According to a story from wivb.com, a treatment for multiple sclerosis was recently recalled and taken off the shelves after some disturbing reports of side effects. The drug in question is called daclizumab, a therapy manufactured by Biogen and Abbvie. The treatment was marketed under the brand name Zinbryta. All ongoing clinical studies that were using the drug have also been halted.
The drug was pulled from the shelves on the day that the European Medicines Agency (EMA) issued a statement ordering an ‘urgent review’ of the treatment. The statement came after a total of eight reports came in citing cases of encephalitis or meningoencephalitis, which are conditions in which the brain is inflamed. Brain inflammation, which is normally caused by some form of infection, is a serious medical condition that could never be considered an acceptable drug side effect. Brain inflammation requires timely and extensive treatment with antibiotics that are capable of crossing the blood-brain barrier.
Daclizumab is approved for the treatment of multiple sclerosis in much of North America and Europe, and it is estimated that more than 8,000 people have received the drug. The drug has been somewhat controversial since its original approval by the FDA in May of 2016. Daclizumab was specifically meant for treating the relapsing-remitting variant of multiple sclerosis, and the FDA issued approval with two major warnings, citing an increased risk of severe liver damage and/or immune system complications. The treatment works as an immune system modulator. Before taking the drug, multiple sclerosis patients were expected to have tried a minimum of two other therapies for their disease and could not be using any additional multiple sclerosis treatments while using it.
All of these restrictions add up to a treatment that is probably only suitable as a last resort. Daclizumab was only available by a restricted distribution system that required consistent monitoring of patients. Judging by the warning issued by the FDA upon approval, brain inflammation was not a side effect that was successfully detected in clinical trials, and only appeared once the drug was being used on a scale far greater than a trial. Otherwise, daclizumab would not have obtained approval for public use.
