Switzerland Monitors Safety Concerns Over Tavneos Drug After Japan Warning

Swissmedic is closely monitoring international safety concerns surrounding the drug Tavneos after Japanese authorities reported multiple deaths linked to its use.

Japanese pharmaceutical company Kissei Pharmaceutical has advised doctors not to prescribe Tavneos to new patients following reports that 20 people died after taking the medication since its launch in 2021. The company also warned healthcare professionals about the risk of severe liver dysfunction.

Tavneos, developed by Amgen, is used to treat rare autoimmune diseases. Japanese officials urged doctors to carefully review ongoing treatments and determine whether patients should continue using the drug.

International regulators have also increased scrutiny over the medication. The Food and Drug Administration is reportedly considering withdrawing approval for the drug in the United States, while the European Medicines Agency has launched a formal safety review.

Swissmedic confirmed that it continuously monitors global developments involving medicines approved in Switzerland and remains in contact with international regulatory agencies. Tavneos, also known as Avacopan, has been approved for use in Switzerland since 2022.

The Swiss regulator stated that it actively analyzes safety data as part of its ongoing market surveillance process. However, Swiss authorities clarified that no formal procedure currently exists to suspend or withdraw Tavneos from the Swiss market.

As a result, the drug remains authorized for use in Switzerland while investigations continue internationally.