MS drug withdrawn following brain disorders


recall regulatory

Biogen Australia is withdrawing Zinbryta (daclizumab) from the global and Australian market following cases of serious inflammatory brain disorders

The TGA says it has not received any reports of inflammatory brain disorders occurring in Australian patients who have been prescribed Zinbryta.

The cases of immune-mediated encephalitis and meningoencephalitis reported occurred in Europe.

Biogen says it will be coordinating a worldwide withdrawal of Zinbryta. To give time for Australian patients to transition off the medicine it will be supplied in Australia until 31 May 2018.

Biogen Australia says it has written to health professionals who treat patients with Zinbryta explaining the situation and advising on the next steps.

It informed consumers that they should be contacted by their treating health professional to discuss alternative treatment options, but if they have not yet been contacted they should contact them as soon as possible.

Consumers are advised to be aware that adverse drug reactions to Zinbryta could potentially occur up to six months after discontinuation.

They should contact a health professional immediately if any new symptoms such as prolonged fever, serious headache, nausea or vomiting occur.

Biogen has recommended that no new patients should be started on the drug in the leadup to its withdrawal.

The US’ Food and Drug Administration says that the complex safety profile of Zinbryta has been recognised since the time of approval in that country.

It said it has continuously monitored adverse events associated with use of Zinbryta and has updated product labelling as new information became available.

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