EU Suspends Modified-Release Products with Paracetamol

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EMA recommends suspending the marketing of modified- or prolonged-released products containing paracetamol due to a difficulty in managing overdose.

The Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA) announced on Dec. 15, 2017 that it was recommending the suspension of modified- or prolonged-released products containing paracetamol. The recommendation was made after it was determined that the risk of overdose outweighed the benefits of longer-acting product.

Europe’s Co-ordination Group for Mutual Recognition and Decentralised Procedures–Human (CMDh) agreed with the advice, stating there was no proved way to adapt the management of overdose across the European Union to cover both immediate- and modified-release paracetamol drugs. “The CMDh therefore endorsed the PRAC recommendation that the marketing authorizations for medicines containing modified-release paracetamol, alone or combined with the opioid medicine tramadol, should be suspended,” EMA stated in a press release.

EMA plans to suspend marketing authorization of such products until companies can provide the agency with practical EU-wide measures to prevent overdose of the drugs. Immediate-release paracetamol products are not affected by the review and will continue to be available.


Source: EMA