India: European Medicine Agency Recommends Modifiedrelease Paracetamol To Be Removed From The Market

On September 1, 2017, The European Medicines Agency's (EMA) Pharmacovigilance Risk Assessment Committee (PRAC) has recommended that modified or prolonged-release paracetamol products that are designed to release paracetamol slowly over a longer period should be removed from the market. The decision was taken in view of the difficulties in managing overdose in patients, due to the complex way these medicines release paracetamol into the body25.

The Committee, after evaluating published studies and consulting experts, confirmed that when used in the approved way, modified-release paracetamol tablets have acceptable benefits and risks. However, experience has shown that in event of overdose, because of the way 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 authorizations of these medicines.

The review of modified-release paracetamol was initiated on June 30, 2016, following a request from the Swedish Medicines Authority, the Medical Products Agency under Article 31 of Directive 2001/83/EC. The Swedish Medicines Authority 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 immediaterelease products are not appropriate and effective. If doctors are not aware that modified-release paracetamol has been taken, it affects decisions regarding the dosage, timing and duration of the antidote; overdose may result in severe liver damage or death. In modified-release products which also contain the painkiller tramadol, case may be further complicated 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 minimize the risk to patients, or a feasible and standardized 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.

The agency also said that it remains important that patients seek medical advice quickly if they have taken, or think they may have taken, more than the recommended amount of any paracetamol-containing product. Patients should also consult a healthcare professional if they have any other concerns about their medication.

Paracetamol is a medicine that has been widely used for many years to relieve pain and fever in adults and children.

About Pharmacovigilance Risk Assessment Committee (PRAC)26

The Pharmacovigilance Risk Assessment Committee (PRAC) is the European Medicines Agency's (EMA) committee responsible for assessing and monitoring the safety of human medicines. The PRAC was formally established in line with the pharmacovigilance legislation which came into effect in 2012 to help strengthen the safety monitoring of medicines across Europe.

Footnotes

25 http://www.ema.europa.eu/ema/index.jsp?curl=pages/ news_and_events/news/2017/09/news_detail_002806. jsp&mid=WC0b01ac058004d5c1

26 http://www.ema.europa.eu/ema/index.jsp?curl=pages/ about _us /gener a l /gener a l _content _ 0 0 0537. jsp&mid=WC0b01ac058058cb18

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