A preliminary review of the available evidence indicates that immune reactions observed in the reported cases may be linked to the use of daclizumab. It may also be linked to severe immune reactions affecting several other organs.
The EMA also relays the following advice:
Information for patients:
• If you are being treated with daclizumab, contact your doctor to discuss your treatment.• Do not take another injection of daclizumab.• Tell your doctor immediately if you have or experience symptoms such as persistent high temperature, severe headache, nausea (feeling sick), tiredness, yellowing of the skin or eyes and vomiting. These could be signs of a reaction to daclizumab.• Your doctor will carry out regular blood tests for up to 6 months after stopping treatment to check for side effects.• If you are in a clinical study with daclizumab, contact the doctor treating you in the study.
Information for healthcare professionals:
• Do not start any new patients on daclizumab.• Contact your patients currently being treated with daclizumab as soon as possible and stop their treatment. Consider alternative treatments as appropriate.• Patients stopping treatment should be monitored at least monthly and more frequently as clinically indicated for up to 6 months after the last dose of daclizumab.• Advise patients to immediately report symptoms of liver injury such as prolonged fever, severe headache, tiredness, jaundice, nausea or vomiting. These reactions can occur for 6 months after treatment has been stopped.• A recall of daclizumab will take place from pharmacies and hospitals across the EU.