European Medicines Agency announces safety review of prolonged-release paracetamol


A safety review of modified and prolonged-release paracetamol has been launched following reported cases of acute overdose, the European Medicines Agency (EMA) has announced.

A benefits and risks assessment was triggered by an investigation by the Swedish Poison Information Centre, which looked in detail at 53 cases of acute overdose involving the modified release paracetamol product Alevedon (665mg).

Alevedon is a prescription-only medicine in Sweden and is traditionally prescribed for the treatment of chronic pain that requires continuous dosing.

The investigators concluded that the current standard procedures for assessing and managing paracetamol overdoses may be unsuitable for products like Alevedon because they were originally designed for immediate-release paracetamol tablets.

The Swedish medicines regulator the Medical Products Agency raised the poison centre’s concerns with the EMA, which led to the safety review being announced on 8 July 2016.

The EMA’s Pharmacovigilance Risk Assessment Committee will review the evidence to find out the risk of overdose with modified and prolonged-release paracetamol, and whether any additional measures need to be taken. The review will exclude immediate-release paracetamol products.

Last updated
The Pharmaceutical Journal, European Medicines Agency announces safety review of prolonged-release paracetamol;Online:DOI:10.1211/PJ.2016.20201427

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