Slow-release paracetamol under review: TGA

Overdose concerns have been raised about prolonged release paracetamol products, such as Panadol Osteo, leading to a review by the TGA.

Australia's medicines regulator, the TGA, is reviewing the sale of slow-release paracetamol products after concerns were raised in Europe about the potential for overdose.

The European Medicines Agency this week recommended the modified or prolonged-release paracetamol products, such as Panadol Osteo, should be removed from the market.

According to the Pharmaceutical Journal, the EMA recommendation was made in view of "difficulties" managing overdose in patients because of the complex way these analgesic is released in the body.

The TGA on Wednesday said it was aware of the review carried out by the EMA's Pharmacovigilance Risk Assessment Committee (PRAC).

"The TGA is reviewing information to determine what, if any, action is required in Australia and will take into account the PRAC recommendations," the TGA said in a statement.

The TGA said it had received 43 notifications concerning adverse events with overdose in association with the modified release paracetamol products.

"These reports were received between 2005 and 2017. None of the reports list death as an outcome."


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Source: AAP


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