Serious Skin Reactions Reported With Ibuprofen Use In Europe
Executive Summary
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.
You may also be interested in...
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.
Dutch Firms Not Updating Product Info Fast Enough Following Safety Alerts
OTC marketing authorization holders in the Netherlands must respond more quickly to safety alerts issued at EU level which require product information updates, says regulator MEB.
Australia Rejects Hair-Loss Switch, Up-Schedules Modified-Release Paracetamol
Australia has rejected an application to switch an oral hair-loss treatment, while also up-scheduling modified release paracetamol over safety concerns.