Following a market withdrawal of Zinbryta amid reports of Zinbryta encephalitis, the FDA has taken an active role in the withdrawal process along with the manufacturers.

On March 14, 2018, the U.S. Food and Drug Administration announced that it would continue to work with Zinbryta manufacturers Biogen and AbbVie in their withdrawal of the multiple sclerosis drug following reports of Zinbryta encephalitis.

“As a result [of the withdrawal], 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 said in the statement.

Due to the withdrawal, no new patients are being prescribed Zinbryta. “The company has begun notifying health care professionals and patients, and the drug will be available for patients as needed until April 30, 2018,” read the FDA statement.

Zinbryta (daclizumab) is a drug used for the treatment of multiple sclerosis and was often prescribed to patients who did not respond to two other multiple sclerosis drugs. Multiple sclerosis is a neurological disease which causes damage to the brain’s connections.

Symptoms vary depending on which connections are affected, but common symptoms include muscle weakness, coordination problems, visual issues, and loss of sensitivity.

Since the drug’s approval, Zinbryta has had a “complex safety profile.” A boxed warning was added to the drug’s label informing consumers of the possibility of liver problems which may require monitoring. According to the FDA’s statement, the agency monitored the drug’s safety profile throughout its time on the market.

“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 writes.

“FDA has continuously monitored adverse events associated with use of Zinbryta and has updated product labeling as new information became available.”

Safety concerns regarding the drug mounted when the European Medicines Agency (EMA) released a review following seven cases of Zinbryta encephalitis in Germany and one in Spain. Days later, the agency recommended the immediate suspension and recall of the drug after receiving twelve world reports of Zinbryta encephalitis. Of the twelve Zinbryta encephalitis cases, three resulted in death.

Encephalitis is a potentially fatal inflammation of the brain. Symptoms of Zinbryta encephalitis resemble a cold or flu, but other symptoms include seizures, muscle weakness, problems with speak or hearing, loss of sensation, paralysis and loss of consciousness.

As concern over Zinbryta encephalitis increased, drug manufacturers Biogen and AbbVie announced a worldwide recall. The companies announced that they would be working with regulatory authorities to facilitate the recall.

“Biogen believes the voluntary worldwide withdrawal of ZINBRYTA, a treatment for relapsing multiple sclerosis, is in the best interest of patients,” stated a Biogen executive. “Biogen and AbbVie continue to prioritize patient safety and the care of multiple sclerosis patients worldwide.”

Consumers prescribed Zinbryta are encouraged to speak with their doctor regarding medication changes and multiple sclerosis treatment.