Following a review, the European Medicines Agency (EMA) Pharmacovigilance Risk Assessment Committee (PRAC) has recommended that modified- or prolonged-release paracetamol (acetaminophen) be removed from the market.
“This is in view of the risks to patients from the complex way these medicines release paracetamol into the body after an overdose,” the EMA said in a news release.
As previously reported by Medscape Medical News, the PRAC launched a review of modified-release paracetamol at the request of the Swedish medicines regulator, which had noted problems in managing overdose with the product.
The PRAC reviewed 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 Europe 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 immediate-release products are not appropriate,” the EMA said in the news release.
The concern is that if health providers are not aware that a patient has taken modified-release paracetamol, which affects decisions such as when and for how long to give an antidote, overdose might result in severe liver damage or death, they point out.
In modified-release products that also contain the painkiller tramadol, this could be complicated further because of the added 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 hard to decide what type of management is needed, the EMA notes.
The PRAC could not identify ways to minimize the risk to patients, or a feasible and standardized way to adapt the management of paracetamol overdose across Europe to allow for treatment of cases that involve modified-release preparations, the EMA said.
The Committee concluded that, on balance, the “risk following overdose with modified-release paracetamol 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 are not affected by this review and will continue to be available, the EMA said.
The PRAC recommendations will be sent to the Co-ordination Group for Mutual Recognition and Decentralised Procedures–Human (CMDh), which will adopt a position on the issue.
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