Zinbryta (daclizumab) is a multiple sclerosis drug which was approved by the U.S. Food and Drug Administration in May 2016. The drug was commonly prescribed for patients who hadn’t responded well to two or more other multiple sclerosis drugs.

The drug was pulled from the market due to reports of encephalitis. However, patients may be at risk for Zinbryta liver failure if they were treated with the multiple sclerosis drug.

Multiple sclerosis is an autoimmune condition in which the immune system attacks the protective sheath surrounding nerve cells in the brain and spinal cord. This degenerative condition can cause severe neurological side effects which vary depending on the affected neurological connections. Zinbryta treats multiple sclerosis by binding to immune cells and inhibiting the activity of cells which attack the nervous system.

Zinbryta Safety Profile

According to statements made by the FDA, Zinbryta has had a “complex safety profile” since its approval. This profile lead to a black-box warning regarding immune-mediated disorders and liver damage, as well as an investigation by the European Medicines Agency.

In July 2017, the European Medicines Agency considered clinical data suggesting Zinbryta liver failure and subsequently restricted the use of the drug. Their regulations restricted Zinbryta use to patients with highly active multiple sclerosis who hadn’t responded to other drugs or could not be treated with other drugs.

The European Medicine Agency’s Pharmacovigilance Risk Assessment Committee requested the restrictions after studies showed the possibility of Zinbryta liver failure. An observational study which was then ongoing had informed the Committee of the death of a patient due to Zinbryta liver failure. Four other patients involved in the study developed severe liver damage while on the drug.

According to data from the study, Zinbryta liver failure or damage occurred at varying times during treatment ranging from early on to several months after treatment ended. The Committee encouraged new restrictions in the hopes of reducing Zinbryta liver failure and damage in patients.

Under the regulations, doctors were encouraged to conduct monthly liver tests on those individuals who continued taking Zinbryta. The Agency also encouraged patients to be vigilant of potential Zinbryta liver failure symptoms, including unexplained nausea, abdominal pain, vomiting, loss of appetite, fatigue, yellowing of skin and eyes, and dark colored urine.

Currently, Zinbryta has been voluntarily taken off the market by manufacturers Biogen and Abbvie. This move followed 12 worldwide reports that the multiple sclerosis drug caused encephalitis, a deadly inflammation of the brain. Although encephalitis was the primary motivation for recalling the drug, Zinbryta liver failure and the drug’s complicated safety profile reportedly contributed to the move.

If you or a loved one suffered from Zinbryta liver failure or damage as a result of treatment with the multiple sclerosis drug, you may qualify for legal action. Zinbryta lawsuits often claim that Biogen and Abbvie failed to sufficiently warn consumers about the risks associated with their medication including liver damage, immune-mediated conditions, and encephalitis. A Zinbryta liver failure lawsuit could potentially recover compensation for medical expenses, pain and suffering, wrongful death, and more.