PRAC to Review Risks of Modified-Release Paracetamol

The the European Medicines Agency's (EMA's) Pharmacovigilance Risk Assessment Committee (PRAC) will review the risks and benefits of modified- and prolonged-release paracetamol (acetaminophen) tablets, the agency said today.

Unlike immediate-release paracetamol tablets, modified- or prolonged-release paracetamol tablets are designed to release the drug over a prolonged period.

"The standard procedures for assessing and managing overdose and poisoning with paracetamol are designed for the immediate-release products," the agency explained in a news release. "In recent years, there have been a number of cases of overdose with certain modified-release paracetamol tablets which indicate that the standard procedures may not be entirely suited to treat overdoses with the latter products," they said.

Modified-release medicines combining paracetamol with other painkillers will also be covered in their review, the EMA said.

The PRAC review was requested by the Swedish medicines regulator, the Medical Products Agency.

"The PRAC will evaluate available evidence to determine the risk of overdose with modified- and prolonged-release paracetamol, and whether any additional measures need to be taken. In the meantime, patients who have any concerns about their medication should discuss them with their healthcare professional," the EMA said.

Immediate-release paracetamol products have been authorized for use in all European Union (EU) member states. Products intended to have a longer action and that contain paracetamol for modified release are available in several EU member states. Such products include Alvedon 665 mg as well as others. Modified- and prolonged-release paracetamol products are also available in some member states.

The PRAC recommendations will be sent to the Co-ordination Group for Mutual Recognition and Decentralised Procedures–Human (CMDh), which will adopt a position. The CMDh is a regulatory body that represents EU member states as well as Iceland, Liechtenstein, and Norway. It is responsible for ensuring harmonized safety standards for medicines authorized via national procedures across the EU.


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PRAC to Review Risks of Modified-Release Paracetamol. Medscape. Jul 08, 2016.

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