Serious Skin Reactions Reported With Ibuprofen Use In Europe

04 Oct 2019

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.

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.

“Acute generalised exanthematous pustulosis (AGEP) has been reported with use of ibuprofen-containing products,” revealed the European Medicines Agency’s Pharmacovigilance Risk...