EMA/PRAC recommends market removal of modified-release paracetamol

1 September 2017

At its late August meeting, the European Medicines Agency’s (EMA) Pharmacovigilance Risk Assessment Committee (PRAC) has recommended that modified- or prolonged-release paracetamol pro Saveducts (designed to release paracetamol slowly over a longer period than the usual immediate-release products) should be removed from the market.

The decision was taken in view of the difficulties of managing overdose in patients, due to the complex way these medicines release paracetamol into the body.

After evaluating published studies and consulting experts, the Committee confirmed that when used in the approved way, modified-release paracetamol tablets have acceptable benefits and risks. However, experience has shown that in overdose, because of the way the paracetamol in modified-release products is released in the body, the usual treatment procedures developed for immediate-release products are not appropriate. The PRAC therefore recommended the suspension of the marketing authorisations of these medicines.

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