Free Confidential Lawsuit Evaluation: If you or a loved one was injured after being prescribed Zinbryta, you should contact our law firm immediately. You may be entitled to monetary compensation by filing a suit against the drug's manufacturers and our lawyers can help.
What is Zinbryta?
Developed in a joint partnership between Biogen and Abbvie, Inc., Zinbryta (generic: daclizumab) is a humanized monoclonal antibody drug used to treat adults with relapsing forms of multiple sclerosis (MS). The medicine works by binding to immune cells (lymphocytes or white blood cells) and reducing the activity of cells involved in the immune attack that cause damage associated with MS.
How Does it Work?
Your immune system makes cells, called T-cells, that kill viruses and bacteria. But in MS these cells are believed to attack the myelin coating around nerves in your brain and spinal cord.
Daclizumab stops T-cells from getting into your brain and spinal cord and causing damage to the nerves there. This protects the nerves from inflammation. The MS drug also rebalances the body's immune system.
Adult patients inject daclizumab under their skin once every 4 weeks.
U.S. Food and Drug Administration Black Box Warning on Zinbryta
When it first hit the market, the labeling of Zinbryta carried a black box warning which described a serious danger of liver injury which can sometimes be fatal. In clinical trials, one subject died due to autoimmune hepatitis, which could occur up to 4 months after administration. This is why Zinbryta is contraindicated in patients who already suffer from hepatic disease, and is typically discontinued when blood transaminases (ALT and AST) and bilirubin levels are too high.
Zinbryta has also been linked to severe disorders including lymphadenopathy, non-infectious colitis, and dermatologic reactions in certain patients. Whenever a patient develops one of these side reactions, the prescribing doctor should consider stopping Zinbryta.
As a result of these potential severe risks, patients could be prescribed Zinbryta only after a thorough risk/benefit assessment was performed. In fact, each individual patient would require approval from the Food and Drug Administration before Zinbryta could be prescribed, and some specific requirements had to be met. Specifically, the MS drug could be recommended only in patients who did not respond to treatment with 2 or more other relapsing multiple sclerosis medications.
Was There a Warning About Encephalitis?
The severity of Zinbryta side effects have led to a Risk Evaluation and Mitigation Strategy (REMS) which makes the drug only available through a restricted distribution program. Neither Biogen nor Abbvie warned consumers or physicians about the risk of encephalitis or Stevens Johnson Syndrome (SJS) from Zinbryta.
Multiple Sclerosis Drug Side Effects
Serious side effects of Zinbryta include:
- Liver failure
- Drug-induced hepatitis
- Potentially life-threatening inflammatory brain disease
- Inflammatory encephalitis
These patient safety risks have been reported to occur at any time during treatment with Zinbryta, including up to 4 months after discontinuing the drug.
European Medicines Agency Moves to Recall Zinbryta
In March 2018, AbbVie and Biogen issued a worldwide recall of Zinbryta after numerous patients reported developing severe brain inflammation.
The FDA is currently reviewing all the adverse events associated with Zinbryta after 3 cases of encephalitis or meningoencephalitis were reported. This type of brain inflammation causes seizures, confusion, and even death.
The EMA has confirmed that Zinbryta immune modulating therapy poses a risk of potentially lethal immune reactions affecting the brain and liver, even several months after the treatment has been stopped. Therefore, a voluntary worldwide withdrawal of Zinbryta has been issued since its potential risks outweigh its serious health risks.
"Given the nature and complexity of adverse events being reported, characterizing the evolving benefit/risk profile of Zinbryta will not be possible going forward given the limited number of patients being treated," Biogen and Abbvie, Inc., said in a statement. "Therefore, Biogen and AbbVie believe it is in the best interest of patients to voluntary worldwide withdrawal."
The move came as the European Medicines Agency (EMA) moved to place an immediate suspension on Zinbryta amid reports of deaths and brain inflammation.
