Daclizumab, marketed under the brand name Zinbryta, came with certain known safety issues from its inception.

So when post-market cases of encephalitis started showing up in multiple sclerosis (MS) patients taking Zinbryta, it came as no surprise that Biogen and Abbvie, the drug’s manufacturers, would initiate a voluntary Zinbryta market withdrawal.

This voluntary Zinbryta market withdrawal was announced by the company on March 2, 2018. The U.S. Food and Drug Administration (FDA) has been working with the company to help make the transition smooth for physicians and patients by allowing medical professionals time to get clients situated on other medication regimens. The Zinbryta market withdrawal was slated to be complete by April 30, 2018.

Zinbryta’s Complicated History

Zinbryta was approved by the FDA on May 27, 2016. Although it was given the go-ahead by the drug oversight agency, physicians were encouraged to prescribe the medication to MS patients whose disease progression hadn’t been deterred by at least two other known treatment alternatives.

Later, a black box warning was added to the label because of the risk of liver injury or severe immune system responses such as Stevens Johnson Syndrome, a dangerous skin reaction that can leave the body vulnerable to systemic infection.

EMA Investigation Precedes Zinbryta Market Withdrawal

The European Medicines Agency (EMA), Europe’s equivalent to the FDA, started investigating a dozen cases of inflammation involving brain tissue or membranes surrounding the brain that occurred in patients taking Zinbryta. Of the 12, three patients succumbed to their symptoms.

Encephalitis, or swelling of the brain tissue, is usually linked to bacterial or viral infections but can also be related to an immune system malfunction. Meningitis affects the brain’s encasing membranes and is also typically related to infection.

The investigation was unable to identify any signs of infection, but ingestion of Zinbryta was a common factor.

What are Symptoms of Encephalitis?

Symptoms of encephalitis, like so many other physical ailments, can start out with flu-like symptoms. The person may experience unexplained fever, joint and muscle pain, overall weakness and exhaustion and nausea coupled with vomiting.

As the condition worsens, the sufferer can become very confused or even have auditory or visual hallucinations. Seizures are also not uncommon.

The Response

Statistically speaking, a dozen cases presents a relatively small risk, so the FDA responded to the voluntary Zinbryta market withdrawal by allowing it to remain available for nearly two months beyond the manufacturer’s announcement.

It was said from the beginning of the action, however, that new patients wouldn’t be enrolled in any clinical safety studies involving the MS drug.

Now that summer is upon us and the Zinbryta market withdrawal is complete, many are asking what Biogen and Abbvie’s responsibility to those patients that suffered encephalitis, other immune system reactions, injuries to the liver, or Stevens Johnson Syndrome.

While their voluntary action is admirable, it isn’t enough for those that have endured their own pain and suffering or that of a loved one. Filing a lawsuit to recover funds to pay medical bills might be the answer.