Posted by Michael Wonder on 17 Dec 2017
Modified-release paracetamol-containing products to be suspended from EU market
15 December 2017 - Recommendation endorsed due to the difficulty in managing overdose.
The CMDh has endorsed by majority a EMA recommendation to suspend marketing of modified- or prolonged-release products containing paracetamol (designed to release paracetamol slowly over a longer period than the usual immediate-release products). The recommendation was made by the Agency’s experts in medicines safety, the Pharmacovigilance Risk Assessment Committee.
CMDh agreed with the Agency’s advice that the advantages of a longer-acting product did not outweigh the complications of managing an overdose of the medicine, since the treatment procedures for immediate-release products are not appropriate for modified-release paracetamol. In many cases, it may not be known whether an overdose of paracetamol involves immediate-release or modified-release products, making it difficult to decide how the overdose should be managed.
