By Kim Gale  |  July 13, 2018

Category: Legal News

Zinbryta Pulled from Market After a Dozen Reports to Brain Inflammation, Three DeathsMultiple sclerosis medication Zinbryta has been linked with a variety of ailments that involve brain inflammation.

A minimum of 12 incidents of encephalitis have been reported throughout the world, and three of those cases have been deadly.

Zinbryta (daclizumab) is made by Biogen and AbbVie. The drug manufacturers announced in March 2018 that they were conducting a voluntary worldwide withdraw of Zinbryta because of too many reports of dangerous brain inflammation.

Biogen and AbbVie sent a letter to patients indicating Zinbryta would no longer be available as of April 30, 2018. The letter noted, “Due to the increasingly complicated benefit/risk profile of Zinbryta, we believe it is in the best interest of patients to withdraw Zinbryta.”

The letter also instructed patients to continue monthly liver monitoring for six months after taking the last dose of Zinbryta even if symptoms of liver problems are not present. The letter also advised patients to contact a healthcare provider immediately regarding any new or unexplained issues affecting any part of the body occurred up to six months after taking that last dose of Zinbryta.

Zinbryta Brain Inflammation Problems

Brain inflammation is associated with encephalitis and meningoencephalitis. Encephalitis includes brain inflammation only. Meningoencephalitis consists of brain inflammation and inflammation of the meninges, which are the membranes surrounding the brain. Zinbryta has been associated with both conditions.

While some patients exhibit no symptoms, common signs of encephalitis include muscle pain and weakness, fatigue, fever, coordination issues, disorientation, headache, and light sensitivity.

Others may begin vomiting, complain of a stiff neck, experience hallucinations or suffer from seizures.

The FDA is continuing to evaluate all the adverse event reports it has received regarding Zinbryta, but the FDA did not order the drug to be removed from the market. The FDA did assist with the timeline for the withdrawal of Zinbryta from the market.

Although the FDA did not order the withdrawal of Zinbryta, the regulating agency does say that the drug had a “complex safety profile” that led the FDA to recommend Zinbryta only when two or more other multiple sclerosis drugs failed to generate an adequate response in the patient.

A boxed warning regarding the risk of liver problems and of other immune-mediated disorders (including life-threatening Stevens Johnson Syndrome and Toxic Epidermal Necrolysis) led to Zinbryta being available through a restricted distribution program.

Multiple sclerosis causes the immune system to attack and damage myelin, which is the protective sheath over the nerve cells in the brain and spine. Zinbryta worked by binding to the immune cells, helping stop these immune cells from attacking the myelin.

Patients who have suffered from brain inflammation injuries or severe immune system reactions such as Stevens Johnson Syndrome allege that Biogen and AbbVie never warned them of these potentially dangerous – sometimes deadly – side effects.

If you took Zinbryta and experienced brain inflammation, severe liver damage, Stevens Johnson Syndrome or other adverse reaction, you could be eligible for compensation through legal representation.

Join a Free Zinbryta Class Action Lawsuit Investigation

If you or a loved one were diagnosed with encephalitis, liver injury, Stevens Johnson Syndrome (SJS), Toxic Epidermal Necrolysis (TEN), or another complication after taking Zinbryta, you may have a legal claim. Filing a Zinbryta lawsuit or joining this Zinbryta class action lawsuit investigation could help you recover compensation for medical bills, pain and suffering, and more.

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