Multiple sclerosis treatment Zinbryta was withdrawn in March and now a review by the European Medicines Agency has found its risks outweigh its benefits.
The review confirms the drug’s association with the risk of developing severe and potentially fatal immune reactions in the brain, liver and other organs. It was carried out by to the European Medicines Agency‘s (EMA)’s Pharmacovigilance Risk Assessment Committee (PRAC).
In March, when I reported that the drug had been withdrawn, I questioned the due diligence of the approval process.
EMA says that 12 cases of inflammatory brain disorders worldwide were potentially related to the medication’s use. Further, encephalitis and meningoencephalitis, or inflammation of the membranes enveloping the brain and spinal cord, resulted in three deaths.
Zinbryta is no longer available through European pharmacies and hospitals but the EMA recommends healthcare professionals to monitor patients who were treated with Zinbryta.
The EMA says: “Patients could be at risk from the start of treatment and for several months after stopping treatment, and it is not possible to predict which patients will be affected. The PRAC therefore confirmed its previous conclusions that risks of Zinbryta outweigh its benefits for patients with multiple sclerosis.”
Biogen and Abbie are working closely with the US Food and Drug Administration (FDA) for the withdrawal of Zinbryta in the US, according to Zinbryta’s website.
Anyone who takes Zinbryta is advised to contact their healthcare professionals and discuss a new treatment strategy.
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50shadesofsun.com is the personal website of Ian Franks, a freelance medical writer and editor for various health information sites. He enjoyed a successful career as a journalist, from reporter to editor in the print media. He gained a Journalist of the Year award in his native UK. Ian received a diagnosis of MS in 2002 and now lives in the south of Spain. He uses a wheelchair and advocates on mobility and accessibility issues.
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