It was announced recently that multiple sclerosis drug, Zinbryta, will be taken off the market after serious side effects were reported in Europe including inflammation of the brain.
Zinbryta, generically known as daclizumab, was approved by the FDA just a couple years ago in 2016. It was approved to treat relapsing forms of multiple sclerosis. Those multiple sclerosis patients who have not responded well to two or more other multiple sclerosis drugs may be prescribed Zinbryta.
However, Zinbryta was recently pulled off the global market by drug makers Biogen and Abbvie in March 2018 because of growing reports of inflammation of the brain and other alarming side effect conditions.
Beginning March 2, 2018 and continuing through the month of April, Biogen and Abbvie say that the voluntary recall will be complete by April 30, 2018.
According to the Zinbryta website, “Biogen and AbbVie believe it is in the best interest of patients to voluntarily withdraw Zinbryta in the United States. Given the nature and complexity of adverse events being reported with Zinbryta, characterizing the evolving benefit/risk profile of Zinbryta will not be possible going forward, given the limited number of patients being treated.”
They went on to suggest that patients should speak with their doctors about their next steps for treatment if they have been taking Zinbryta.
The European Medicines Agency announced an “urgent review” of the multiple sclerosis drug, even though a small amount of people currently take Zimbryta. The serious conditions that were reported included disorders affecting the inflammation of the brain like encephalitis and meningoencephalitis.
In fact, at least a dozen cases of encephalitis have been reported in connection with taking Zimbryta. Of these, three have resulted in death.
In addition to disorders affecting inflammation of the brain, Zinbryta has also been associated with deadly skin reactions such as Stevens Johnson syndrome as well as liver failure.
Surprisingly, even though Zinbryta has only been on the market for a short period of time, the serious side effects have led to a black box warning on the drug regarding liver injury and other disorders. Also, the warning suggests that the drug should only be given to those who have not responded well to other multiple sclerosis drugs.
The drug, before it was voluntarily recalled, was only available to patients through a restricted distribution program.
The Wall Street Journal, however, breaks down the communication between the drug companies and the patients and doctors. They quote different industry executives who have various opinions about how the voluntary recall was handled. Some industry experts think that the drug makers of Zinbryta were helpful and communicative to patients and doctors. Others believe that the use of industry jargon makes their communication difficult to access for the lay person.
Either way, those who are concerned about this drug believe that not enough warning was given to patients about inflammation of the brain. Possible symptoms of inflammation of the brain caused by Zinbryta include fatigue, muscle pain and weakness, fever, problems with coordination, disorientation, mental confusion, nausea, vomiting, headache, light sensitivity, hallucination or stiff neck.
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If you or a loved one were diagnosed with encephalitis, liver injury, Stevens Johnson Syndrome (SJS), Toxic Epidermal Necrolysis (TEN), or another complication after taking Zinbryta, you may have a legal claim. Filing a Zinbryta lawsuit or joining this Zinbryta class action lawsuit investigation could help you recover compensation for medical bills, pain and suffering, and more.
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