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Zinbryta (daclizumab beta) is a multiple sclerosis (MS) medicine used in relapsing forms of this disease. Although this drug was on the market for less than two years between 2016 and 2018, European and US regulatory agencies now found it could be associated with inflammatory brain disease.
Patients who suffered from these injuries after taking it are now starting to file a Zinbryta lawsuit, claiming the drug’s manufacturers have been negligent in warning the public about its dangers. If you are among the unfortunate ones who suffered a serious injury after using daclizumab for MS, contact us now. We will put you in contact with a skilled team of attorneys who will advise you and evaluate the eligibility of your case for free.
Daclizumab is a humanized monoclonal antibody used for the therapy of adult patients with relapsing forms of MS. Zinbryta is manufactured by AbbVie and Biogen Inc., and was released to the U.S. market in 2016.
Multiple sclerosis is a lifelong autoimmune disease in which the body’s immune system destroys myelin, a substance that covers and protects nerves. Once this happens, the connections between the body and the brain got disrupted and the patient suffers from a broad range of serious symptoms ranging from loss of balance to sensorial problems, loss of sight, and pain. While the exact mechanism through which Zinbryta reduces MS symptoms is unknown, the net effect is a reduction of the abnormal immune cell response.
When it originally hit the market, Zinbryta came with the strongest label warning issued by the U.S. Food and Drug Administration (FDA): the black box. Within this label, the U.S. regulator warned prescribers about a serious danger of liver injury which can sometimes be fatal. In clinical trials, one subject died due to autoimmune hepatitis, which could occur even later on, up to four months after administration. Because of that, Zinbryta is contraindicated in patients who already suffer from hepatic disease, and is generally stopped when blood transaminases (ALT and AST) and bilirubin levels are too high.
Zinbryta is also associated with severe immune-mediated disorders including lymphadenopathy, non-infectious colitis, and dermatologic reactions in approximately 5% of patients. Once again, whenever a patient develops one of these side reactions, the clinician might consider stopping Zinbryta.
Due to these serious dangers, patients could be prescribed with Zinbryta only after a thorough risk/benefit assessment was performed through the Risk Evaluation Mitigation Strategy (REMS) program. In fact, each individual patient would require approval from the FDA before Zinbryta could be used, and some specific requirements had to be met. In particular, the MS drug could be recommended only in subjects who did not respond to treatment with two or more other multiple sclerosis medications.
According to the medication’s label, Zinbryta’s most common side effects are:
Inflammatory brain disease, including encephalitis, meningoencephalitis, and possible death
In March 2018, AbbVie and Biogen issued a worldwide voluntary Zinbryta recall, explaining they were uncertain about an alleged risk of brain inflammation reported by some patients.
The FDA is currently reviewing all the adverse reaction reports of patients who took Zinbryta after 3 cases of encephalitis or meningoencephalitis have been reported. This type of brain inflammation disorder might cause seizures, confusion, and in the most severe instances can prove to be fatal.
The European regulatory agency, the European Medicines Agency (EMA), has confirmed that Zinbryta poses a risk of potentially lethal immune reactions affecting the brain and liver, even several months after the treatment has been stopped. Therefore, a Zynbrita withdrawal has been issued since its potential risks outweigh its serious health risks.
Now, in the United States, patients who took the drug and suffered an injury will start filing Zinbryta lawsuits, seeking monetary compensation for their damage. As of January 2021, it’s still too early to ascertain the exact number of litigations that will ensue, and whether they will centralize them in a Multidistrict Litigation (MDL) anywhere soon.
If you suffer from multiple sclerosis, you’re already facing the tremendous burden of living with severe disease. As a medical consumer and patient, you must be able to trust the pharmaceutical companies that manufacture and market the drugs you need to treat your condition. It is your right to be treated with only the best, most well-researched drugs, knowing they will help you feel better and get healthier to the best of your possibilities.
Even a new product is dangerous in any way, a manufacturer is bound by law to inform you of all the potential consequences of taking a certain medication. If the pharmaceutical company omits to explain to you what the potential dangers of a drug are, you’re stripped of your chances of making an informed decision.
If you have sustained any Zinbryta injury, there’s a chance that the manufacturer has been negligent in warning you about its potential adverse reactions. If that’s the case, you might be eligible for financial compensation by filing a lawsuit. If you want to file a Zinbryta lawsuit, call us today. We will find the best attorneys available to make sure your case is successful in court and reward you with just compensation for your pain and suffering.