The Tecfidera label now reflects a possible side effect of liver injury.
Tecfidera, Biogen Inc’s multiple sclerosis (MS) drug, has received label updates to disclose a potential liver injury that could require hospitalization.
The world’s best selling oral MS drug experienced sales of $1.03 billion in the third quarter and accounts for about a third of the pharmaceutical company’s revenue.
Biogen reports that only 14 instances of liver injury have occurred around the 230,000 patients who have taken Tecfidera.
This isn’t the first time Tecfidera has had the spotlight. Just last week, Biogen Inc. announced a settlement of a patient infringement lawsuit for $1.25 billion concerning the multiple sclerosis drug.
The label updates mention that abnormalities are resolved after use of Tecfidera ends. A few cases required that the user be hospitalized. None of the cases have led to serious conditions including liver failure, liver transplant, or death.