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PRAC recommends modified-release paracetamol be removed from market

Overdose complex and difficult to manage with modified-release products

Following a review, the European Medicines Agency’s experts in medicines safety have recommended that modified- or prolonged-release paracetamol products (designed to release paracetamol slowly over a longer period than the usual immediate-release products) should be suspended from marketing. This is in view of the risks to patients from the complex way these medicines release paracetamol into the body after an overdose.

Experience has shown that in overdose (particularly at high doses), 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. If doctors are not aware modified-release paracetamol has been taken, which affects decisions such as when and for how long to give an antidote, overdose might result in severe liver damage or death. In modified-release products that also contain the painkiller tramadol this could be complicated further because of the additional effects of overdose with tramadol.

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 what type of management is needed. The Committee could not identify means to minimise the risk to patients, or a feasible and standardised way to adapt the management of paracetamol overdose across the EU to allow for treatment of cases that involve modified-release preparations. It concluded on balance that the risk following overdose with these medicines outweighs the advantage of having a longer-acting preparation. The Committee therefore recommended that marketing of modified-release paracetamol medicines should be suspended. Immediate-release paracetamol products, which are not affected by this review, will continue to be available as before.

More information on this is included in the hyperlink below:

Paracetamol-modified release

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