Pharmaceutical giants Biogen Inc. and AbbVie announced the Zinbryta recall on March 2, 2018, after a number of patients reportedly developed encephalitis or meningoencephalitis.

According to the Boston Globe, FDA representatives stated the agency was aware of the global market withdrawal of Zinbryta, and recommended that patients talk to their doctors. There have been 12 cases of Zinbryta encephalitis reported worldwide, with three of these cases being fatal.

The FDA has not specified if there have been any cases of Zinbryta encephalitis and meningoencephalitis in the U.S., or whether or not the agency intended to conduct a review like European health officials.

Health Europa reports that the European Medicines Agency (EMA) announced it had begun an “urgent review” of the drug after seven patients had reportedly developed brain inflammation in Germany and one in Spain.

The EMA recommended that doctors in the European Union not prescribe any new Zinbryta treatments to patients and that doctors should review patients taking the multiple sclerosis drug and consider different alternatives. In addition, patients must not stop taking their medications before consulting their doctor and should discuss any concerns of potential side effects with medical professionals.

The announcement of the Zinbryta recall spurred major concern in the medical community, with many noting that this is not the first time the medication has been cited for severe side effects. Previously, the FDA issued black box warnings regarding potential liver problems, while European health officials required strict patient monitoring for liver damage.

It is important to note that this Zinbryta recall is voluntary, and the pharmaceutical companies are fully cooperating with appropriate health officials.

“Biogen believes the voluntary worldwide withdrawal of Zinbryta, a treatment for relapsing multiple sclerosis, is in the best interest of patients,” said Dr. Alfred Sandrock, executive vice president and chief medical officer at Biogen, which is Massachusetts’ largest biotechnology company.

Overview of Zinbryta Complications

Zinbryta is a relatively new medication which was approved by the FDA on May 27, 2016, to treat adult patients suffering from multiple sclerosis (MS). Zinbryta is typically prescribed to patients who have not responded to two or more other MS treatment drugs.

Multiple sclerosis occurs when the immune system attacks the protective sheath around nerve cells in the brain and spinal cord, which makes up the central nervous system.

Zinbryta works by binding to immune cells, which reduces their activity. Thousands of patients took Zinbryta, most of whom were in Germany and the United States.

However, Zinbryta has long since been associated with serious health complications, with the FDA stating it has been aware of its “complex safety profile” since its approval. Most notably, Zinbryta has been linked to brain inflammation disorders encephalitis and meningoencephalitis.

Encephalitis is described as swelling of the brain that is typically caused by an infection from a virus but can also be caused by problems with the immune system. Meningoencephalitis occurs when bacteria enters the bloodstream and attacks the central nervous system, which has also been linked to Zinbryta complications.

Zinbryta patients should be aware of any signs or symptoms of brain symptoms including, but not limited to:

• Muscle pain or weakness
• Fatigue
• Fever
• Coordination problems
• Nausea or vomiting
• Delirium or hallucination
• Headache
• Seizures