EMA recommends modified-release paracetamol be removed from the market

The EMA has recommended suspending authorisation of prolonged-release paracetamol products because of concerns over managing overdosing patients. 

European Medicines Agency

Modified- or prolonged-release paracetamol products should be removed from the market, the European Medicines Agency (EMA) has recommended.

The Pharmacovigilance Risk Assessment Committee (PRAC) of the EMA made its decision “in view of the difficulties of managing overdose in patients because of the complex way these medicines release paracetamol into the body”, the organisation said.

The products are designed to release paracetamol slowly over a longer period than the usual immediate-release products.

The PRAC confirmed that when used in the approved way, modified-release paracetamol tablets have acceptable benefits and risks.

However, the committee said experience had shown that when people overdosed, the usual treatment procedures developed for immediate-release products were not appropriate because of the way the paracetamol in modified-release products was released in their bodies.

Following these findings, the committee has recommended suspending the marketing authorisations of these medicines.

Meanwhile, the PRAC also announced that 79 members of the public had applied to take part in its first ever public hearing on valproate, due to take place later this month (September 2017).

The agency invited people to talk about their experiences with valproate — a medicine that treats epilepsy, bipolar disorder and migraine.

All those who contacted the EMA will all be invited to attend the public hearing, although speaker slots will be limited. The EMA said it would contact all applicants in the next fortnight, and for those unable to attend the hearing, it would be broadcast live on the EMA’s website.

The public hearing is part of a review by the PRAC that looks at the safety of using valproate-containing medicines in women and girls who are pregnant or of childbearing age.

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Citation
The Pharmaceutical Journal, EMA recommends modified-release paracetamol be removed from the market;Online:DOI:10.1211/PJ.2017.20203509