The multiple sclerosis drug Zinbryta has been voluntarily recalled from the worldwide market due to reports of encephalitis and meningoencephalitis.

The voluntary recall was announced by Biogen and Abbvie, the drug’s manufacturers, on March 2, 2018. The multiple sclerosis drug was voluntarily recalled due to reports linking Zinbryta to serious inflammatory brain disorders.

The U.S. Food and Drug Administration announced that it would be working closely with the drug’s manufacturers to help ensure an organized withdrawal of the medication. Patients currently taking Zinbryta are advised not to stop their medication without first speaking to their physician as their doctors will help determine alternate treatment options, if necessary.

Zinbryta remained on the market through April 30, 2018, during which time patients were allowed access to Zinbryta through a restricted distribution program. This is partly due to the drug’s severe complications and adverse side effects.

Overview: Multiple Sclerosis Drug

Zinbryta (daclizumab) was approved by the FDA on May 27, 2016. Zinbryta helps treat patients with multiple sclerosis.

Since Zinbryta’s market introduction, serious side effects and complications have been linked to the medication. A black-box warning was added to Zinbryta’s drug label advising patients of the risks for immune-mediated disorders and serious liver injuries associated with the medication. Physicians were advised to only prescribe Zinbryta if a patient has not responded well to another multiple sclerosis drug.

Other serious side effects have also been linked to Zinbryta. These include:

• Serious skin reactions, including erythema multiforme, that is the early from of Stevens Johnson Syndrome (SJS). If SJS is left untreated it may lead to even more adverse side effects and complications such as Toxic Epidermal Necrolysis (TEN); a skin disorder that mirrors severe skin burns and can be life-threatening.
• Liver injury and liver failure
• Encephalitis, including other severe immune reactions

Encephalitis is a very serious life-threatening condition pertaining to the inflammation of brain tissue. While it is most often caused by a viral infection, bacterial infection, or immune system disorder, it’s also been linked as a side effect of Zinbryta. While some signs of the condition are flu-like, other symptoms may include some of the following:

• Fatigue
• Fever
• Muscle pain or weakness
• Coordination problems
• Disorientation or mental confusion
• Nausea or vomiting
• Delirium or hallucination
• Irritability
• Light sensitivity
• Headache
• Stiff neck
• Seizures
• And more

According to the FDA, the agency is working closely with Biogen and Abbvie to conduct the market withdrawal. The FDA says that “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.” Since the drug’s approval, the FDA has been aware of the “complex safety profile of Zinbryta.”

The recall announced by Biogen and Abbvie was voluntary and not taken by and as a result of any FDA action. The agency does add, however, that “no new patients will start taking Zinbryta or participate in clinical studies.”