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On March 14, 2018, the Food and Drug Administration (FDA) announced on its website that drugmakers Biogen and Abbvie were voluntarily withdrawing daclizumab (ZINBRYTA) — which was approved by the FDA in May 2016 to treat adult patients with relapsing forms of multiple sclerosis[1] — from all markets across the globe because of concern about the drug’s “evolving benefit/risk profile.”[2]
Acting more promptly, the European Medicines Agency (EMA), a regulatory agency similar to the FDA,...
On March 14, 2018, the Food and Drug Administration (FDA) announced on its website that drugmakers Biogen and Abbvie were voluntarily withdrawing daclizumab (ZINBRYTA) — which was approved by the FDA in May 2016 to treat adult patients with relapsing forms of multiple sclerosis[1] — from all markets across the globe because of concern about the drug’s “evolving benefit/risk profile.”[2]
Acting more promptly, the European Medicines Agency (EMA), a regulatory agency similar to the FDA, on March 7 announced that it had recommended the immediate marketing suspension and recall of daclizumab because of evidence of severe adverse reactions affecting the brain.[3] In particular, there have been 12 reports worldwide of serious inflammatory brain disorders, including encephalitis (inflammation of the brain) and meningoencephalitis (inflammation of the brain and the outer membranes that cover the brain and spinal cord). Three of these cases were fatal. A preliminary review of the evidence indicated that these adverse reactions may be linked to use of daclizumab. Most of the cases occurred within eight months of starting the drug.
The EMA also noted that daclizumab may be linked to severe immune reactions targeting the blood cells and organs besides the brain, including the liver, thyroid gland and kidneys. The EMA advised health care professionals not to start any new patients on daclizumab and to stop the drug as soon as possible in any patient who is currently using it.
The EMA also offered the following advice to patients:
- If you are being treated with daclizumab, contact your doctor to discuss treatment.
- Do not take another injection of the drug.
- Tell your doctor immediately if you have persistent high fever, severe headache, nausea, vomiting or yellowing of the skin or eyes. These could be signs of a reaction to daclizumab.
The EMA noted that these adverse reactions can occur up to six months after treatment with daclizumab has been stopped. Therefore, especially during these months, patients should be monitored.
References
[1] Biogen Inc. Drug label: daclizumab (ZINBRYNTA). August 2017. https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/761029s007lbl.pdf. Accessed April 12, 2018.
[2] Food and Drug Administration. FDA working with manufacturers to withdraw Zinbryta from the market in the United States. March 14, 2018. https://www.fda.gov/drugs/drugsafety/ucm600999.htm. Accessed April 12, 2018.
[3] European Medicine Agency. EMA recommends immediate suspension and recall of multiple sclerosis medicine Zinbryta. March 7, 2018. http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2018/03/news_detail_002920.jsp&mid=WC0b01ac058004d5c1. Accessed April 12, 2018.
