Tennessee Zinbryta Lawyer
Multiple sclerosis (MS) is an unpredictable disease of the central nervous system that affects more than 2.3 million people worldwide. MS affects each victim differently. But the more common symptoms include numbness and tingling–and in severe cases, blindness and paralysis. Although there are a number of drugs approved to manage the symptoms of MS, there is presently no known cure.
In 2016, the U.S. Food and Drug Administration (FDA) approved daclizumab, a drug marketed under the brand name Zinbryta, as an “immune-modulating therapy” for patients with relapsing MS. But on March 2, 2018, the FDA and Zinbryta’s manufacturers, Biogen and AbbVie, announced the drug’s withdrawal from the market. This action came shortly after Europe’s top drug regulator ordered an “immediate suspension and recall” of Zinbryta. According to the European Medicines Agency (EMA), Zinbryta is linked to “12 reports of serious inflammatory brain disorders worldwide,” including 3 fatalities.
If you or a loved one have MS and experienced adverse effects after taking Zinbryta, you may have a legal claim against Biogen and AbbVie. The experienced Tennessee Zinbryta lawyers at Fox & Farley can review your case and help you decide whether to seek compensation for your injuries.
FDA, EMA Order Drug’s Withdrawal Due to Potential Brain Inflammation
The FDA was well aware of Zinbryta’s risks when it granted initial approval in 2016. But in recognition of the drug’s “complex safety profile,” Zinbryta’s label warned doctors and patients of the potential for live injury and “other-immune mediated disorders.” The FDA advised Zinbryta should only be prescribed to “patients who have had an inadequate response to two or more multiple sclerosis drugs.” The European Medicines Agency identified two potentially catastrophic side effects from the use of Zinbryta: encephalitis, the inflammation of the brain; and meningoencephalitis, which affects both the brain and the spinal cord.
Biogen and AbbVie stopped distributing Zinbryta altogether as of April 30, 2018. But the FDA instructed patients not to stop taking the drug without their doctor’s approval. The agency further advised doctors to continue monitoring Zinbryta patients’ liver function “for up to six months after the last dose.”
Learn More About Your Legal Rights from a Tennessee Dangerous & Defective Drug Attorney
Altogether, the EMA estimated about 8,000 MS patients globally received Zinbryta during its life cycle. If you are a family member are one of them, you need to be on the lookout for possible symptoms of brain inflammation, including confusion, disorientation, fever, and seizures. Obviously, you should always speak to your treating physician if you suspect there is anything wrong with your medication.
But you should also contact a qualified Tennessee Zinbryta lawyer to explore your potential legal options. Drug manufacturers like AbbVie and Biogen are required to comply with state consumer product safety laws in addition to FDA regulations. In other words, anyone who sells or distributes a defective or dangerous drug can be held liable for monetary damages to the injured patients. To learn more about your legal rights, contact Fox & Farley, Attorneys at Law, in Clinton, Knoxville, Sevierville, and Nashville today.