December 18, Colombo (LNW): The National Medicines Regulatory Authority (NMRA) has initiated a formal inquiry into the quality and safety of the anti-nausea drug Ondansetron, following reports of complications among patients.
Dr Ananda Wijewickrama, NMRA Chairman, confirmed that samples are undergoing analysis at both the Medical Research Institute in Borella and the NMRA’s own laboratories. The pharmaceutical company responsible for importing the drug has also requested that additional testing be carried out at an accredited overseas facility.
In the meantime, the Ministry of Health has suspended the use of all injectable products produced by the Indian manufacturer linked to the affected batch. Dr Asela Gunawardena, Director General of Health Services, emphasised that investigations are ongoing and it has not yet been confirmed whether recent patient deaths are directly related to the injections.
The issue came to light after several patients at Kandy National Hospital experienced complications following administration of Ondansetron on December 12. Laboratory tests on patient blood samples revealed the presence of microorganisms, prompting an immediate halt to the use of the implicated batch.
Authorities have also launched a separate inquiry to examine a potential connection between the injections and the deaths of two patients at the National Institute of Infectious Diseases, both of whom had received the drug. Health officials stressed that patient safety remains the top priority as investigations continue.
