Zinbryta is a long-acting injection that was approved in the U.S. and Europe in 2016 for treating relapsing forms of multiple sclerosis (MS).
The European Medicines Agency (EMA) recommended recalling Zinbryta after 12 patients developed inflammatory brain disorders, such as encephalitis and meningoencephalitis. The agency warned:
Zinbryta may also be linked to severe immune reactions affecting several other organs.”
Those other immune system disorders include blood dyscrasias, thyroiditis or glomerulonephritis.
Zinbryta has also been linked to severe hypersensitivity reactions, inflammatory disorders, and immune toxicity.
The manufacturers, AbbVie and Biogen, immediately pulled Zinbryta off the market worldwide on the same day the EMA issued warnings.
The U.S. Food and Drug Administration (FDA) has taken no action and is still reviewing whether the reports of encephalitis from Zinbryta were a result of known side effects, or some other cause.
In the U.S., Zinbryta already carries a “Black Box” warning against its use in patients with liver problems. Zinbryta is linked to unpredictable, potentially fatal liver injury for up to 6 months after stopping treatment.
No new patients should start treatment with Zinbryta, according to the EMA. Healthcare professionals should immediately contact patients who are on Zinbryta, stop their treatment and consider alternatives.
Patients stopping treatment must be followed up for at least 6 months due to the risk of fatal liver injury and other immune system disorders.