Drugmakers AbbVie and Biogen have issued a recall over concerns about Zinbryta liver failure and other complications related to the medication.

In addition to concerns over Zinbryta liver failure, the drug used to treat multiple sclerosis (MS) has also been implicated in autoimmune disorders, dermal reactions, and serious brain inflammation. The voluntary recall was issued after a number of cases of encephalitis related to Zinbryta were reported in Europe.

About Zinbryta

Zinbryta is the brand name for daclizumab, a prescription medication that was used to treat adult patients with relapsing MS. The mechanism of action is not precisely known. However, it has the effect of inhibiting the action of T-cells, immune cells that attack myelin, the substance that insulates the neural “wires” that connect brain cells.

Daclizumab was first approved by the FDA in 1997 as an anti-rejection drug for kidney transplant patients, used in combination with immunosuppressants and anti-inflammatories.

In 2016, the medication received FDA approval for treating patients suffering from “relapsing multiple sclerosis,” in which the patient experiences intermittent, increasingly severe “attacks” or episodes of the disease, following remission periods during which symptoms may vanish. Patients would receive a dose of the medication once every four weeks. 

Zinbryta Liver Failure and More

During clinical trials of daclizumab for patients with relapsing MS, researchers noted Zinbryta liver failure and complications in 18 percent of subjects. 37 percent suffered skin rashes, while infections were seen in 65 percent. At that time, no fatalities were seen in relation to treatment with the drug, however. Nonetheless, when the FDA granted approval, it warned that because of the risk for Zinbryta liver failure and autoimmune reactions, the drug should be used only after other treatments had failed. Despite its approval by both the FDA and the European Medicines Agency (EMA), severe restrictions were placed on the use of Zinbryta. Eventually, the FDA began requiring a “black box” warning for all package labeling, used when medication is deemed to have particularly serious and life-threatening side effects. Shortly after the EMA called for an “urgent review” of Zinbryta and recommended that all use of the medication be suspended, Biogen and AbbVie announced that they would take the product off the market.

“In The Best Interest of Patients”

In a press release, both companies announced that further evaluation of Zinbryta’s “complex and evolving benefit/risk profile… will not be possible going forward given the limited number of patients being treated.” Dr. Alfred Sandrock, Chief Medical Officer at Biogen, said the recall of the drug was “in the best interests of patients.”Since approving Zinbryta in May 2016, the FDA has received approximately 1,200 adverse event reports. More than half of the cases were serious; nearly 4 percent of those patients died. 

Will Zinbryta Liver Failure Result in Legal Action?

The drug is currently at the center of a wrongful termination claim by a former Biogen employee who claims she was fired in retaliation for expressing concerns about the marketing of Zinbryta for “off-label” purposes. Patient advocates are investigating possible legal claims related to Zinbryta liver failure, encephalitis and other injuries and deaths on behalf of victims and their families.