Serious Skin Reactions Reported With Ibuprofen Use In Europe

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.

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Marketing authorization holders (MAHs) of ibuprofen-containing products in the European Union will have to update product information to include new warnings after reports of severe skin reactions association with use of the drug.

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