Prolonged use of codeine and ibrufen can cause death – EMA

The European Medicines Agency (EMA) has warned that the prolonged use of drugs that combine ibuprofen and codeine, indicated to treat pain, causes serious kidney and gastrointestinal damage, and has even warned of several deaths because of this.

“The Pharmacovigilance Risk Assessment Committee (PRAC) reviewed several cases of renal, gastrointestinal and metabolic toxicity that have been reported in association with cases of abuse and dependence of combinations of codeine with ibuprofen, some of them which have been fatal”, describes the PRAC itself in a report prepared after its last meeting.

Therefore, the PRAC has recommended a change to the product information for codeine with ibuprofen combination medicines to include a warning about serious harm, including death, especially when taken for long periods at higher than recommended doses.

Codeine with ibuprofen is a combination of two medications, an opioid (codeine) and an anti-inflammatory (ibuprofen), used to treat pain. Repeated use of codeine with ibuprofen can lead to addiction)and abuse due to the codeine component.

Patients should be advised to consult their physician if they wish to use codeine with ibuprofen for longer than recommended and/or at higher than recommended doses.

As announced by the EMA, the PRAC recommendations, together with the key messages for communication, will be sent to the competent national authorities, who may decide on the need for additional communication at the national level.

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