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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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.
French medicines regulator ANSM warns that use of certain OTC NSAIDs increases the risk of serious complications when suffering from a minor infection. The agency is advising consumers not to use iburofen or ketoprofen to treat pain or fever, and to instead opt for paracetamol.