European Medicines Agency (EMA) Pharmacovigilance Risk Assessment Committee (PRAC) after conducting its review trials has given its assessment that modified release due to safety hazards related to its duration of action.
The main reason cited for this removal of paracetamol (acetaminophen) is the overdose of patients with such modified release preparations. Since the paracetamol overdose/poisoning can be deadly if the proper care is not administered in time, the modified release paracetamol interfered with the proper working and response of the antidotes like n acetylcysteine.
The max paracetamol for adults is 1000 mg as a single dose and 4 grams per day. Its mainly used for reducing pain and fever. If used in the dosing described above, its a safe drug and doesn’t cause any major side effects. This is true for the immediate release paracetamol or acetaminophen.
The additional difficulty faced in this regard was the added toxicity of tramadol as these modified release preparations are often combined with tramadol which acts as a superimposed toxicity. There was considerable difficulty in treating patients with overdose who had used these new paracetamol preparations instead of the usual immediate release ones.
The decision of how long and how much of the antidote to be given is quite simple in the immediate release paracetamol tablets. It gets very confusing particularly if its not known whether modified release or immediate release tablets have been used.
Even though a long acting drug has some convenience. the risk associated with the overdose is much more significant and hence it was decided to pull the modified version completely from the market to remove the confusion regarding the management of the acute toxicity associated with long acting drug.
The plain immediate acting paracetamol are not affected by this review and shall continue to be available in markets across Europe and can be used without these considerations.
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