Paracetamol : Europe calls for the removal of the time release formula

nikesidoroff/epictura

Published the 06.09.2017 at 12h06

A A

Keywords :

paracétamolEMAoverdose

Paracetamol LP could disappear from the shelves of pharmacies. The Committee for Risk Assessment for Pharmacovigilance (PRAC) of the european medicines Agency (EMA) has recommended, in its last meeting, the withdrawal from the market of this specialty, one can read in a press release dated Friday.

This decision is justified by the complex mechanisms of release of paracetamol LP within the organization, which poses a risk of overdose to patients, says EMA. The health authorities of sweden are at the origin of the request for a review of this specialty.

Fatal overdoses

“The PRAC has assessed the published studies and the statements of overdoses related to this drug, consultation with experts in toxicology,” says the EMA, which advocates withdrawal from the market of all brands and forms of paracetamol extended release “.

It appears that the inappropriate use of paracetamol in LP, often associated with the formula for immediate-release may lead to a risk of fatality in overdose. And even outside of a context of misuse, the release is very uneven of the product in the body poses a problem, because the treatment is usually administered for the overdose of paracetamol immediate-release are not applicable to the formula LP.

Thus, according to the EMA, ” if the doctors do not know that a patient has taken an extended-release formulation, what dose, or when, he will not act in time to prescribe an antidote, which can cause damage to the liver severe and sometimes even death “. The risk is particularly present when the paracetamol LP is associated with tramadol.

No ways to reduce the risk

However, in many cases, it is not possible to know if the overdose is related to a formula in immediate-release or prolonged – especially as some medicines combine the two. Suddenly, the doctors may not know what type of treatment is necessary.

“The committee has not been able to identify ways to reduce the risks for the patient,” can you read. The risk-benefit ratio has been revised downwards. The PRAC recommends that all european States to withdraw these products from their market. The ball is now in the camp of the national authorities.