Codeine plus ibuprofen: a combination that can “cause severe kidney and gastrointestinal damage”. This was stated by the Safety Committee of Ema (Prac) during the meeting of the Pharmacovigilance Risk Assessment Committee on September 26-29. In particular, the Prac recommended a modification of the product information for medicines that combine codeine and ibuprofen. The purpose is to include a warning of serious harm, including death, particularly if taken for prolonged periods at higher than recommended doses.
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Hazardous combination of medicines
Specifically, it is a combination of an opioid (codeine) and an anti-inflammatory (ibuprofen), used to treat pain. And repeated use of these two medicines can lead to addiction (addiction) and abuse due to the codeine component. In this regard, the committee examined several cases of renal, gastrointestinal and metabolic toxicity, which came as a result of reports from different countries, in association with cases of abuse and dependence on codeine with combinations of ibuprofen, some of which were fatal.
Possible kidney damage
Going into the merits of the damage that could ensue, the Prac found that, “if taken at doses higher than those recommended or for a prolonged period of time, codeine with ibuprofen can cause damage to the kidneys, preventing the correct removal of acids from the blood in the urine (renal tubular acidosis) “. But the problems would not stop there, because kidney failure “can also cause very low levels of potassium in the blood (hypokalemia), which in turn can cause symptoms such as muscle weakness and lightheadedness.” Consequently, renal tubular acidosis and hypokalaemia will be added to the product information as new side effects.
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The key messages for national authorities
Given that medicines containing a combination of codeine and ibuprofen are authorized nationally, the EMA Safety Committee has agreed on key messages that the competent authorities can use when drafting their communication to healthcare professionals, with the aim of inform patients of signs of abuse and addiction and risks of serious harm. Therefore, patients should be advised to consult their doctor if they wish to use this combination of medicines for a longer period than recommended and / or at doses higher than those foreseen.
Medicines available without a prescription
But another problem arose. The Committee found that “there are medicines with codeine and ibuprofen available without a prescription in the EU”. Therefore, “since most cases of abuse and dependence have been reported in countries where these medicines are available without a prescription”, he decided “that prescription status would be the most risk-minimizing measure. effective to mitigate the harms associated with the abuse and addiction of these products “.
Recommendations, those adopted by the PRAC, which together with the key messages for communication, will be sent to the competent national authorities, so that they can decide whether to add others in their territories.