Voluntary Withdrawal of Zinbryta from the Market After Concerns Arise Over Liver and Brain Damage

The drug Zinbryta has been recalled on a voluntary basis by its manufacturers according to the recommendation of the European Medicines Agency (EMA) in cooperation with the Food & Drug Administration (FDA).

Zinbryta (daclizumab) was approved by the FDA in May 2016 for the treatment of individuals suffering from various relapses of multiple sclerosis (MS). The use of the drug has been limited to approximately 8000 patients with MS in the wake of reports of serious health issues resulting from its use.

The disease of multiple sclerosis

Multiple sclerosis is a debilitating disease that attacks an individual’s central nervous system by triggering the immune system to mistakenly attack and cause significant damage to the protective covering around the nerve cells. Today, the cause of MS is unknown, with some theorizing that genetically predisposed individuals may react to certain environmental factors, leading to the development of the disease.

Zinbryta functions in the body by decreasing the activity of cells that harm the immune system. The active ingredient involved – daclizumab – attaches itself to immune cells in order to minimize these attacks.

Side effects of Zinbryta

Zinbryta has existed on the market for just a short time, yet has already received a black box warning from the FDA. The global recall of the drug has been encouraged due to reports of debilitating conditions such as hepatic injury, inflammatory brain disorders, severe skin reactions (such as Stevens-Johnson Syndrome), and liver failure.

A dangerous drug injury lawsuit involving Zinbryta may be pursued due to one or more of the following injuries or complications:

• Inflammatory encephalitis
• Liver injury or failure
• Erythema multiforme major
• Stevens Johnson Syndrome (SJS)
• Hepatitis induced by drug use
• Additional immune-medicated disorders
• Wrongful death

Zinbryta causes global concern

Among those who have been prescribed Zinbryta, at least 12 individuals suffered serious brain inflammation, among which 3 lost their lives. Subsequently, the FDA was prompted to begin an investigation to reevaluate the profile of the drug. These reports also raised concerns among physicians related to the prescribing of Zinbryta to patients.

Due to the reports of its increased side effects, a Risk Evaluation and Mitigation Strategy was implemented. Zinbryta was prescribed most often as a last resort to patients having unsuccessful reactions to two or more other drugs designed to treat MS.

Zinbryta to be withdrawn from the global market

Biogen and AbbVie, the manufacturers of Zinbryta, asserted in a statement that due to the small number of patients having used the drug, monitoring the adverse events linked to its use is difficult.

However, on March 2, 2018 the manufacturers voluntarily issued a global recall of Zinbryta from the biochemical market. The FDA subsequently issued a statement concerning the withdrawal of Zinbryta from the market.

The EMA provided recommendations to doctors to immediately halt the use of Zinbryta in patient treatment regimens and to prescribe other medicines instead. The drug was to be available to physicians until April 30, 2018 on an as-required basis. The agency also recommended doctors to perform follow-ups with patients for a minimum of six months in order to monitor any indications of liver damage or brain inflammation. Prior to discontinuing use of the drug, patients are encouraged to consult with their physician or healthcare provider. Patients should inform their doctor immediately if any unusual or new symptoms manifest.

If you have taken a prescribed medication such as Zinbryta or any other dangerous drug that has caused you harm, you may have a legitimate claim for compensation. Our team at McGowan, Hood, Felder & Phillips, LLC, can work vigorously on your behalf to hold any negligent parties, including the manufacturer or seller of the dangerous or defective drug accountable for your injury, pain, and losses. To set up a free, no-obligation appointment about your case, call us today at 803-327-7800 or complete our contact form.