The Legal Examiner Mark The Legal Examiner Mark The Legal Examiner Mark search twitter facebook feed linkedin instagram google-plus avvo phone envelope checkmark mail-reply spinner error close
Skip to main content

On March 2, 2018, pharmaceutical companies Biogen and AbbVie announced the worldwide withdrawal of the drug Zinbryta (daclizumab), which is used to help treat multiple sclerosis (MS).

In a related press release, the companies stated that the recall was “in the best interest of patients,” and was based on patient reports of inflammatory encephalitis and meningoencephalitis—both forms of brain inflammation.

“Given the nature and complexity of adverse events being reported,” the companies stated in their press release, “characterizing the evolving benefit/risk profile of Zinbryta will not be possible going forward given the limited number of patients being treated.”

About a month earlier, the European Medicines Agency (EMA) announced it had started an urgent review of the medication following seven cases of serious inflammatory brain disorders in Germany and one case in Spain.

EMA Announces Recall of Zinbryta Due to Immune Reactions

Only a week after the EMA announced its urgent review, European regulators recommended an immediate recall and suspension of the product. This, after receiving a total of 12 reports of serious inflammatory brain disorders worldwide, three of which were fatal. In the EMA’s preliminary review of the evidence, it was noted and reported that the agency was seeing immune reactions to the drug, including severe immune reactions affecting several other organs.

To protect patients’ health, the EMA recommended that no new patients start treatment with Zinbryta. It advised healthcare professionals to immediately contact patients currently being treated with the drug and have them stop that treatment and use something else instead.

Patients were further advised to watch for symptoms of possible side effects, including:

  • persistent high temperature
  • severe headache
  • nausea
  • tiredness
  • yellowing of the skin
  • eyes and vomiting

These could all be signs of a reaction to Zinbryta. The EMA also recommended doctors follow-up with blood tests for six months after stopping treatment to check for side effects.

The FDA is currently working with Biogen and AbbVie to help ensure a well-organized withdrawal of the drug is carried out throughout the United States. It’s also helping to make sure doctors have the information they need to move their patients over to another medication. The FDA told patients using Zinbryta that they should not stop their medication without first talking with their doctor and should contact their doctor immediately if they have any new and unexplained symptoms.

FDA Approves Zinbryta with Boxed Warning

The FDA first approved Zinbryta in May 2016 for the treatment of patients with relapsing forms of MS. The administration warned even then that the drug should be used only in patients in which other forms of treatment didn’t work. Zinbryta was administered as a subcutaneous injection once a month.

The FDA based its approval on two clinical trials that showed the drug to be effective at helping to prevent clinical relapses. The manufacturers were required to include a boxed warning on the label alerting patients and doctors to the potential for severe liver injury, and the medication was available only through a limited distribution program.

Comments are closed.

Of Interest