If you have suffered from Zinbryta encephalopathy, you could be eligible to participate in a class action lawsuit investigation.

Zinbryta (daclizumab) was taken off the market by drug makers Biogen and Abbvie in March 2018 due to reports of Zinbryta encephalopathy and meningoencephalitis. Of the dozen reported cases of Zinbryta encephalopathy, three reportedly have resulted in death.

Zinbryta was approved by the FDA in May 2016 to treat adults suffering from relapsing types of multiple sclerosis (MS). It was considered a third-line drug, meaning that patients generally only received a Zinbryta prescription after two or more other MS drugs failed to work well.

Patients diagnosed with MS experience the body’s immune system attacking and damaging the protective covering around nerve cells in the brain and spinal cord. Zinbryta worked by binding together with the immune system’s cells to help stop them from attacking the central nervous system.

What is Zinbryta Encephalopathy?

Encephalitis is marked by inflammation of the brain tissue. Most cases are the result of a bacterial or viral infection, but in some cases, an immune system dysfunction can cause encephalitis.

Zinbryta encephalopathy induced by the medication is marked by the symptoms seen in other encephalitis sufferers:

• Muscle pain
• Muscle weakness
• Fever
• Fatigue
• Coordination issues
• Mental confusion or disorientation
• Hallucinations or delirium
• Nausea and vomiting
• Irritability
• Light sensitivity
• Headaches
• Seizures
• Stiff Neck
• Other

Although the FDA has indicated it is working with Biogen and Abbvie “to help ensure a well-organized withdrawal from the market in the United States, and to ensure that healthcare professionals have the information they need to carefully transition their patients using Zinbryta to another treatment,” the Zinbryta recall is voluntary in the United States.

Upon Biogen and Abbvie’s initiation of the recall, the FDA announced that “no new patients will start taking Zinbryta or participate in clinical studies.” The FDA also ensured the drug was accessible to patients who needed it through April 30, 2018. By then, the patients needed to consult with their doctors to establish alternative therapies.

Zinbryta encephalopathy is only one of the possible severe adverse side effects of the drug. Shortly after it went on the market, the FDA added a black box warning regarding the increased risks of serious liver injuries and other immune system-related disorders. It was at that same time that Zinbryta was recommended to be tried in patients who only had not responded adequately to two or more other MS medications.

Zinbryta also became designated as a drug that was only available through a restricted distribution program monitored by the FDA and known as the Risk Evaluation and Mitigation Strategies (REMS). This program began in 2007 with a new law that allowed the FDA to establish “a safety strategy to manage a known or potential serious risk associated with a medicine and to enable patients to have continued access to such medicines by managing their safe use.”

If you or someone you love has experienced Zinbryta encephalopathy or other serious Zinbryta adverse side effects, you could be eligible to participate in this investigation.