FDA adds warning to Tecfidera label after patient death

The US Food and Drug Administration has issued a warning that a patient with multiple sclerosis who was being treated with Tecfidera (dimethyl fumarate), from US biotech major Biogen Idec (Nasdaq: BIIB), developed a serious brain infection called PML and later died.

The FDA has consequently added information describing this case of PML, or progressive multifocal leukoencephalopathy, to the Tecfidera drug label. The FDA said the patient who died was not taking any other drugs that affect the immune system or drugs that are thought to be associated with PML. This is the only confirmed case of this rare and serious brain infection reported in patients taking Tecfidera.

The FDA advised patients taking Tecfidera to contact their health care professionals immediately if they experience symptoms that concern them, such as new or worsening weakness; trouble using their arms or legs; or changes to thinking, eyesight, strength or balance. Symptoms of PML are diverse and may include progressive weakness on one side of the body, clumsiness, vision problems, confusion, and changes in thinking, personality, memory, and orientation. The progression of deficits can lead to severe disability or death. Health care professionals should stop Tecfidera if PML is suspected.