MS medication withdrawn over safety concerns
Zinbryta, an injectable medication used to treat relapsing multiple sclerosis, will no longer be available following its withdrawal from the market on March 2, 2018.
The drug was pulled following the reports of encephalitis in eight people in Germany and Spain. No further details about these eight cases are currently available.
It should be noted that encephalitis cases among people taking Zinbryta were rare. The connection between Zinbryta and encephalitis is unclear, and no definitive cause-and-effect has been established. However, when suspicious events occur, regulators can launch an investigation into a drug’s safety. Such an investigation was announced on March 2 by the European Medicines Agency.
According to Biogen and AbbVie, the companies involved in the manufacturing and marketing of Zinbryta, a full safety appraisal can’t be done because so few people are taking Zinbryta. This is because very large databases are needed to detect rare side effects. So the companies decided that a safer option was to withdraw the drug entirely.
For people taking Zinbryta, this means that the drug will stop being available. So contact your neurologist or MS clinic as soon as possible to talk about your other treatment options. Some safety monitoring may be required after you stop taking Zinbryta.
It may also be advisable to contact one of the support coordinators from the Biogen Above MS program (www.abovems.com) for further information and advice.
Encephalitis is a swelling of the brain that can be the result of an infection, autoimmune reactions or other cause. Symptoms of encephalitis can include fever, headache, confused thinking, seizures, or problems with senses or movement. Encephalitis can be life-threatening and anyone with symptoms is urged to go to the Emergency Department immediately.
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