Biogen and Abbvie—manufacturers of the now commercially unavailable multiple sclerosis (MS) medication—voluntarily chose to begin Zinbryta market withdrawal in early March of this year. Purportedly, the Zinbryta market withdrawal was to be complete by the last day of April, giving physicians time to transition their patients to another treatment regimen.

The Zinbryta market withdrawal was always voluntary on the part of the pharmaceutical company, but it was initially and powerfully suggested by the European Medicines Agency (EMA)—our counterpart to the U.S. Food and Drug Administration (FDA)—after they had carefully pored over the records of a dozen patients that had developed a variety of inflammation-based brain disorders while taking the MS drug.

During the Zinbryta market withdrawal transition period from March 3 to April 30, no new patients were to be started on the drug, which was not recommended as a first choice to physicians in the first place. Clinical safety studies underway in early March were immediately brought to a halt while investigations continued to determine whether the connection between the drug and encephalitis—an overall inflammation of the brain tissue.

Zinbryta Concerns at its Outset

Zinbryta was approved by the FDA on May 27, 2016, so it has been on the market in the U.S. for just shy of two years. When it was given the green light by the drug oversight agency, a strong recommendation was issued with it that physicians only prescribe it when a given patient has shown no response on at least two other possible MS medications.

The reason for these hesitancies on the part of the FDA was because clinical trials had already flagged the medication for potential adverse effects on the liver and disorders related to the immune system of the body such as erythema multiforme, a precursor to two serious skin disorders known as Stevens-Johnson Syndrome (SJS) and Toxic Epidermal Necrolysis (TEN) which can cause burns and herald infections which can turn fatal.

When Zinbryta was approved in the U.S., it was released with the FDA’s strongest warning available, known as a “black box warning,” a side effects warning made visible on the label by being set off by bold black type and surrounding box. Authorities referred to the MS drug as having a “complex safety profile”.

Encephalitis Cases

Of the dozen cases of encephalitis that the EMA reviewed, three resulted in the death of the patient. A causal link between the patients use of Zinbryta has not been confirmed, but the circumstantial evidence was enough to set off alarms in authoritative agencies and warrant the complete Zinbryta market withdrawal.

Encephalitis is most often brought on by a bacteria or virus. In rare cases such as this—where a medication is involved—it points to the malfunctioning of the immune system which is already compromised in an MS patient. MS occurs when the body’s infection fighters attack healthy tissue—namely the nervous system and the sheath that protects the brain, spinal cord, and nerve cells. The sheath allows for smooth communication between the brain and the muscular-skeletal system.

If you or a loved one took Zinbryta and were hospitalized for encephalitis or other issues related to the skin, immune system, or liver, you may have a legal claim that can help you recover compensation for your suffering and to pay medical bills.