Clozapine monitoring least stringent in Australia

The TGA reviewed monitoring guidelines in the US, UK, Canada and Australia after a fellow of the RANZCP complained that the requirements were “unnecessarily onerous”. 

Requirements in Australia remain less stringent than in each of those countries, even after the Food and Drug Administration relaxed rules for the US in 2005, the documents show.

The psychiatrist could not be reached for comment, but a RANZCP spokesperson said the college was satisfied with the TGA’s conclusion that “there is no justification for reducing or ceasing the current white cell count monitoring requirements”.

The TGA noted that the rate of moderate leukopenia was “very significant” at 11.8/1000 between weeks 19 to 52, and 6.1/1000 after one year’s use.