The review of daclizumab started after the death from fulminant liver failure of a patient involved in an ongoing observational study, as well as four cases of serious liver injury. The risk of liver damage with the medicine was already known at time of its approval in the EU, and several measures were in place to manage this risk, including the requirement to monitor liver function and provide educational materials to healthcare professionals and patients on the risk of liver damage. The European Medicines Agency has provisionally restricted use to patients with highly active relapsing disease that has failed to respond to certain other treatment, and to patients with rapidly evolving relapsing disease who cannot be treated with other medicines. In addition, patients with liver injury must not be given the medicine. Starting treatment not recommended for patients with autoimmune diseases other than multiple sclerosis and caution should be used when giving it together with medicines that can damage the liver. Doctors are advised to continue to monitor the liver function of patients receiving the drug and closely watch patients for signs and symptoms of liver injury.
A Drug Safety Update on this risk has also been published by MHRA.