The multiple sclerosis medication Zinbryta has, since its approval, been linked with some serious side effects, eventually resulting in a manufacturer-led recall of the drug in March 2018.

A recent Zinbryta review published in a Spanish medical journal brings up some essential issues with the drug-approval process that Zinbryta underwent.

Basics of Zinbryta

Zinbryta (daclizumab) is a new multiple sclerosis drug manufactured jointly by Biogen and AbbVie. Zinbryta was in development for years and was approved by the U.S. Food and Drug Administration (FDA) in May 2016.

Multiple sclerosis (MS) is a condition that involves the immune system attacking and damaging the protections around the central nervous system. Zinbryta is far from the first MS drug available, but it is meant to add options for patients who have not found two or more MS drugs effective.

However, along with Zinbryta’s approval, the FDA also noted that the drug should be focused on patients who have already tried two or more other multiple sclerosis drug options.

It should not be the first option available to patients, the FDA noted, “because Zinbryta has serious safety risks, including liver injury and immune conditions.” At the time, the FDA did not include the risk of brain inflammation.

Since Zinbryta’s approval, however, the European Medicines Agency (EMA) announced that it was conducting a Zinbryta review to look into reports of side effects, including eight reports of serious brain inflammation disorders. A month after this announcement, Biogen and AbbVie announced its Zinbryta recall.

Now, the Spanish Zinbryta review is looking into the development of the drug, finding that it showed serious safety problems early in its development. The authors of this Zinbryta review found that development of new MS medications “must be contingent upon maintaining or improving the risk-benefit profile with respect to those already in use.”

Indeed, there’s not much point of adding new MS drugs to the market that carry more risks than those already available.

Zinbryta Side Effects

Unfortunately, Zinbryta has been associated with a number of serious side effects, one of the most significant of which is Zinbryta brain inflammation. Brain tissue inflammation is also known as encephalitis, and is often caused by a bacterial or viral infection. However, it can also be caused by an immune system disorder.

Symptoms of Zinbryta brain inflammation are similar to those of the flu, and can last for two or even three weeks. Symptoms include muscle pain, fatigue, fever, nausea or vomiting, irritability, light sensitivity, headache, seizures, and more.

Other major Zinbryta side effects include:

• Encephalitis and other immune reactions
• Liver failure and injury
• Stevens Johnson syndrome

The Zinbryta Recall

After receiving reports from patients over a slew of side effects, Zinbryta’s manufacturers issued a voluntary recall of their multiple sclerosis drug due to reports of Zinbryta brain inflammation, including encephalitis and meningoencephalitis.

The Zinbryta recall is relatively relaxed, as the drug isn’t being pulled immediately. The FDA announced that “no new patients will start taking Zinbryta or participate in clinical studies,” and it was available for use until April 30, 2018.

Filing a Zinbryta Brain Inflammation Lawsuit

If you or someone you love has suffered from Zinbryta brain inflammation or other side effects after using this multiple sclerosis drug, you may be able to file a lawsuit.

Filing a lawsuit cannot take away the pain and suffering caused by Zinbryta brain inflammation and other major complications, but it can help to alleviate the financial burden caused by medical expenses and lost wages.