PRAC confirms that modified-release paracetamol containing medicines should be suspended from market

06/12/2017 Press 1788 Views

The EMA Pharmacovigilance Risk Assessment Committee(PRAC) has confirmed its recommendation that modified- or prolonged-release paracetamol containing medicines (designed to release paracetamol slowly over a longer period than the usual immediate-release medicines) should be suspended from marketing.

This follows a re-examination of the previous recommendation that was made in September 2017 by the Committee. The re-examination was requested by two companies marketing modified-release paracetamol or modified-release paracetamol with tramadol.

Following the re-examination and the receipt of additional advice from experts in the field of pain management and treatment of overdose, the PRAC was still of the opinion that the advantages of having a longer-acting product did not outweigh the disadvantages if an overdose of the medicine were taken, since the usual treatment procedures developed for immediate-release products are not appropriate for modified-release paracetamol.

The PRAC’s final recommendations will now be sent to Co-ordination Group for Mutual Recognition and Decentralised Procedures – Human (CMDh), which will adopt a position.

Immediate-release paracetamol products, which are not affected by this review, will continue to be available as before.

The press release is available by clicking here.

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