Experts European Medicines Agency (EMA) warns of long-term use and excess of recommended doses of drugs that combine codeine (an opioid) and ibuprofen, and the addition of serious kidney and gastrointestinal damage, including death, as possible side effects.
As a European regulatory source confirmed to Efe today, the Pharmacovigilance Risk Assessment Committee (PRAC) recommended at its last monthly meeting that the prospectus for codeine-ibuprofen-combining products be changed to include a “serious health hazard” warning. up to death, especially with prolonged use in doses exceeding the recommended ones.
The Committee considered several cases of renal, gastrointestinal and metabolic toxicity reported in connection with cases of codeine abuse and dependence on ibuprofen combinations, some of which were fatal.
These drugs combine an opioid (codeine) and an anti-inflammatory agent (ibuprofen) and are used to relieve pain, but the PRAC notes that repeated use can lead to addiction and abuse due to the codeine component.
The committee concluded that when taken at higher doses than recommended or for longer periods of time, codeine with ibuprofen can damage the kidneys, preventing them from properly removing acids from the blood into the urine.
In addition, poor kidney function can also cause very low levels of potassium in the blood, which in itself can lead to symptoms such as muscle weakness and dizziness.
These two new side effects, known as ‘renal tubular acidosis’ and ‘hypokalemia’, have now been added to the drug prospectuses that use this combination, drugs that are used nationally in countries European Union (EUROPE).
The EMA has forwarded these recommendations to the competent national authorities, along with key messages to properly communicate this side effect, and it is they who decide whether additional information is needed at the national level. EFE
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