Reactions: EMA recommends that codeine-ibuprofen combination medicines warn of possible serious harm
Reactions: EMA recommends that codeine-ibuprofen combination medicines warn of possible serious harm
The European Medicines Agency (EMA) safety committee (PRAC) has recommended a change to the information on codeine-ibuprofen combination medicines to include "a warning about serious harm, including death, especially when taken for prolonged periods at higher than recommended doses". The PRAC reviewed several cases of renal, gastrointestinal and metabolic toxicity that had been reported in association with cases of abuse and dependence on these drugs.
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