Following reports of encephalitis in European markets, drug manufacturers have voluntarily initiated a Zinbryta market withdrawal, ceasing all sales and clinical studies.

Biogen and AbbVie have initiated a voluntary Zinbryta market withdrawal following European regulatory events and reports of encephalitis. On the same day that the European Medicines Agency called for an “urgent review” of Zinbryta, the drug manufacturers announced that they would be recalling the drug, ceasing all sales, and stopping any clinical studies.

Patients have been advised to not stop taking their medications without doctor supervision.

“Given the nature and complexity of adverse events being reported, characterizing the evolving benefit/risk profile of Zinbryta will not be possible going forward given the limited number of patients being treated,” the drug manufacturers wrote regarding the Zinbryta market withdrawal, according to CNN. “Therefore, Biogen and AbbVie believe it is in the best interest of patients to voluntarily withdraw worldwide marketing authorizations for Zinbryta.”

The U.S. Food and Drug Administration (FDA) has informed the public that they are working closely with the drug manufacturers during the Zinbryta market withdrawal “to help ensure a well-organized withdrawal from the market in the United States, and to ensure that healthcare professionals have the information they need to carefully transition their patients using Zinbryta to another treatment.”

Zinbryta (daclizumab) was approved by the FDA in May 2016 to treat multiple sclerosis, an autoimmune condition affecting the nervous system. Zinbryta was recommended for patients who had an inadequate response to two or more other multiple sclerosis medications.

Since its approval, Zinbryta has had a “complex safety profile”, according to the FDA. Notable Zinbryta side effects included immune injury including liver failure and immune reactions including serious, life-threatening skin reactions. In the short time the drug was on the market, Zinbryta accrued a black-box warning and numerous evaluations of risk by regulatory bodies. The inclusion of encephalitis in the drug’s side effects and the subsequent Zinbryta market withdrawal are the latest events in the drug’s tumultuous past.

Currently, twelve cases of encephalitis have been reported worldwide in patients treated with Zinbryta. Encephalitis is a condition involving inflammation of the brain and is usually caused by a bacterial infection, viral infection, or immune system disorder. Symptoms of encephalitis may vary, but common symptoms are typically flu-like and include muscle pain, fatigue, fever, nausea or vomiting, light sensitivity, and headache. More extreme symptoms may include seizures, coordination problems, disorientation, and other neurological side effects.

The condition is treated by aggressive medical intervention including anti-inflammatory drugs, antibiotics, and other medications to treat the resulting symptoms. Even after recovery, individuals may experience complications and continued symptoms. These patients may need to seek physical therapy or occupational therapy to regain physical strength and coordination.

If you or a loved one developed encephalitis after taking Zinbryta, you may be eligible to file a lawsuit against the drug manufacturers. A Zinbryta lawsuit may argue that patients were not sufficiently warned that the drug was not safe and that manufacturers should have known about the risks earlier than when they initiated the Zinbryta market withdrawal. These lawsuits may recover compensation for medical expenses, pain and suffering, loss of past and future income or earning capacity, loss of consortium, and more.