What is Multiple Sclerosis?
Multiple sclerosis (MS) is a chronic disease affecting the central nervous system (the brain and spinal cord). MS occurs when the immune system attacks nerve fibers and myelin sheathing (a fatty substance which surrounds/insulates healthy nerve fibers) in the brain and spinal cord. This attack causes inflammation, which destroys nerve cell processes and myelin – altering electrical messages in the brain.
MS is unpredictable and affects each patient differently – some individuals may be mildly affected, while others may lose their ability to write, speak or walk.
Relapsing Forms of Multiple Sclerosis (MS)
At the time of diagnosis, 90% of patients will have relapsing-remitting course of disease. This form of multiple sclerosis is characterized by the onset of neurological symptoms over a period of hours to days. Common symptoms of a relapse may include:
- Blurred vision, double vision or loss of vision
- Unsteady gait
These symptoms tend to persist for days or weeks, and then disappear partially or completely on their own or with treatment. Patients may then remain symptom-free for weeks, months or even years (known as remission). Without treatment, most people with MS will develop disease symptoms that will gradually worsen over time (known as relapsing).
Encephalitis is an inflammation of the brain, caused by infection or an allergic reaction, according to the Mayo Clinic. The condition often causes only mild, flu-like symptoms — such as a fever or headache — or no symptoms at all. However, in some cases, symptoms are more severe and include confused thinking, seizures, or problems with senses or movement.
Zinbryta REMS Program
While less severe side effects are common, Zinbryta is also known to have greater risks. These additional side effects include liver injury and immune conditions.
Due to those elevated risks, Zinbryta came with a black boxed warning — the strongest label warning issued by the FDA. The label warned prescribers that the drug could cause severe liver injury in which fatalities have occurred.
The boxed warning also notified prescribers of incidence of immune-mediated disorders, such as “skin reactions, lymphadenopathy, immune-mediated colitis, and other serious conditions.” These side effects were observed in 5% of patients treated with Zinbryta.
Because of the risks of hepatic injury and immune-mediated disorders, Zinbryta was only available through a Risk Evaluation Mitigation Strategy (REMS) program called the Zinbryta REMS Program.
A REMS is required by the FDA in some drugs to ensure that the benefits of prescribing a drug outweigh the risks. The drug makers will create the REMS program, and the FDA approves it. That means for the drug to be approved for use in an individual, the prescriber, patient, and pharmacist must meet very specific requirements.
For the Zinbryta REMS Program, there are three notable requirements. A prescriber must be certified in the program. A patient must be enrolled in the program and comply with ongoing monitoring. A pharmacist must be certified with the program and may only dispense the drug to authorized patients.
Who is Eligible to File Zinbryta Lawsuits?
Only a qualified attorney can determine whether you are eligible to file a lawsuit against the makers of Zinbryta, which is why we are currently offering free case evaluations. Simply fill out the confidential evaluation form below to contact our law firm now.
Most cases involving pharmaceuticals allege that a drug was sold with design, manufacturing, and/or marketing defects, which typically refers to a company’s failure to warn of a certain side effect. In the case of Zinbryta, our attorneys suspect that patients may be able to take legal action in light of claims that the manufacturer failed to adequately warn doctors and patients about the risk of severe brain disorders, liver damage, and other serious side effects.
Should I File a Zinbryta Lawsuit?
If you suffer from multiple sclerosis, you’re already facing the tremendous burden of living with a 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.
Get a Free Zinbryta Lawsuit Evaluation with our Lawyers
The Pharmaceutical Litigation Group at our law firm is an experienced team of trial lawyers that focus on the representation of plaintiffs in Zinbryta lawsuits. We are handling individual litigation nationwide and currently accepting new injury and death cases in all 50 states.
Free Case Evaluation: Again, if you were injured after taking Zinbryta, you should contact our law firm immediately. You may be entitled to compensation by filing a suit and our lawyers can help.