For some Multiple Sclerosis (MS) patients whose symptoms failed to respond to traditional medications, Zinbryta® (daclizumab), offered a glimmer of hope. After less than two years on the U.S. market, however, concerns have been raised that the drug’s risks greatly outweighed any benefit.
Medical drug manufacturers Biogen Inc., and AbbVie Inc., voluntarily withdrew Zinbryta from the global market in March 2018, urging doctors to stop prescribing the drug and transition current patients to another, presumably safer, treatment. Read their announcement.
In a statement, the FDA reported it was reviewing multiple claims of serious inflammatory brain disorders and other effects associated with the Zinbryta. Complications from the drug can be debilitating, and sometimes fatal.
If you or a loved one suffers from MS and developed a worsening, inflammatory brain disorder, such as encephalitis or meningoencephalitis, after taking Zinbryta, you may contact medical attorney Carmen Scott by email or call 1.800.768.4026 for more information and to discuss your potential claim.
If you believe that you may have a claim, consider contacting an attorney as soon as possible. A statute of limitations (SOL) may limit the time you have to file a claim. If you do not file your claim within the SOL, you may lose it forever.
Zinbryta Withdrawal Background
When the FDA approved Zinbryta in May 2016, it did so under the caveat that the drug only be prescribed to patients who did not respond to two or more MS medications. “Zinbryta has serious safety risks,” the agency stated, giving the drug a boxed warning that stipulated it would only be made available “through a restricted distribution program under a Risk Evaluation and Mitigation Strategy.”
Zinbryta’s label warned of severe, potentially life-threatening, liver injuries, immune conditions, inflammation of the colon, skin reactions, and enlarged lymph nodes as possible complications of the drug. During clinical trials, patients also complained of additional cold and influenza-like symptoms, including upper respiratory tract infections, rash, dermatitis, throat pain and other issues.
The European Medicines Agency, however, announced a recall of the drug after recording 12 reports of severe inflammatory brain disorders that developed after Zinbryta use, including at least three fatal cases.
Symptoms of brain inflammation can include:
- Changes in behavior
The FDA cited “concern about the drug’s evolving benefit/risk profile” while announcing Zinbryta’s withdrawal in the U.S. and around the world.
Motley Rice medical attorneys have extensive experience litigating for patients who have suffered severe adverse effects and complications caused by dangerous prescription and over-the-counter drugs. We understand that as a patient or family member, your familiarity with medications you have been prescribed, and knowledge of potential risks, may be limited. Our attorneys have the resources needed to thoroughly investigate and identify potentially harmful products, medical causation, compliance with FDA regulations, alleged inadequacy of warnings, alleged wrongdoing and other factors that could affect your potential claim.
In addition to reviewing potential Zinbryta cases, our attorneys hold leadership positions and have represented clients in several medical drug cases, including Motley Rice co-founder Joe Rice serving on the Plaintiffs’ Steering Committee in the Lipitor® multidistrict litigation consolidated in South Carolina. Additional medical drugs under review by our attorneys include diabetes drugs Januvia®, Victoza®, Janumet®, and Byetta®; Taxotere®; and Zofran®.
Consult a medical professional before stopping or changing any medication.