Ondansetron withdrawn nationwide following safety concerns

18-Dec-2025

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Investigations are underway into incidents suspected to involve the deaths of two women and allergic reactions among patients at Kandy Hospital linked to the use of a drug intended to prevent vomiting. In this context, Cabinet Spokesperson Minister Nalinda Jayatissa stated that the drug known as Ondansetron has been completely withdrawn from use.

Speaking at the Cabinet decisions media briefing held on Dec 16, he further stated that two deaths are suspected to have occurred due to the use of Ondansetron. These suspected deaths were recorded at the National Hospital for Infectious Diseases.

The two deceased women were aged 37 and 33. In addition, an allergic reaction was reported at Kandy Hospital on the 12th after the drug was administered. Following this, the drug was fully withdrawn from use.

There are 11 registered distributors supplying this drug in the country. A maximum of 15 distributors can be registered with the National Medicines Regulatory Authority. Among the 11 registered distributors, some supply medicines manufactured in Bangladesh, while others supply medicines manufactured in India.

All these companies distribute the medicine in accordance with United States Pharmacopeia (USP) certification, not Indian certification. Investigations into the drug are currently underway, and further information will be announced after the test reports are received.