 2013, the Registration Committee of the Pharmacy and Poisons Board decided that the sales packs and/or package inserts of pharmaceutical products containing codeine should be updated to include the relevant safety warnings. As reported on 2 July 2015, the US FDA is also evaluating the potential risk of serious side effects of codeine, DH will continue to remain vigilant on the US FDA review findings as well as safety updates on codeine issued by other overseas drug regulatory authorities.
Please refer to the following Chinese website for details:
http://www.drugoffice.gov.hk/eps/news/../27414.html
Ends/Thursday, January 05, 2017
Issued at HKT 15:00
|
| |
|
