The experts of the European Medicines Agency (EMA) warned of the prolonged use and in higher than recommended doses of the drugs they combine codeine (opioid) and ibuprofenadding severe kidney and gastrointestinal damage, including death, as potential side effects.
As confirmed to Efe today by a source from the European regulatory authority, the Pharmacovigilance Risk Assessment Committee (PRAC) recommended, in its latest monthly meeting, an amendment to the prospectus of drugs combining codeine and ibuprofen to include a notice of “serious harm, including deathespecially when taken for prolonged periods at doses higher than those recommended.
“The committee looked into several cases of renal toxicitygastrointestinal and metabolic disturbances which have been reported in association with cases of codeine abuse and addiction to ibuprofen combinations, some of which have been fatal.
These drugs combine an opioid (codeine) and an anti-inflammatory (ibuprofen) and are used to treat pain, but the PRAC notes that repeated use can lead to addiction and abuse due to the codeine component.
Codeine is used to it relieve mild, moderate and severe pain. It is also often used in conjunction with other medications to reduce cough. Codeine helps relieve symptoms but does not treat the cause of the symptoms or accelerate recovery.
The committee concluded that when taken at higher than recommended doses or for a longer time, codeine with ibuprofen can damage the kidneys, preventing them from eliminating properly. acids from the blood in the urine.
Additionally, it can also cause kidney malfunction very low levels of potassium in the bloodwhich in itself can cause symptoms such as muscle weakness and dizziness.
These two new side effects, known as “Renal tubular acidosis” and “hypokalaemia”are now added to the prospectus of drugs using this combination, drugs that are used nationally in European Union (EU) countries.
EMA has sent these recommendations to the relevant national authorities, along with key messages for the correct communication on this side effect, and it is they who decide on the need to offer additional information at national level. EFE
Source: Clarin
