Regulators in New Zealand have reaffirmed their intention to reclassify modified-release paracetamol as a restricted medicine. Officials proposed strengthening the restrictions on the medicine earlier this year and stuck with their decision despite respondents objecting to the reclassification ruling and how it was reached.
The New Zealand Medicines and Medical Devices Safety Authority (Medsafe) began looking into the classification of modified-release paracetamol after European regulators suspended the products this time last year. The European suspension was underpinned by concerns that, while modified-release paracetamol can be used safely, it can be impossible to know which version of the drug someone has used to overdose. As the version dictates treatment, this makes it hard to counter overdoses.
The European Medicines Agency (EMA) felt the risks posed by the overdose uncertainty outweighed the benefits, leading the European Commission to issue a legally binding decision in February. However, some national regulators have diverged from EMA. In May, Denmark opted to keep modified-release paracetamol on the market.
A parallel debate has gone on in Australia and New Zealand. In September, Australia’s Therapeutic Goods Administration proposed reclassifying modified-release paracetamol so that patients need to talk to a pharmacist before making a purchase. Medsafe held a consultation on its plans to reclassify modified-release paracetamol as a restricted, not pharmacy-only, medicine earlier in the year.
Medsafe received seven responses to its consultation. Four of the responses advocated for the drugs to remain as pharmacy-only products. Medsafe deemed one of the responses to be a valid objection, as it noted that new safety information is available. The response accused the committee of failing to properly assess all the risk-benefit issues…