A class action investigation has been launched against Biogen and AbbVie, for allegedly failing to warn patients against potentially fatal Zinbryta complications like brain inflammation.

Due to brain inflammation disorders like encephalitis and meningoencephalitis, the pharmaceutical companies are voluntarily withdrawing Zinbryta from the international market. This market withdrawal was announced on March 2, 2018, which has spurred major concern about brain inflammation in the medical community and patient population.

There have been at least 12 cases of Zinbryta encephalitis reported around the world, with three of the cases being fatal. The recall is expected to completed by April 30, 2018.

The Zinbryta website states: “Biogen and AbbVie believe it is in the best interest of patients to voluntarily withdraw Zinbryta in the United States. Given the nature and complexity of adverse events being reported with Zinbryta, characterizing the evolving benefit/risk profile of Zinbryta will not be possible going forward, given the limited number of patients being treated.”

Encephalitis is a brain inflammation condition, which is most commonly caused by viral infections and bacteria or fungi in rare cases. The two main types of encephalitis are primary and secondary, with the form occurring from a viral affliction to the brain and spinal cord.

Secondary encephalitis occurs when the infection spreads to other parts of the body, eventually causing brain inflammation. Encephalitis typically induces high fever and vomiting, and this condition can be potentially fatal in rare cases.

Zinbryta patients should talk to their doctors about potential brain inflammation, along with the other possible serious Zinbryta complications.

Overview of Zinbryta Brain Inflammation

Zinbryta (daclizumab) was approved by the FDA on May 27, 2016, to be a treatment drug for adult patients suffering from relapsing multiple sclerosis (MS). Zinbryta is typically prescribed when one or two multiple sclerosis drugs have failed, and works by binding immune cells and reducing the activity levels of the cells attacking the immune system.

Multiple sclerosis is an autoimmune disorder in which the immune system attacks the body. More specifically, the immune system targets the protective sheath around nerve fibers and causes complication breakdowns between the brain and the rest of the body. If left untreated, patients can be completely immobile and left with permanent nerve damage.

While there is no cure for multiple sclerosis, patients rely on drugs like Zinbryta to make the disease more manageable. Around the same time as the market withdrawal announcement, the European Medicines Agency announced there was an “urgent review” being conducted after receiving reports of brain inflammation that caused encephalitis and meningoencephalitis.

Zinbryta has also been linked to other serious side effects like liver failure, and allergic skin reactions like Stevens Johnson Syndrome. There is already a black box warning included on the Zinbryta waning label regarding liver injuries and related complications.

As of now, Zinbryta’s distribution has been greatly reduced and can only be accessed through a certain distribution program. Even with this limitation in place, current Zinbryta patients are still at risk for brain inflammation.