Umesh Modi is a chartered accountant, and Pamini Jatheeskumar is a chartered certified accountant at Silver Levene...
  Don Lavoie is alcohol programme manager at Public Health England and Gul Root is lead...
Don Lavoie is alcohol programme manager at Public Health England and Gul Root is lead pharmacist, Health and Wellbeing Directorate, Public Health England
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a person taking pills imageDecember 19 2017

The European Medicines Agency is suspending modified-release or prolonged-release preparations containing paracetamol from the market.

It follows concerns that modified-release preparations make management of any paracetamol overdose more difficult; treatment of overdose by standard paracetamol preparations is not appropriate for modified-release medicines, and nor is it always known which type of product has been taken.

The EMA has accepted the recommendation by its Coordination Group for Mutual Recognition and Decentralised Procedures – Human (CMDh) to suspend market authorisations unless manufacturers “can provide evidence of appropriate and practical EU-wide measures to help prevent overdose with these products and adequately reduce its risk.”

Immediate-release paracetamol products are not affected by the announcement. “Because the CMDh decision was agreed by majority vote it will now be sent to the European Commission which will issue a final legally binding decision valid throughout the EU,” said the EMA.

Evidence cited for introducing the restriction includes assessment of 53 cases of acute overdose with modified-release paracetamol by the Swedish Poison Information Centre. This found that standard treatment protocols for overdose were not appropriate, because “maximum plasma concentration may occur later, and high concentrations, in particular after large doses, may persist for several days.”

EMA announcement        

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