EMA Specifies New Warnings For Codeine/Ibuprofen Combination Drugs

A warning about the risk of severe hypokalemia and renal tubular acidosis is set to be added to the product information of fixed dose combinations of codeine and ibuprofen marketed in the EU following an investigation by the EMA's PRAC.

Vintage inscription made by old typewriter, warning
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OTC and Rx combination drugs containing codeine and ibuprofen marketed in the EU are set to carry a new warning of serious harms, including death, particularly when taken for prolonged periods at higher than recommended doses.

Following a review of cases of renal, gastrointestinal and metabolic toxicities reported in association with cases of abuse of, and...

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