The FDA has added a new warning for liver injury to the label of popular multiple sclerosis drug Tecfidera.
By Laurence Banville
The US Food & Drug Administration has warned patients and healthcare professionals of a potential link between the multiple sclerosis drug Tecfidera and liver injuries, according to Reuters. In a press release published Wednesday, January 25, 2017, drug manufacturer Biogen Inc. announced a slate of new labeling changes to address a possible association between Tecfidera and at least 14 cases of liver injury, all of which resolved after patients were taken off the medication.
Tecfidera Linked To Liver Injuries, HospitalizationDespite their recovery, several patients required hospitalization, Biogen said, although none of the liver problems led to liver failure, transplant or death. As the drug's new warning notes, symptoms of liver injury can include significant increases in the serum level of aminotransferases and bilirubin. Biogen and the FDA finalized the drug's warning label modifications on January 19, just 16 days after a report in the Boston Business Journal revealed that the blockbuster MS pill's price had been hiked by 8%, as the Boston Business Journal has reported.
"Clinically significant cases of liver injury have been reported in patients treated with Tecfidera in the postmarketing," the warning states. "The onset has ranged from a few days to several months after initiation of treatment with Tecfidera."
MS Drug Previously Associated With Brain InfectionTecfidera was approved on March 27, 2013 for the treatment of adults with relapsing forms of multiple sclerosis (MS), after two clinical trials showed that patients on Tecfidera experienced fewer MS relapses than patients taking a placebo. One study also suggested that the drug, which relies on the active ingredient dimethyl fumarate, could reduce the progressive disability often associated with multiple sclerosis. Today, Tecfidera is the world's leading oral treatment for multiple sclerosis. Around 23,000 people are currently prescribed the medication, a Biogen spokesperson told Reuters.
In 2014, the FDA warned physicians that a patient being treated with Tecfidera had developed a rare and serious brain infection known progressive multifocal leukoencephalopathy (PML). As a result, the federal agency updated Tecfira's label with a new warning.