Zinbryta, a drug that is used to treat multiple sclerosis (MS), has been implicated in at least a dozen cases of encephalitis worldwide—some of which had a fatal outcome. Other purported Zinbryta side effects include liver failure and skin reactions that are the precursors to Stevens Johnson Syndrome.

These alleged Zinbryta side effects are so significant that the drug’s manufacturer’s, Biogen and Abbvie, have voluntarily decided to remove the medication from the marketplace with the cooperation of the U.S. Food and Drug Administration (FDA).

Although Zinbryta was approved by the FDA on May 27, 2016, a recommendation was issued early on to not use it as a first line method of treatment for MS. It has usually been saved for patients that have not responded to at least one, if not two, other drug protocols.

A black box warning regarding the Zinbryta side effects of liver injury and related immune system disorders was actually put on the packaging fairly soon after it became commercially available in the U.S.

MS is an immune system disorder. In it, the fighting mechanism attacks the sheath around cells of the brain, spinal cord, and nerves as if they were invading foreign bodies.

The active ingredient in Zinbryta is supposed to slow this self-attacking mechanism by attaching itself to immune system cells. The purported Zinbryta side effects of liver failure, skin reactions, and encephalitis, however, indicate that something goes awry in the immune system of a certain percentage of patients.

According to an article by the European Medicines Agency (EMA), Europe’s equivalent to our FDA, the EMA recommended Zinbryta be removed from the market after reviewing a dozen cases of inflammatory brain disorders connected to its use.

The other alleged Zinbryta side effects on organ systems were also of serious concern. Biogen and Abbvie didn’t wait for legal pressure to follow this recommendation before acting. They immediately stopped clinical studies of the drug and requested a voluntary withdrawal of marketing authorization.

The FDA Plans Zinbryta Exit Strategy

The MS drug will be available commercially only until April 30, 2018.  The drug’s manufacturers are working with the FDA to slowly withdraw the treatment while the drug oversight agency investigates alleged cases of encephalitis for clear evidence of a connection. All clinical studies have been stopped and no new patients have been started on the drug.

While encephalitis is often caused by a bacterial or viral infection, some instances are believed to be related to immune system malfunctioning. Encephalitis is a swelling of the brain tissue and is often reflected in symptoms that are similar to the flu.

These symptoms include muscle and joint pain, fever, weakness, headache, and upset stomach with vomiting. If these symptoms worsen, a sufferer can experience seizures, hallucinations, and mental disorientation.

While Biogen and Abbvie have voluntarily initiated the U.S. market withdrawal, they may not have adequately warned U.S. patients of the risk of Zinbryta side effects of brain inflammation, liver failure or skin disorders. If you were prescribed this drug and experienced any of these symptoms, you may have a legal claim.