If you have multiple sclerosis and suffered from Zinbryta brain inflammation you could be eligible to participate in this lawsuit investigation.

Drug manufacturers Biogen and AbbVie voluntarily withdrew Zinbryta from the market in April 2018 because of patient reports of swelling in the brain after using the drug. In a letter regarding the recall sent to health care providers in March, the drug makers referred directly to Zinbryta brain inflammation.

“Cases of encephalitis and meningoencephalitis have been reported in patients treated with Zinbryta,” noted the letter.

Encephalitis is swelling in the brain tissue itself, and meningoencephalitis is inflammation of the membranes that cover the brain. The majority of encephalitis incidents are caused by either a bacterial or viral infection.

A minimum of 12 cases of swelling of the brain have been linked to Zinbryta around the world. In three of those cases Zinbryta brain inflammation proved fatal.

Zinbryta Brain Inflammation Reported Among Serious Reactions

The FDA approved Zinbryta (daclizumab) in May 2016. The drug was prescribed to treat patients with multiple sclerosis who had not responded well to two or more other MS drugs.

Multiple sclerosis (MS) causes the patient’s immune system to attack the protective sheath surrounding nerve cells in the brain and spinal cord, together known as the central nervous system. MS is a chronic, inflammatory, autoimmune disease that causes communication failure between the brain and other parts of the body.

Zinbryta worked to stop immune system from damaging the central nervous system by binding to immune cells and fighting off the cells trying to attack the protective sheath.

The FDA admitted Zinbryta had a “complex safety profile” since its approval.

Not long after entering the pharmaceutical market, the FDA issued a black box warning because of the risk of serious liver injury, enlargement of lymph nodes, inflammation of the colon and other immune-mediated problems. Some patients also reported serious skin reactions, such as erythema multiforme, an early form of Stevens Johnson Syndrome, which is a potentially lethal reaction involving the skin and membranes that look and feel like severe burns.

Because of these risks, the FDA asked for Zinbryta to be reserved as a choice only for patients who hadn’t responded adequately to two or more MS drugs.

The FDA placed the drug in a program known as Risk Evaluation and Mitigation Strategy (REMS). The REMS program requires certain medications with serious safety concerns to be closely watched and distributed with very specific instructions of use. The REMS program ensures medications with serious risks only is available to patients when the benefits outweigh the risks.

When a dozen patients suffered Zinbryta brain inflammation and three of them died, Biogen and AbbVie voluntarily withdrew Zinbryta from the market.

The FDA worked with the drug companies “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.”

If you took Zinbryta and developed swelling in the brain, you could be eligible to participate in this lawsuit investigation.