The European medicines safety agency is reviewing the safety of the PAH drug selexipag (Uptravi) following the deaths of 5 patients taking the medicine in France.
However, an advisory note published on its website the European Medicines Agency (EMA) says that based on a preliminary review of the available data Uptravi may continue to be used in both existing and new patients.
Doctors prescribing the drug are advised to “follow recommendations and precautions in the current prescribing information”.
The TGA said it was aware of the safety review and had been liasing with the Australian sponsor (Actelion) to obtain more information.
No adverse events had been recorded in the Australian Database of Adverse Events for selexipag up to 16 November last year, but the regulatory body will continue to monitor the issue, a spokesperson told the limbic.