MS Tecfidera medication caused liver injury to 14 people

Pharmaceutical company Biogen Inc has recently received a scare from its big-selling oral multiple sclerosis drug, Tecfidera.

Tecfidera has been well-known to treat relapsing multiple sclerosis, and although, Tecfidera’s historic side effects have been linked with serious viral infections to the brain, which could lead to disability or death, more recently, the medicine has been linked to liver injuries.

Of the 230,000 patients treated with Biogen’s Tecfidera, there have been 14 reported cases of liver injury, according to a Biogen spokeswoman.

14 reported cases

Since the reported cases, Biogen has updated its labels to include a warning of potential liver injury that could result into hospitalisation. The updated label states that signs of liver injury are resolved when patients stop taking the medicine, and warnings have also been placed on their relevant website

Biogen says that the label updates have been verified and finalised with regulators earlier this year. The warning reads:

“Clinically significant cases of liver injury have been reported in patients treated with Tecfidera in the post marketing setting. The onset has ranged from a few days to several months after initiation of treatment with Tecfidera.”

Although the updated warning label states that abnormalities from taking the medicine are resolved when the patient stopped taking the medicine, in the worst case scenario, some required hospitalisation. So far, none of the reported cases have resulted in liver failure, liver transplant, or death, according to the pharmaceutical company.