The U.S. Food and Drug Administration (FDA) is looking at whether encephalitic brain inflammation is connected with Zinbryta, a multiple sclerosis (MS) drug marketed by AbbVie and Biogen. The FDA wants to know if encephalitis (brain inflammation) is a side effect of the drug. Encephalitis can lead to permanent brain injuries and fatalities. AbbVie and Biogen voluntarily recalled the drug globally on March 2, 2018, the same day that the European Medicines Agency announced a review of the medication. The drug was sold in the United States, Canada, Switzerland, the European Union and Australia. There were 12 reports of brain inflammation worldwide. Three deaths resulted. All of them were in the United States. The first Zinbryta brain inflammation lawsuit could be filed shortly.
The Black Box Warning
The FDA stated that it has been aware of “the complex safety profile of Zinbryta” since the date of its approval. With only two years on the market, it already carries a black box warning in connection with the risk of liver injury and immune disorders. When a black box warning is mandated by the FDA, there is reasonable evidence of a connection between the drug and severe side effects.
$87,000 a Year?
Zinbryta was approved in the United States in 2016 for treating those with relapsing MS. Upon a relapse, new or increased symptoms appear. Since MS is a progressive disease, recovery gets more difficult, and the patient’s condition continues to decline. It’s injected monthly at a cost of $87,000 per year. It came with a warning of the risk of liver damage. As per the Multiple Sclerosis Society, the neurological disease affects about 2.3 million people in the world. MS scars nerve tissue, and it’s known to cause vision issues and paralysis.
Zinbryta Restrictions
People who use medications that affect the liver or have liver disease, eczema or psoriasis aren’t suitable candidates for Zinbryta. Even if somebody wants to use the medication, he or she must have tried at least two other types of treatment and cannot be on any other MS medications. Zinbryta was only available through a restricted distribution program that required periodic monitoring. Both the patient’s doctor and pharmacist were required to be registered with the program in order for the patient to use the drug.
Some Common Symptoms of Encephalitis
Encephalitis involves inflammation of brain tissue. It can be caused by bacterial infection, viral infection or an immune disorder. Some of the symptoms of encephalitis include:
- Persistent fever
- Severe headaches
- Stiff neck
- Coordination issues
- Nausea
- Vomiting
- Yellowing of skin
- Yellowing of eyes
When it was introduced to the market, Zinbryta was believed to be safer than a competing treatment for the same disorder, but one health care analytics company found the rate of serious side effects from the medication to be higher. As per efficacy, Zinbryta has the advantage.
The FDA is now investigating if there might be a connection between encephalitis and Zinbytra. It’s also working with the manufacturers of the drug to assist in their voluntary recall. It will also advise doctors, pharmacists and other health care professionals regarding their need to seek other treatment options for MS sufferers. Zinbytra significantly reduced annual relapse rates along with the average number of brain lesions in MS patients. Prior to the possible connection between Zinbytra and encephalitis, the drug’s most common side effects were unrelated to the disease.
A determination will be made shortly on whether a brain inflammation lawsuit will be brought against the manufacturers of Zinbytra. It’s more likely than not.
Learn more about Drug Safety Lawsuits.