According to the U.S. Food and Drug Administration, known Zinbryta side effects gave the multiple sclerosis drug a “complex safety profile” since it was first approved.

Because of this, the medical drug and device oversight agency approved the multiple sclerosis (MS) medication under certain conditions. It was approved for commercial use on May 27, 2016 but was supposed to be reserved for patients whose disease progression had not responded to at least two other drugs on the market.

Additionally, Zinbryta side effects during clinical safety trials led the FDA to require the drug’s manufacturers Biogen and Abbvie to put a boxed warning advising patients and physicians about the risk of liver injury and other immune-related disorders.

The medication was also put on a close watch with regard to reports of adverse medical events associated with it. Because of Zinbryta side effects identified at that time—which included liver function compromise and immune disorders—it was only available through a restricted distribution system.

What is Multiple Sclerosis?

The National Multiple Sclerosis Society describes this heinous disease of the central nervous system as unpredictable. Communication between the brain and the musculoskeletal nerves are disrupted and often lead to progressive paralysis. The disease affects women more than men and it often strikes in the age range between 20 and 50.

The European Medicines Agency Warning

In early March 2018, the European Medicines Agency (EMA) alerted the public about a dozen cases of inflammatory brain disorders such as encephalitis and meningoencephalitis—inflammations of the brain and the three membrane sheaths which enclose it and the spinal cord.

According to a Pharma Times article around that time, the inflammation was identified as one of several potential Zinbryta side effects. The reporter indicated that three out of the 12 patients succumbed to the brain inflammation syndrome.

A review of the patients revealed that other organs may have been involved as well in systemic immune reactions to the MS medication. Before even completing the review in its entirety, the evidence for Zinbryta involvement was so overwhelming that the EMA recommended withdrawal of the drug from the market.

The EMA also thought it prudent, given the situation, to have batches located in hospitals and pharmacies throughout the European Union (EU) recalled.

A Voluntary Recall

In response to the warning, Biogen and Abbvie immediately initiated a voluntary recall of the MS medication globally. Clinical studies that were being undertaken at that time were abandoned due to severe concerns about subjecting enrollees to harm.

The Pharma Times report indicated that as of early March last year, about 8,000 people had been treated with the drug for MS.

Once the voluntary action was initiated, the FDA began working with the manufacturer to organize a market withdrawal that wouldn’t leave patients in the lurch. An information campaign regarding Zinbryta side effects was undertaken, so that medical professionals were well aware of some of the problems and had time to transition patients to alternative treatments.

The MS medication was available up until the last day of April 2018. Patients were encouraged not to stop taking the drug without meeting with their physicians for consult beforehand.