01/09/2017: EMA Communication: PRAC recommends modified-release paracetamol be removed from market

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.

The review of modified-release paracetamol has been carried out by EMA’s Pharmacovigilance Risk Assessment Committee (PRAC), following a request from the Swedish medicines authority, the Medical Products Agency, which had noted problems in managing overdose with such a product since marketing approval. The PRAC evaluated published studies and reports of overdose with these medicines, consulted experts in the management of poisoning and assessed how overdose with paracetamol is managed in the EU and other parts of the world.

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.

As the medicines involved are all authorised by national procedures, the PRAC recommendations will now be sent to the CMDh which will adopt a position.

The press release is available by clicking here.

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