When Zinbryta (Daclizumab) was approved by the U.S. Food and Drug Administration (FDA) in 2016, it was expected to reduce the rate of relapses in multiple sclerosis (MS) patients and become one of the key treatment options for the chronic and debilitating central nervous system disease. In early 2018, the once-promising drug was found to have life-threatening side effects including encephalitis and meningoencephalitis, two serious brain inflammation conditions, as a global market withdrawal was issued.
What is Multiple Sclerosis
In multiple sclerosis, the body’s immune system begins to attack the central nervous system, which includes the brain and spinal cord. Over time the myelin sheath surrounding the nerves becomes damaged, and the nerves are unable to function correctly. Symptoms of MS may include blurred vision, balance and coordination issues, tremors, slurred speech, memory issues, paralysis and more. It is estimated more than 2.3-million people worldwide have MS.
Zinbryta was developed to treat relapsing forms of multiple sclerosis by inhibiting the inflammation response of the body’s T cells and increasing immune cells to help stop the nerve damage.
Early Problems with Zinbryta
Prior to approval, the FDA required a black box warning and a medication guide be distributed with every prescription of Zinbryta.
In November of 2017, the European Medicines Agency (EMA) began restricting its use due to serious liver damage. Only patients who had tried two other disease-modifying treatments and could not be treated with any other multiple sclerosis treatments were allowed to take the medication.
EMA issues recall, Zinbryta Global Market removal begins
In January 2018, the EMA issued an immediate suspension and recall of Zinbryta after receiving at least 12 reports of inflammation of the brain cases in Germany and Spain which included three fatalities all possibly linked to the drug. These issues or encephalitis were in addition to Zinbryta patients reporting severe immune reactions and damage to the liver and several organs.
According to the FDA website, the agency is aware of the encephalitis reports and is conducting a review of similar events.
According to the FDA, “on March 2, 2018, Biogen and Abbvie announced a voluntary withdrawal of Zinbryta (daclizumab), a multiple sclerosis (MS) drug, from the global market, noting concern about the drug’s evolving benefit/risk profile. As a result, FDA is working closely with the manufacturers to help ensure a well-organized withdrawal from the market in the United States, and to ensure that health care professionals have the information they need to carefully transition their patients using Zinbryta to another treatment.” More information on the drug withdrawal can be found on the FDA site.
How Meyers & Flowers can help
It is estimated more than 8,000 MS patients have taken the self-administered drug in the last two years. If you or a member of your family has suffered severe health complications due to taking Zinbryta, the attorneys at Meyers & Flowers can help.
Our firm has an extensive history of helping those injured by pharmaceutical companies due to dangerous and, at times, deadly drugs. Contact us directly at 877-221-2511 or fill in our free online case evaluation form.
- Reuters: Biogen, AbbVie withdraw multiple sclerosis drug Zinbrtya
- Reuters: Europe's medicines regulator calls for recall of Biogen, AbbVie multiple sclerosis drug
- FDA: FDA working with manufacturers to withdraw Zinbryta from the marketing in the United States
- EMA: Multiple sclerosis medicine Zinbryta suspened in the EU