Less than a week after announcing that they were “urgently reviewing” AbbVie and Biogen multiple sclerosis drug Zinbryta on safety concerns, European regulators are recommending an immediate suspension and recall of the product.
The European Medicines Agency announced the move on Wednesday, citing 12 reports of serious inflammatory brain disorders worldwide, including encephalitis and meningoencephalitis. Three of those cases led to patient deaths, the agency noted.
And that’s not all. “Zinbryta may also be linked to severe immune reactions affecting several other organs,” the body warned.
The suspension and recall follow AbbVie and Biogen’s decision to yank the drug from markets around the globe. The pair made the call on Friday, the same day the EMA unveiled its review.
Friday wasn’t the first time Zinbryta had stirred up safety concerns, though. In the U.S., the drug carried a black-box warning against use in patients with liver problems, and in Europe, regulators had placed limits on its use and required strict liver monitoring.
For now, the EMA advised, doctors should contact their Zinbryta patients immediately to stop their treatment and look for an alternative therapy. Once stopping therapy, patients should be followed up with for at least 6 months, it said.