Umesh Modi is a chartered accountant, and Pamini Jatheeskumar is a chartered certified accountant at Silver Levene...
  Don Lavoie is alcohol programme manager at Public Health England and Gul Root is lead...
Don Lavoie is alcohol programme manager at Public Health England and Gul Root is lead pharmacist, Health and Wellbeing Directorate, Public Health England
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A Resized Recall Image cb1March 6 2018

Zinbryta (daclizumab) is being withdrawn from the market following new concerns about the drug’s side effects. The drug, used by people with multiple sclerosis, is being withdrawn worldwide on a voluntary basis by its manufacturers. 

On Friday, the European Medicines Agency announced that it had started an urgent review of the drug following seven cases of serious inflammatory brain disorders in Germany, including encephalitis and meningoencephalitis, and one case in Spain.

In 2017, following a review of the medicine’s effects on the liver, the EMA had restricted the drug’s use to patients who had tried at least two other disease-modifying treatments and could not be treated with any other MS treatments.

Announcing the review into the effect on brain disorders, the EMA said: “The company that markets Zinbryta (Biogen Idec Ltd) has informed EMA of its intention to voluntarily withdraw the medicine’s marketing authorisations.” Zinbryta is also marketed elsewhere in the world by AbbVie.

Advice issued by the EMA includes:

  • doctors should not start new patients on Zinbryta;
  • doctors should review patients currently treated with Zinbryta and initiate alternative therapy, as soon as possible;
  • patients must not stop their medication without discussing with their doctor;
  • patients who have any questions should talk to their doctor.

The EMA will be contacting EU doctors directly with the information. As Biogen has also informed the EMA of its decision to stop ongoing clinical studies with Zinbryta in the EU, “patients in clinical studies who have any question should contact the doctor treating them in their study.”

Over 8,000 patients worldwide have been treated with Zinbryta. In the EU, the majority of patients are in Germany.

Link:
EMA announcement    

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