Clozapine gets boxed warning on ‘potentially fatal’ GI effects
Screening for constipation is recommended as one in 10 fatal clozapine reports are related to gut disorders, says the TGA
GPs seeing patients on clozapine are being warned to monitor for signs and symptoms of gastrointestinal hypomotility following concern over serious adverse events, including fatalities.
Product information for the atypical antipsychotic has been updated and a boxed warning added because of post-market adverse events and emerging reports in the medical literature, the TGA says.
The regulator has received more than 1500 reports of gastrointestinal disorder linked to clozapine, including constipation, intestinal obstruction and abdominal pain.
“Of the 1023 clozapine reports with a fatal outcome, 103 were due to gastrointestinal disorders,” the TGA wrote in the latest Medicines Safety Update.
