Zinbryta will be pulled from United States markets in cooperation with the FDA over the coming months due to a risk of a possible inflammatory brain disorder.  Studies and trials indicate that patients taking the drug could develop severe side effects including a brain disorder, prompting the company to initiate their own withdrawal.

Manufacturers AbbVie and Biogen have announced a voluntary withdrawal of the drug, noting concern about the benefit and risk profile, and in particular the number of patients who have come forward to report an inflammatory brain disorder.

Zinbryta is a multiple sclerosis medication. The Food and Drug Administration is currently working closely with those manufacturers to ensure that the withdrawal from the market is organized effectively and to verify that all health care professionals have the information they need to transition patients to other forms of treatment options.

According to information released by the FDA, the risk of the inflammatory brain disorder and other serious side effects prompted the manufacturers to issue a voluntary recall.

The drug will be available for patients on an as-needed basis until April 30th, 2018. The manufacturers have already begun notifying health care professionals as well as patients, since no new patients will be able to participate in clinical studies or take Zinbryta after this point in time.

Any patient who is currently using Zinbryta may wish to schedule a consultation with their physician about the risk of an inflammatory brain disorder. Anyone taking the medication should not discontinue their usage until they have spoken directly to their physician. Anyone who has experienced any unexplained and new symptoms should schedule an appointment with their doctor immediately.

The European Medicines Agency already recalled Zinbryta after 12 reports from patients alleging a serious inflammatory brain disorder. The Food and Drug Administration has shared that they are aware of those reports and are completing their own review of similar events.

FDA Monitored Adverse Event Reports from Patients

The FDA has continued to monitor adverse event reports filed by patients, including those associated with any claim of an inflammatory brain disorder. The FDA says that they have updated product labeling as necessary and as new information became available.

Typically, the drug safety profile has been associated with risks from its initial approval. Those patients who had an inadequate response to two or more other multiple sclerosis drugs may have been appropriate for Zinbryta.

However, there has also been a boxed warning associated with this drug regarding immune mediated disorders and the risk of liver injury. The drug was only available to patients previously through restricted distribution program, but they still posed a risk of dangerous side effects including an inflammatory brain disorder.

Most drugs carry some risk of side effects, but when the symptoms are not clearly represented to patients or the medical community, this may prompt recalls or even lawsuits. Any patient who is taking Zinbryta or knows someone who has should discuss alternative treatment options with a medical provider immediately.