FDA Helping with Zinbryta® Withdrawal
As a follow-up to MSAA’s online article, “Zinbryta® Withdrawn from Marketplace,” MSAA is alerting individuals taking Zinbryta® (daclizumab) to additional information on the withdrawal. On March 14, 2018, the United States Food and Drug Administration (FDA) issued a press release to assist with the withdrawal of Zinbryta from the market in the United States. They want to support a “well-organized withdrawal” and to ensure that physicians have the information they need to “carefully transition their patients” who are currently taking Zinbryta to another disease-modifying therapy for MS.
In this press release, the FDA states:
- As needed, Zinbryta will be available for individuals who are already taking the medication until April 30, 2018.
- No new patients may begin taking Zinbryta or participate in clinical studies involving this medication.
- Individuals taking Zinbryta should not stop their medication until they speak with their doctor.
- Anyone taking Zinbryta needs to contact his or her doctor immediately if experiencing any new or unexplained symptoms.
Additionally, the FDA reports that the European Medicines Agency recalled Zinbryta following 12 reports of serious inflammatory brain disorders worldwide (four more cases than initially reported by the press in early March). The FDA also notes that it is conducting a review of similar events and directs anyone with questions or concerns about the withdrawal to contact Biogen’s service center at (800) 456-2255 or their website at www.zinbryta.com. Anyone needing to report adverse reactions or quality problems with Zinbryta may do so through the FDA’s MedWatch program; details are given at the conclusion of the FDA’s press release.
For general information or to speak with a trained Client Services Specialist, please call MSAA’s Helpline at (800) 532-7667, extension 154. Questions to MSAA’s Client Services department may also be emailed to MSquestions@mymsaa.org.
Written by Susan Wells Courtney, MSAA Senior Writer
Reviewed by Dr. Jack Burks, MSAA Chief Medical Consultant