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Biogen's MS Drug Gets Liver Injury Warning

January 26, 2017

Biogen Inc.’s bestselling multiple sclerosis drug, Tecfidera, got a label update to reflect that a possible side effect is liver injury.

In the recent version of the Prescribing Information leaflet, the warning section has been updated with information about a possible liver injury which may require hospitalization. The possible side effects include substantial increase in the levels of certain compounds, which can reach above permissible normal limits. The onset of the conditions can range from a few days to a few months after the start of the drug treatment.

Biogen reported that so far, only 14 instances of liver injury have come to light out of around 230,000 patients who have taken Tecfidera.

The updated label also mentions that the abnormalities got resolved when the Tecfidera treatment was discontinued by the patients, but a few cases required hospitalization. However, none of the cases led to serious conditions like liver failure, liver transplant, or death.