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MS medication withdrawn because of safety concerns


 

Citing concerns about safety, Biogen and AbbVie announced March 2 that they will be withdrawing daclizumab (Zinbryta) from worldwide markets. Daclizumab has known risks, so it was usually prescribed only for people with relapsing multiple sclerosis who had tried two or more other medications that hadn’t worked well enough.

Reports of inflammatory encephalitis and meningoencephalitis led the European Medicines Agency to initiate an Article 20 referral procedure. In such referrals, a medicine or class of medicines are scientifically assessed because of concerns over safety or quality.

However, Biogen and AbbVie concluded that, because of the complex nature of these reports and how few patients were taking daclizumab, it would be difficult to characterize the nature of the medication’s harms and benefits, so the companies instead have decided to withdraw the medication from the market.

On March 14, the Food and Drug Administration announced that it is conducting a review of similar adverse event reports it has received.

The drug will continue to be available to patients until April 30, 2018. Patients taking daclizumab should not stop taking the drug without talking to their doctor and should contact their doctor if they have any new or unexplained symptoms, the FDA said. More information can be found in the press release .

cpalmer@frontlinemedcom.com

**Story updated 3/14/2018.

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