Zinbryta, a drug used to treat Multiple Sclerosis (MS), has been beleaguered with claims of dangerous side effects since its U.S. commercial debut less than two years ago.

The U.S. Food and Drug Administration (FDA) approved Zinbryta in May 2016 but has recently been called upon by the medication’s manufacturers to assist in the medication’s voluntary withdrawal from the market.

This recall action taken by Biogen and Abbvie is because of reported encephalitis symptoms being linked to the MS drug.

The European Medicines Agency (EMA)—Europe’s equivalent to the FDA—was the first to look into these reports of encephalitis symptoms.

Three cases of death and nine other purported instances of inflammatory conditions affecting brain tissue were analyzed by the EMA. The 12 total cases of patients suffering encephalitis symptoms were just what was reported and may be just the tip of the iceberg.

Biogen and Abbvie did not need to be forced by FDA action to recall Zinbryta, as recently indicated by a company representative. They are working with the federal drug oversight agency to remove the drug from commercial circulation within a safe timeline for current patients.

Because of these reports of encephalitis symptoms and other allegedly linked Zinbryta side effects connected to the liver and skin, the medication will only be prescriptible until the end of April 2018.

The voluntary recall action was announced early in March giving medical professionals time to transition their MS patients to alternative drug treatments.

Additionally, Zinbryta will not be given as part of any clinical trial studies now or after the termination date of April 30. Prior to this recall action taken by the drug’s manufacturer, other steps were initiated to mitigate risk from purported adverse reactions such as encephalitis symptoms.

The first was the creation of a black box warning’ that appears on its label. Black box warnings are the strongest label warnings available. Zinbryta’s warning alerts doctors and patients of the possibility of liver injury and other immune system disorders, but doesn’t acknowledge the possibility of experiencing encephalitis symptoms or skin disorders such as Stevens-Johnson Syndrome.

Another effort by the company led to Zinbryta being available on a restricted access basis only. It was then recommended to be prescribed when an MS patient had not responded to treatment with at least two other possible drug protocols.

What Are Encephalitis Symptoms?

Encephalitis is a swelling of brain tissue as opposed to meningitis which affects the membranes covering the brain. It can be caused by different types of infection and immune system malfunction. It symptoms look like influenza on the milder end and, at its peak, something much more severe with seizures, hallucinations, delusions or delirium.

If you or a loved one took Zinbryta and experienced injury, you may have a legal claim or be able to be part of a class action lawsuit investigation.