New Zealand – New Zealand Seeks Feedback on Safety-Focused Changes to Paracetamol Labels

The New Zealand Medicines and Medical Devices Safety Authority (Medsafe) is seeking feedback on planned changes to the warning and advisory statements for paracetamol. Medsafe floated the new labeling requirements in response to cases of acute liver failure linked to suspected overdoses.

New Zealand last changed its rules on the labeling of paracetamol products in 2013. Any company that applied to sell a new product or sought a new label for an existing product after December 2013 has to include pediatric dosing information that is “consistent” with a table provided by Medsafe. The table features maximum doses for narrow ranges of body weights and ages, such as 1 to 2 years.

A simpler set of requirements applies to products that came to market before December 2013. Key differences include the use of broader age ranges, such as 1 to 5 years old, and the lack of details on how dosing is tied to the weight of the child…