Dimethyl Fumarate Linked to Liver Injury

Research Summary: Liver injury associated with dimethyl fumarate in multiple sclerosis patients

Last Friday, members of the Office of Surveillance and Epidemiology at the US FDA published a brief report in the journal Multiple Sclerosis.  This article highlighted a cluster of drug induced liver injury (DILI) in people with MS taking dimethyl fumarate (DMF), marketed as Tecfidera.

In the report, they presented information from a search of the FDA Adverse Event Reporting System (FAERS) database.  Using this data, they found 14 cases of significant liver injury that was closely associated with the use of dimethyl fumarate.  A number of other instances were also identified, however, they did not have enough evidence to directly link these to DMF use.

Of the people affected, 12 were women and 2 were men aged between 25 and 56 years old.  The level of severity of the liver injury was referred to as moderate to moderate-severe in 8 cases, and mild in the other six cases.  On average, liver injury began 101 days after beginning treatment with DMF.  However, seven of the people showed liver problems within a month of starting on DMF.  Ten people were hospitalised as a result of their liver injury, however, no fatalities or transplants were recorded.  In every case, the liver problem cleared up within days to weeks of stopping the use of DMF.

The mechanism through which DMF is causing the liver injury was not able to be determined.  The investigators suggested drug hypersensitivity, autoimmune hepatitis or an infection causing liver damage as possible causes.

The authors concluded that this study had identified a number of cases of DILI linked to the use of DMF without any other likely causes.  They have suggested that “health professionals should be alerted to possible serious liver injury in patients receiving DMF”.

If you are currently receiving DMF, it may be worth discussing this recent finding with your healthcare professional.  Liver function can be monitored through blood tests to ensure that no injury is occurring.  This study provides further evidence as to why continued safety monitoring of all MS treatments is required in real-world settings, even after clinical trials and approval.

The abstract for this study can be read in detail here.