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Monday, 13 April 2026
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8 deaths overseas but no TGA alert

Posted 13 April 2026 AM

The FDA has issued a warning of fatalities associated with a rare disease drug which is also listed on the PBS, but the TGA is withholding similar action as no such adverse events have occurred in Australia.

"FDA is alerting patients and health care professionals about serious postmarketing cases, including fatal cases, of drug-induced liver injury (DILI) associated with Tavneos," the FDA said at the end of March. "Some cases involved vanishing bile duct syndrome (VBDS), which is characterised by progressive destruction and disappearance of the bile ducts in the liver."

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