What is Zinbryta®?

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 Zinbrytafrom 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.

Zinbryta Side Effects

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:

  • Fever
  • Seizures
  • Changes in behavior
  • Confusion
  • Disorientation

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.

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Drug makers have a duty to provide safe products. If there are risks of harm associated with their products, they also must provide adequate warnings. If a drug maker fails to fulfill this duty, it could be held liable in lawsuits for injuries that may result.

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