Zinbryta is being voluntarily recalled across the globe by its manufacturers per the suggestion of European Medicines Agency and in conjunction with the Food & Drug Administration.
What is Zinbryta?
In May 2016, the Food and Drug Administration approved Zinbryta (daclizumab) to treat those with relapsing forms of multiple sclerosis (MS). It has only been used by about 8,000 patients diagnosed with MS because of its link to serious health complications.
Multiple sclerosis is a disease that attacks the central nervous system by causing the body’s immune system to wrongly attack, and thus damage, the protective sheath around nerve cells. The result is debilitating for those diagnosed. According to the National MS Society website, there is no known cause of MS but theorists posit environmental factors in those genetically predisposed to respond could be a contributor.
Zinbryta works by reducing the activity of cells that attack the immune system. The active ingredient, daclizumab, binds itself to immune cells to reduce this occurrence.
Zinbryta side effects
With such a short time on the market, Zinbryta has already earned a “black-box warning” from the FDA. The risk of inflammatory brain disorders, hepatic injury including liver failure and serious skin reactions like Stevens-Johnson Syndrome are what has prompted the worldwide recall of the drug.
Our lawyers are pursuing Zinbryta lawsuits for the following injuries / complications:
- Liver injury or liver failure
- Drug induced Hepatitis
- Inflammatory encephalitis
- stevens johnson syndrome (SJS) / erythema multiforme major
- Other immune-medicated disorders
- Wrongful Death
Zinbryta causes global concern
Three deaths in the United States have been reported in patients who were prescribed Zinbryta, which prompted the Food and Drug Administration to launch an investigation to reassess the drugs profile.
A Risk Evaluation and Mitigation Strategy was implemented due to the increase in significant side effects. Typically used as a last resort, Zinbryta was prescribed to patients who had previously unsuccessful responses to two or more MS drugs.
Approximately 8,000 people worldwide have taken Zinbryta. Notably, reports of serious brain inflammation in at least 12 people, 3 of which resulted in death, made it a concern among physicians to prescribe Zinbryta to patients.
Zinbryta to be withdrawn from the global market
Zinbryta’s manufacturers, Biogen and AbbVie, issued a statement explaining that since such a small amount of patients have taken the drug, it makes it difficult to monitor the adverse events linked to it.
However, AbbVie and Biogen issued a voluntary global withdrawal of Zinbryta from the biochemical market on March 2, 2018. In response, the Food and Drug Administration issued a statement addressing the commitment to a well-organized withdrawal from the US market:
The European Medicines Agency (EMA) recommended doctors immediately cease any forms of Zinbryta treatment and to prescribe alternative medicines to their patients. However, the drug will be available to physicians until April 30, 2018 for patients and healthcare professionals on an as-needed basis. Physicians were also recommended to conduct follow ups with their patients for at least six months to monitor any signs of brain inflammation or liver damage.
Patients currently taking Zinbryta are encouraged to speak with their healthcare provider before discontinuing use of the drug. They should contact their doctor immediately if they have new and unusual symptoms.
Do You Have a Zinbryta Lawsuit? Contact Our Lawyers
If you or a loved one has suffered from a brain infection, liver injury or skin disorder after taking Zunbryta, you are not alone. To learn how the lawyers at Johnson // Becker can help you and your family, please contact us for a Free Case Evaluation. We would be honored to speak with you and will respond promptly to every Zinbryta lawsuit inquiry we receive.