Revised SPCs: Tecfidera (dimethyl fumarate) 120 and 240mg gastro-resistant hard capsules

SPCs updated to warn that cases of Fanconi syndrome have been reported for dimethyl fumarate products in combination with other fumaric acid esters. Early diagnosis & discontinuation are important to prevent onset of renal impairment and osteomalacia, as it is usually reversible.

SPS commentary:

Fanconi syndrome is a defect of proximal tubule leading to malabsorption of various electrolytes and substances that are usually absorbed by the proximal tubule.


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