(RxWiki News) A multiple sclerosis treatment is being withdrawn from the market, according to the US Food and Drug Administration (FDA).
These potential safety problems have been noted ever since the drug’s approval. These concerns led to a boxed warning for the risk of liver injury and other immune-mediated disorders. In addition, daclizumab was only available through a restricted distribution program, according to the FDA.
The European Medicines Agency announced a recall of Zinbryta after it received 12 reports of serious inflammatory brain disorders. As a result, the FDA is conducting a similar review. Biogen is working closely with the FDA on the withdrawal timeline for daclizumab.
If you are currently taking Zinbryta, do not stop your medication without speaking with your doctor, the FDA recommended. As always, contact your health care provider immediately if you notice any new and unexplained symptoms, the agency noted.
Furthermore, if you are currently taking daclizumab, the FDA recommended discussing a new treatment plan with your health care provider as soon as possible.
The manufacturers of Zinbryta have begun notifying the medical community of these safety concerns. Daclizumab will continue to be available as needed until April 30, 2018, according to the FDA.