Warning of Acute Liver Failure Added to Zolgensma Label

Warning of Acute Liver Failure Added to Zolgensma Label

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Warning of Acute Liver Failure Added to Zolgensma Label

The U.S. Food and Drug Administration (FDA) has added acute liver failure to the list of safety concerns with use of Zolgensma (onasemnogene abeparvovec-xioi) in children with spinal muscular atrophy (SMA). The therapy’s label has been updated to contain a boxed warning highlighting the risk of higher-than-normal levels of liver enzymes called aminotransferases (suggestive of liver injury), acute liver damage, and acute liver failure. SMA is caused by mutations in the SMN1 gene that impair…

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