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Europe Restricts Use of MS Therapy Zinbryta After Liver Damage Cases and a Death

July 12, 2017

The European Medicines Agency has temporarily restricted the use of Zinbryta (daclizumab) for relapsing multiple sclerosis (MS) after reports of patients experiencing severe liver damage and one dying of liver disease. In the meantime, the agency is taking a closer look at the Biogen drug’s safety profile, according to a press release. The U.S. Federal Drug Administration has yet to restrict Zinbryta’s use. Patients with liver damage are advised not to take Zinbyta under any circumstances. The same applies to those with another autoimmune disease in addition to MS.

The liver injuries occurred at different times in the treatment course, ranging from early in the treatment to several months after a patient stopped taking the medication. Researchers will review its safety, and when it’s finished, both patients and doctors will receive more information. Doctors should also check whether patients on Zinbryta should continue taking it or switch to another drug. They should also perform monthly liver checks on those who continue. Patients should learn to recognize the symptoms of liver injury and contact their doctor immediately if they experience any of these symptoms:

  • Unexplained nausea
  • Vomiting
  • Abdominal pain
  • Fatigue
  • Loss of appetite
  • Yellowing of the skin and eyes
  • Dark-colored urine

The medicine agency advises against stopping the medicine without first consulting a physician. Patients should also tell their physicians about other medications they are taking, including herbal medicines and supplements. Zinbryta’s impact on the liver can become worse when it is combined with certain compounds. The European Commission, which gives final approval to new drugs marketed in the European Union, requested the new review of Zinbryta. The FDA has yet to change its Zinbryta prescribing information or its recommendations on how it should be used.