A class action investigation has been launched after numerous patients reportedly developed autoimmune encephalopathy soon after being prescribed multiple sclerosis (MS) drug Zinbryta (daclizumab).

Manufacturing companies Biogen and Abbvie recently announced they were voluntarily withdrawing Zinbryta from the market, both in the United States and internationally, after receiving alleged reports of autoimmune encephalopathy.

Autoimmune encephalopathy is a condition in which the brain tissue becomes inflamed. It can be caused by a bacterial infection or other environmental factors. However, this condition can form an autoimmune attack, in which the body attacks its own brain.

This is a potentially fatal condition with at least 12 cases of Zinbryta encephalitis reported worldwide. Three of those cases were fatal. The voluntary market withdrawal was announced on March 2, 2018, with the companies stating they had received injury reports worldwide involving encephalitis and meningoencephalitis.

It is important to note that on the same day of the Zinbryta recall announcement, the European Medicines Agency (EMA) issued an “urgent review” of the medication after seven cases of brain inflammation conditions had been reported in Germany and one case in Spain.

These cases reportedly contained incidents of autoimmune encephalopathy, with the European Commission initiating a review of daclizumab after a request was sent from the European Commission on Feb. 26, 2018. The initial review is being conducted by Pharmacovigilance Risk Assessment Committee (PRAC), which is the organization responsible for evaluating the safety profiles of medications meant for human use.

This essentially means that the committee evaluates the risks and benefits the drugs present to the public, which will help European Union determine whether or not Zinbryta should continue to be prescribed. The EMA stated the doctors in the European Union would be updated when this information became available.

As of now, European medical authorities are recommending that Zinbryta be immediately suspended and recalled from the market to prevent other cases of autoimmune encephalopathy. European health officials also recommend that doctors contact any current Zinbryta patients immediately, and prescribe alternative treatment.

Current Zinbryta patients are encouraged to contact their doctors immediately, and to report any unusual symptoms.

Overview of Zinbryta Complications

Zinbryta was approved by the FDA on May 16, 2016, to treat adults with persistent multiple sclerosis after other treatment drugs have failed. Zinbryta worked by binding immune cells and reducing their activity, which lessens the effects of the autoimmune disease.

Patients with multiple sclerosis suffer from constant problems with their central nervous system, in which the body’s immune system becomes confused and attacks the cells surrounding the brain and spinal cord. At this point in time, over 8,000 patients have been prescribed Zinbryta.

However serious side effects have been linked to Zinbryta since its release in 2016, with the medication getting a black box warning describing the potential liver damage and other autoimmune problems including:

• Autoimmune Encephalopathy
• Liver Failure
• Serious Skin reactions like Stevens-Johnson Syndrome (SJS)

The FDA stated that Zinbryta had a “complex safety profile”, which led to a Risk Evaluation and Mitigation Strategy that greatly restricts how the drug is distributed.