The FDA approved Zinbryta for the treatment of adults with relapsing multiple sclerosis. However, just two years later, the drug manufacturers Biogen and AbbVie pulled the medication from the global market due to overwhelming reports of severe side effects of brain inflammation. The voluntary worldwide withdrawal came the same day the European Medicines Agency announced it was looking into at least seven cases of inflammatory encephalitis and meningoencephalitis.
In May 2016, the FDA approved Zinbryta (daclizumab) to treat adults with relapsing forms of multiple sclerosis (MS). MS is a disease that affects the central nervous system and disrupts the flow of information within the brain and between the brain and the body. A person with MS has attacks followed by periods of recovery. These relapses showcase new or increasing neurologic symptoms. Unfortunately, over time there are fewer periods of recovery. This makes MS patients desperate for options. However, those with MS should not use Zinbryta if he or she did not have positive responses to two or more other drugs designed to treat MS.
Zinbryta Side Effects
Zinbryta has many side effects. Also, many are serious. Complications include:
- Serious immune reactions (i.e. encephalitis)
- Liver failure
- Serious skin reactions (i.e. erythema multiforme)
Additionally, Zinbryta can cause Stevens-Johnson Syndrome (SJS). SJS can turn into Toxic Epidermal Necrolysis (TEN). This is a potentially life-threatening membrane and skin disorder that resembles a severe skin burn.
Zinbryta REMS Program
The FDA gave Zinbryta a black box warning since the medicine can cause liver injury and immune conditions. This is the strongest FDA label warning. Zinbryta’s liver injury side effect can cause death. Included in the warning are skin reactions, lymphadenopathy, immune-mediated colitis, and other serious conditions.
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. The FDA required the REMS to ensure that the benefits of prescribing a drug outweigh the risks. Drug makers create the 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. Also, a pharmacist must be certified with the program and may only dispense the drug to authorized patients.
EMA Conducts Zinbryta Patient Review
In June 2017, the European Medicines Agency (EMA), the European equivalent of the FDA, initiated a review of Zinbryta due to safety concerns. Concluding in November 2017, the EMA implemented additional restrictions to reduce the risk of liver damage. The agency found that liver injury can still happen even 6 months after stopping the medication. Almost 2% of those taking the drug had a serious liver reaction.
The restriction added was that only patients who had tried at least two other disease-modifying treatments (DMTs) and could not be treated with any other DMTs should have a doctor prescribe Zinbryta. Also, healthcare professionals should carefully monitor patients up to 6 months following treatment.
In March 2018, Biogen and AbbVie announced a voluntary worldwide withdrawal of the drug. The companies stated that the benefit to risk ratio no longer served the small number of patients using the medication. Suspiciously, the announcement came the same day as the EMA started an “urgent review” of the drug following 8 cases of serious inflammatory brain disorders. These brain disorders included encephalitis and meningoencephalitis.
Four days later, the agency recommended the immediate suspension and recall of the medication. It found 12 reports of inflammatory brain disorders around the world. Three of the cases were fatal.
We Want to Help Zinbryta Victims
Undeniably, it is your right to be informed about the long-term risks associated with the medications you take, and it is the responsibility of drug companies to provide this information. If you or a loved one took Zinbryta and suffered drug-induced liver injury, you should demand accountability. We want to also help send a message that this is not acceptable. We are advocates for consumers who have been harmed by dangerous products, and we have the experience necessary to successfully litigate these cases.
Contact the Michael Brady Lynch Firm today for a free consultation to learn more about seeking justice. Compensation may be available for any medical expenses associated with this ordeal, as well as for your physical and emotional suffering. There is no obligation.
How We Can Help
When you experience side effects from a dangerous drug, it can have devastating effects on your entire life. A verdict or settlement may give you compensation for their injuries and damages. The types of recoverable losses are:
- Past and future medical expenses
- Lost wages
- Loss of an ability to work; and
- Pain and suffering
Also, if a person dies from complications from a drug, family members may be able to recover damages for the wrongful death of their loved one, including:
- Funeral expenses
- Medical expenses prior to death
- Loss of economic support; and
- Loss of companionship
If a jury finds the conduct of a drug company in manufacturing and selling a drug to be highly reckless, they may award punitive damages. These damages aim to punish the company and deter similar conduct in the future. Therefore, if you suffered drug-induced liver injury from Zinbryta, please speak to us to learn more about your rights.