Due to reports of Zinbryta encephalitis linked to a popular multiple sclerosis medication,  Zinbryta was voluntarily recalled off the markets by the drug’s manufacturers Biogen and Abbvie.

Following reports of adverse side effects including Zinbryta encephalitis, the manufacturers announced on March 2, 2018 that they were voluntarily recalling Zinbryta from international markets. Adverse side effects associated have included serious skin reactions, liver failure, and serious inflammatory brain disorders, which includes encephalitis and meningoencephalitis.

Worldwide, there have been at least 12 cases of Zinbryta encephalitis reported. Of these reports, three of these cases have resulted in death.

Overview: Zinbryta Encephalitis

Zinbryta was approved by the U.S. Food and Drug Administration (FDA) in May 2016. According to the manufacturers of the drug, Biogen and AbbVie, the voluntary recall for Zinbryta was the result of safety concerns associated with the medication. They cited that “it is in the best interest of patients to voluntarily withdraw worldwide marketing authorizations,” for the medication.

Prior to the voluntary recall announcement made by the companies, the European Medicines Agency had just previously stated that following cases of inflammatory brain disorders in patients taking Zinbryta, that they were “urgently reviewing” the drug.

In Germany, there have been reported cases of Zinbryta encephalitis, including seven turning up, and one in Spain.

Patients who are taking Zinbryta are being asked by the drug manufacturers to speak to their physicians regarding any concerns or questions that they may have and how they should pursue coming off the medication. Additionally, there will need to be collaborative work between the two companies and healthcare providers and regulators.

Safety precautions already surrounded Zinbryta before the drug’s voluntary recall. A black box warning, the FDA’s most serious kind of warning, had been placed on the drug’s labels by the FDA. A risk management program was also added in the U.S.

In Europe, regulators limited the drug’s use and required there to be constant and strict liver monitoring.

Since its arrival on the market, Zinbryta adverse effects have plagued the drug. Complications associated with the drug have included:

• Encephalitis and other serious immune reactions
• Serious liver injury, liver failure, and other complications
• Skin irritations including early forms of Stevens Johnson Syndrome (SJS), which can turn into Toxic Epidermal Necrolysis (TEN). It is a dangerous, life-threatening disorder that affects the skin and resembles severe skin burns.

Zinbryta encephalitis is a very serious complication that may result from Zinbryta drug use. It is an inflammation of the brain tissue and may be the result of an immune system disorder. It may also be caused by a viral or bacterial infection. Although some people may exhibit no symptoms, common signs may include:

• Fatigue
• Fever
• Muscle pain or weakness
• Coordination problems
• Nausea or vomiting
• Headache
• Stiff neck
• Irritability
• Disorientation or mental confusion