The European Medicines Agency (EMA) recently warned that the risks associated with multiple-sclerosis (MS) medication Zinbryta (daclizumab) outweighed its benefits. This, following the worldwide recall of the drug back in March 2018.
The drug received FDA-approval in May 2016 for the treatment of patients with relapsing forms of MS. The drug was only intended to be used in patients in which other forms of treatment were ineffective.
Reports Link Zinbryta With Dangerous Immune Disorders Prompting Recall
The problem with the drug is that it can cause serious immune reactions affecting the brain, liver, and other organs. Back in March, the EMA recommended the immediate recall of the drug after becoming aware of 12 reports of inflammatory brain disorders, including encephalitis and meningoencephalitis. Most of the reported problems occurred within eight months of the patients beginning treatment with Zinbryta, and three of the cases were fatal.
Following a review of the issue, the EMA recommended doctors immediately contact their patients about the drug, and consider alternative treatments. The manufacturers, Biogen and AbbVie, announced their worldwide recall of the drug about the same time, and cancelled all clinical studies related to it.
The FDA announced in March 2018 that it was working with Biogen and AbbVie to withdraw Zinbryta from the U.S. market, and noted that the drug companies had started notifying health care professionals and patients. The drug remained available until April 30, 2018.
In 2017, the EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) found that unpredictable and potentially fatal immune-mediated liver injury could occur with the drug for up to six months after stopping treatment.
PRAC Confirms that Zinbryta Risks Outweigh the Benefits
The European Commission requested an additional review of Zinbryta in February 2018, which is now completed. The PRAC has confirmed that Zinbryta “poses a risk of serious and potentially fatal immune reactions affecting the brain, liver, and other organs.”
PRAC also reported that patients could continue to be at risk even several months after stopping treatment, and there is no way to tell which patients would be affected. The conclusion was the same—the risks outweighed the benefits of using the drugs.
To date, over 10,000 patients have been treated with Zinbryta. Though early clinical trials showed that the drug was effective at reducing relapse rates and MS lesions, even then there was evidence that it could also cause serious liver injury and immune conditions.
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