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Drug Safety Alerts
Zinbryta® Withdrawal
3/22/18
On March 22, 2018, Biogen and Abbvie announced a voluntary withdrawal of Zinbryta® (daclizumab), a multiple sclerosis (MS) drug, from the global market, noting concern about the drug’s evolving benefit/risk profile. As a result, the United States Food and Drug Administration (FDA) is working closely with the manufacturers to help ensure a well-organized withdrawal from the market in the United States, and to ensure that health care professionals have the information they need to carefully transition their patients using Zinbryta to another treatment. No new patients will start taking Zinbryta or participate in clinical studies. The company has begun notifying health care professionals and patients, and the drug will be available for patients as needed until April 30, 2018.
Patients using Zinbryta should not stop their medication without talking with their doctor and should contact their doctor immediately if they have any new and unexplained symptoms. The FDA understands that this may be a difficult situation for some patients and will continue to work closely with the manufacturers throughout the withdrawal process.
The complex safety profile of Zinbryta has been recognized since the time of the FDA‘s approval. The drug’s safety profile led to an indication of use generally limited to patients who have had an inadequate response to two or more multiple sclerosis drugs, to a boxed warning about the risk of liver injury and of other immune-mediated disorders, and to a Risk Evaluation and Mitigation Strategy making the drug only available through a restricted distribution program. The FDA has continuously monitored adverse events associated with use of Zinbryta and has updated product labeling as new information became available.
CVS/caremark Response: Please note: This product is carried by the CVS Specialty Pharmacies only. Because of this action, CVS Specialty is sending letters to members who received this product through CVS Specialty Pharmacies and their physicians.
For more information about this issue, health care providers may contact the Biogen service center at 1-800-456-2255 or visit https://www.zinbryta.com/.
You may also call the FDA consumer inquiry line at 1-888-INFO-FDA (1-888-463-6332) or visit https://www.fda.gov/.