Deaths linked to schizophrenia drug prompt TGA review
Janssen has advised Japanese medical workers to use Invega Sustenna with great care, even though it is not known whether the drug caused the deaths.
Causes of death included myocardial infarction, pulmonary embolism and suffocation due to inhalation of vomit, and in many cases death occurred about 40 days after injections of the drug.
Paliperidone palmitate was added to the Australian Register of Therapeutic Goods (ARTG) in 2010, and 13,000 patients in Australia and New Zealand have been treated with the medication. It is PBS listed.
In Australia, 240 adverse events associated with the drug have been recorded in the TGA's Database of Adverse Event Notifications, including two deaths, involving suicide and respiratory arrest.
A spokesperson for the TGA said the product information contains warnings relating to patients who have experienced blood clots, cardiac issues and oesophageal dysmotility and aspiration.