After receiving reports of Zinbryta encephalitis cases, the FDA is reviewing the link between the multiple sclerosis drug and the inflammation condition.

Three Zinbryta encephalitis cases have been reported in the United States and even more reported in Europe, according to Sandy Walsh, a spokesperson for the U.S. Food and Drug Administration (FDA). The FDA is reportedly using worldwide data for its review, including an investigation done by the European Medicines Agency.

Since the drug’s release, Zinbryta has had a “complex safety profile”, Walsh told the New York Post. About 1,200 cases of safety issues were reported to the FDA’s Adverse Event Reporting System since its release in 2016. 626 of the reports were serious cases, 25 of which ended in death.

The FDA recognizes that their system is based on voluntary reporting of issues and does not give an accurate idea of how many patients experience problems. However, the system often provides the FDA with a base on which to investigate.

FDA and Voluntary Recalls

Following the Zinbryta encephalitis cases, Biogen and AbbVie, the drug’s manufacturers, announced that they are voluntarily recalling the drug from global markets. According to Walsh, many voluntary recalls occur after the FDA takes regulatory action, but in this case FDA action was not necessary.

The FDA approval system aims to ensure the safety of a drug before it is released to the public. However, Dr. Caleb Alexander, co-director of the Johns Hopkins Center for Drug Safety and Effectiveness, told the New York post that safety problems can still emerge when a drug is released to market. “When drugs are approved we know relatively little about their safety in the real world, and that’s the nature of our regulatory system,” Alexander said.

Zinbryta was approved by the FDA in 2016 as a treatment for relapsing multiple sclerosis. The drug is typically prescribed to MS patients who did not respond well to two or more other drugs for the condition.

Zinbryta works by binding to immune cells and reducing the activity of cell attacking the immune system. However, since its release, Zinbryta encephalitis cases have been reported in the United States and Europe.

Encephalitis is an inflammation of the brain characterized by flu-like symptoms including fever, headache, muscle pain, weakness, nausea, light sensitivity, and more. In severe cases, encephalitis can lead to confused thinking, seizures, problems with senses and movement, permanent disability, and death.

Immune-mediated disorders and infection are common causes of encephalitis and both are known side effects of Zinbryta. Zinbryta encephalitis cases are thought to be related to these side effects.

If you or a loved one experienced encephalitis following Zinbryta use, you may be eligible to participate in a free Zinbryta lawsuit investigation. Under federal law, pharmaceutical companies are required to list any and all symptoms on their packaging and alert the FDA to any changes. Legal action could potentially be taken against Zinbryta manufacturers to hold them accountable for Zinbryta encephalitis cases and side effects not included on their warning labels.

A Zinbryta lawsuit could recover compensation for medical expenses, loss of wages, pain and suffering, permanent disability, wrongful death, and more.