Drug companies Biogen and Abbvie have recently announced a voluntary Zinbryta withdrawal on March 2, 2018, after receiving injury reports from patients indicating serious brain inflammation disorders and serious allergic reactions.

The voluntary Zinbryta withdrawal was conducted after the manufacturers had received reports of brain inflammation, with at least 12 cases of encephalitis reported worldwide that included three fatalities.

The voluntary Zinbryta withdrawal had recalled the multiple sclerosis (MS) medication from the global market, with the FDA working with Biogen and Abbvie through the recall process.

The FDA states that working with the drug companies will “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.”

The voluntary Zinbryta withdrawal was conducted after an investigation by the European Medicines Agency (EMA), which discovered the 12 cases of brain inflammation worldwide including cases of encephalitis and meningoencephalitis and the three fatalities.

Biogen and Abbvie have been very cooperative with the FDA and were the first to initiate the voluntary recall without any prompting from the FDA. The FDA has stated that Zinbryta will no longer be prescribed to patients, nor will the drug will be used in clinical trials.

The FDA is currently reviewing other potential cases of Zinbryta encephalitis, and whether or not the reaction was caused by the drug, multiple sclerosis, or another unknown factor.

Overview of Zinbryta Complications

The FDA approved Zinbryta (daclizumab) on May 27, 2016, to be a treatment drug for patients suffering from relapsing forms of multiple sclerosis. Zinbryta is typically prescribed to patients who have not reacted well to other treatment medications, with the drug being available for prescriptions until April 30, 2018, which was shortly before the voluntary Zinbryta withdrawal was announced.

Multiple sclerosis is an autoimmune disease, which causes the immune system to attack the body and greatly damage the protective layers surrounding nerve cells in the central nervous system. This means the brain and spinal cord are greatly impacted, causing severe movement difficulties.

This makes medications like Zinbryta vital for MS patients, which improve quality of life and possibly increase the patient’s longevity. However, Zinbryta was not on the market long before reports of encephalitis were submitted, with the FDA stating it had been previously aware that the drug’s safety profile was complex and that patients could suffer adverse drug reactions.

These serious Zinbryta complications had previously earned the drug a black box warning of serious liver injury and other immune-related disorders, with the FDA restricting the drug’s distribution channels. The serious side effects associated with Zinbryta include, but are not limited to:

• Encephalitis or Brain Inflammation
• Liver Failure or Serious Liver Damage
• Serious Skin Reactions including Stevens-Johnson Syndrome (SJS) and Toxic Epidermal Necrolysis (TEN)

Even though Biogen and Abbvie conducted a voluntary Zinbryta withdrawal, the companies still may have failed to adequately warn patients and physicians against potential encephalitis or other serious drug reactions.

Patients who developed Zinbryta complications may be able to file legal action for their injuries, to seek potential medical compensation.