EMA Committee Warns Ibuprofen Can Seriously Exacerbate Infections
EMA's Pharmacovigilance Risk Assessment Committee wants ibuprofen and ketoprofen products to carry new warnings related to the risk of exacerbating serious infections.
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Rx-to-OTC switches of the painkillers dexibuprofen and single-pill combinations of ibuprofen and paracetamol as well as the cough medicine levodropropizine, all for oral use, will be considered at the next German Expert Committee for Prescription meeting on 13 July.
The latest EU OTC regulatory news: the EMA with EC and NCAs publish COVID-19 Business Continuity Plan; the CMDh decides to implement the PRAC's recommendations for ibuprofen and ketoprofen; the EMA and HMAs learn lessons from N-nitrosamine impurities in sartans; and the CHMP revisits its opinion on ranitidine following a request by a manufacturer.
The European Medicines Agency’s Pharmacovigilance Risk Assessment Committee (PRAC) advises ibuprofen manufacturers to add warnings of acute generalised exanthematous pustulosis associated with use of the drug to patient information leaflets.