A drug for MS already withdrawn due to serious risks of side effects has come under fire again with the European Medicines Agency.

In May, the EMA announced that Zinbryta, a previously used treatment for patients with multiple sclerosis, has been linked to immune reactions and issues in the brain as well as problems with other body organs like the liver. The Pharmacovigilance Risk Assessment Committee for the European Medicines Agency determined that the liver and brain could be injured by taking Zinbryta.

Although Zinbryta was always recommended as somewhat of a last resort for MS sufferers, patients may not have been fully aware of the risk of severe brain problems and other side effects. Any medicine comes with the risk of side effects and problems, but users of some drugs argue that they were never told about the possibility of life-changing problems and were therefore put at risk.

According to the newly released information from the EMA, fatal immune reactions can happen in the brain. The EMA says that 12 cases of inflammatory brain issues were recorded in patients who might have used the Zinbryta drug for MS.

Three deaths were tied to cases of meningoencephalitis and encephalitis. These conditions involve inflammation of the spinal cord and brain. The EMA determined that because of these serious issues, the possible benefits of Zinbryta do not outweigh the risk profile for patients. Zinbryta, however, has already been pulled out of European pharmacies.

The Zinbryta drug for MS originally came on the market in 2016 for the purpose of helping patients with relapsing MS. Since that point in time, an estimated 10,000 patients received the drug. Brain inflammation, however, was one serious side effect about which some patients say they were never warned.

Due to the risks of brain inflammation and other issues, manufacturers AbbVie and Biogen pulled the drug from the market in 2018. Even though the drug is not an option for a current patient, others who used it in the past could still be at risk of developing problematic side effects. According to research, the brain inflammation and liver issues could develop months after the patient begins the regimen.

Previously, the EMA has recommended that doctors follow up with those patients who took Zinbryta for at least six months following the end of their treatment course with the drug. Someone who suddenly develops any of the side effects listed above should be prepared to share their concerns with their doctor immediately.

An inflammatory brain disorder of any type should be taken seriously, since this condition can worsen without medicine intervention. Two kinds of inflammatory brain disorders associated with Zinbryta are encephalitis and meningoencephalitis. Both conditions can be fatal if not caught quickly. The first involves swelling of the brain due to a viral infection or issues with the patient’s immune system.

The second condition occurs when bacteria enter the patient’s bloodstream and goes to the spinal cord or the brain, leading to acute bacterial meningitis.