其 他 安 全 警 示
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| European Union: Codeine with ibuprofen: PRAC adds warning for serious renal and gastrointestinal harms (English only) |
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European Medicines Agency (EMA) announces that the Pharmacovigilance Risk Assessment Committee (PRAC) has recommended a change to the product information for codeine with ibuprofen combination medicines to include a warning of serious harms, including death, particularly when taken for prolonged periods at higher than recommended doses.
Codeine with ibuprofen is a combination of two medicines, an opioid (codeine) and an anti-inflammatory (ibuprofen), which are used to treat pain. Repeated use of codeine with ibuprofen may lead to dependence and abuse due to the codeine component.
The PRAC reviewed several cases of renal, gastrointestinal and metabolic toxicities that have been reported in association with cases of abuse of and dependence from codeine with ibuprofen combinations, some of which have been fatal. The PRAC found that, when taken at higher than recommended doses or for a prolonged period of time, codeine with ibuprofen can cause damage to the kidneys, preventing them from removing acids properly from the blood into the urine (renal tubular acidosis). Kidney malfunction can also cause very low levels of potassium in the blood (hypokalaemia), which in turn may cause symptoms such as muscle weakness and light-headedness. Therefore, renal tubular acidosis and hypokalaemia will be added to the product information as new side effects.
The PRAC also noted that there are medicines containing codeine with ibuprofen which are available without medical prescription in the European Union. As most of these cases were reported in countries where these medicines are available without a prescription, the PRAC considered that prescription-only medicine status would be the most effective risk minimisation measure to mitigate the harm associated with abuse and dependence of these products.
Please refer to the following website in EMA for details:
http://www.ema.europa.eu/en/news/meeting-highlights-pharmacovigilance-risk-assessment-committee-prac-26-29-september-2022
In Hong Kong, there is no registered pharmaceutical product containing both codeine and ibuprofen.
Ends/Monday, Oct 3, 2022
Issued at HKT 16:00
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