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Zinbryta Withdrawal from U.S. Market to Be Complete April 30

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Federal drug regulators are working with health care professionals to help implement a Zinbryta recall, with a plan to remove the multiple sclerosis drug from the market in the United States by April 30, while avoiding problems for patients who need to transition to other treatment options. 

Earlier this month, Biogen Inc. and AbbVie announced that they were withdrawing Zinbryta from the market worldwide, following a number of reports of problems involving severe and potentially lethal cases of brain inflammation, including encephalitis and meningoecephalitis.

According to an FDA press release issued last week, the agency is providing assistance to help patients and health care professionals with the transition.

“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,” the FDA press release states. “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.”

Zinbryta (daclizumab) is an injection drug sold by Biogen and AbbVie, which was just introduced in 2016. The FDA has approved Zinbryta for the treatment of adult patients with relapsing forms of multiple sclerosis. Due to a risk of liver injury linked to Zinbryta side effects, the drug is currently subject to a Risk Evaluation and Mitigation Strategy (REMS) program in the U.S., and regulators only recommend it as a treatment for individuals who have failed to respond to other first-line MS drugs.

Only about 8,000 individuals worldwide have used Zinbryta, highlighting the serious brain inflammation risks with at least 12 reports known to be linked to use of the drug.

At least three Zinbryta deaths have been reported, all of which occurred in the United States, which led the FDA to launch an investigation into the reports. The agency was reassessing the drug’s safety profile when European regulators  and the manufacturers decided the drug should be pulled from the market.

The FDA is advising patients using Zinbryta not to stop without first talking with their doctor. The agency urged patients to contact their doctor immediately if they have any new or unexplained symptoms.

Patients with questions or concerns can contact the manufacturers’ service center by calling 1-800-456-2255 or by visiting the drug website at www.zinbryta.com. The FDA also urges health care professionals and consumers to report any adverse reactions to the FDA’s MedWatch adverse event reporting program.

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