The Multiple Sclerosis (MS) medication Zinbryta has been withdrawn from the worldwide market by its manufacturers Biogen and Abbvie after approximately 12 cases of inflammatory brain disorders were linked to the drug.

The pharmaceutical company publicly released its plan to take the drug off the market in early March of this year, but the process took nearly two months to complete to allow for a smooth transition to another treatment regimen for patients that were currently taking the MS medication.

The inflammatory brain disorders that had drawn attention had been under investigation by the European Medicines Agency (EMA). The inflammatory brain disorders which included encephalitis and meningoencephalitis have yet to have a proven causal relationship with Zinbryta, but there was enough evidence—albeit circumstantial—to set off alarm bells.

Of the dozen patient cases of inflammatory brain disorders reported and under investigation, three ended in the death. Typically, inflammatory brain disorders like encephalitis are brought on by a virus or bacteria invading the body. In situations where a medication is involved such as this, a compromised immune system is usually a common denominator. MS patients have this as a matter of course with their disease.

In fact, it is an indiscriminately overactive immune system which is the hallmark of MS. In this disease state, the body can not tell the difference between healthy nervous system tissue and dangerous invaders of the body. It randomly attacks the myelin sheath that covers nerve cells, spinal cord and brain interfering with communication between them and the muscular-skeletal system.

From the time Zinbryta was approved a little over two years ago by the FDA, it was viewed with caution.

The FDA referred to the medication as having a “complex safety profile” because of problems seen during clinical trials that seemed to herald the potential for liver damage and immune system risks bearing a relationship to Stevens Johnson Syndrome (SJS) and Toxic Epidermal Necrolysis (TEN). These two conditions cause serious damage to the skin that can have fatal consequences in the extreme.

The recommendation by the FDA was that it be prescribed only as a last resort for MS patients whose treatment had demonstrated less than satisfactory results with at least two other medications for the disease.

When Zinbryta made is commercial debut, it came with a black box warning on its label—the strongest warning level the FDA has in its toolbox. The black box warning contains vital risk and safety information which has bolded black font and is surrounded by a bold black box outline so that it can be clearly seen on the label.

Now that the instances of potentially related inflammatory brain disorders have come to light, the complex safety profile was underscored and put pressure on Biogen and Abbvie to remove Zinbryta from distribution. They voluntarily did so with the assistance of the FDA with a completion date of April 30, 2018.

If you or a loved one were one of the many patients taking Zinbryta that suffered either hepatic injury, symptoms of immune malfunction or encephalitis-type brain events, you may have a legal claim. Fill out our form to request a consultation.