EMA’s PRAC Recommends Removal of Modified-Release Paracetamol

The European Medicines Agency (EMA) has recommended removing modified- or prolonged-release paracetamol products from the market following a review by its Pharmacovigilance Risk Assessment Committee (PRAC). Experts noted that the mechanism of drug release for these products after an overdose could put patients at risk.

The Swedish medicines authority, the Medical Products Agency, requested a review on the safety of modified-release paracetamol products after noting problems in managing an overdose. Because of the way the paracetamol in modified-release products is released in the body, the usual treatment procedures for immediate-release products are not appropriate.

Doctors may not be aware that modified-release paracetamol has been taken-this affects decisions such as when and for how long an antidote should be given. The overdose could cause severe liver damage or death. With modified-release products that also contain tramadol, management is further complicated by the additional effects of tramadol overdose.

PRAC could not identify means to minimize the risk to patients, or a feasible and standardized way to adapt the management of paracetamol overdose to allow for cases involving modified-release products. The Committee has, therefore, concluded that the risk following an overdose outweighs the advantages of having a longer-acting preparation. The marketing of modified-release paracetamol medicines should be suspended, it says.

Products covered by this review contain paracetamol for modified-release and are intended to be taken by mouth and have a longer action. They are available in Belgium, Denmark, Finland, Luxembourg, Portugal, Romania, and Sweden under various names including Alvedon 665 mg, Panadol Artro, Panadol Extend, Panadol Retard 8 hours, Panodil 665 mg, Paratabs Retard and Pinex Retard. Modified- release medicines containing paracetamol with the opioid painkiller tramadol are available under the names Diliban Retard or Doreta in Bulgaria, Czech Republic, Estonia, Hungary, Iceland, Latvia, Lithuania, Poland, Portugal, Romania, Slovakia, Slovenia and Spain, and these medicines are also covered by this review.

The review of modified-release paracetamol was initiated on 30 June 2016 at the request of Sweden, under Article 31 of Directive 2001/83/EC.

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