In October 2011, the European Pharmacovigilance Working Party has concluded to reduce the maximum dose of the antidepressant medicine citalopram. The recommendation follows from a drug trial and adverse reactions showing that citalopram may affect the heart rhythm, especially when given in high doses. The new recommended maximum daily dose is 40 mg in adults and 20 mg in the elderly and patients with impaired liver function. Citalopram should not be used in children and adolescents under the age of 18.
The Danish Medicines Agency is represented in the EU Pharmacovigilance Working Party and endorses the dose adjustment. It will be a few months before the package leaflets are updated with the lower dose.
Citalopram is an antidepressant drug of the SSRI type (selective serotonin reuptake inhibitor), which is used, among other things, for the treatment of moderate to severe depression and panic disorder.
Information for persons taking citalopram:
- Persons treated with citalopram are advised not to stop taking citalopram or change or reduce the dose without first consulting a doctor, as withdrawal symptoms may occur when citalopram treatment is discontinued, particularly if treatment is stopped suddenly (please see the package leaflet supplied with the medicine for further details).
- Persons taking citalopram should contact a doctor immediately if they experience signs and symptoms of an abnormal heart rhythm while taking citalopram such as chest discomfort, dizziness or fainting.
Information for prescribers of citalopram:
- Citalopram has been linked with a dose-dependent increase in QT interval.
- From now on, the recommended dose of citalopram is 40 mg/day.
- In the elderly and in patients with hepatic impairment the maximum dose is reduced to 20 mg/day.
- Persons with a known increase in QT interval, including congenital long QT syndrome, must not use citalopram (contraindicated).
- Use of citalopram with other medicines known to prolong the QT interval is contraindicated.
- Citalopram should be used cautiously in patients at increased risk of developing torsade de pointes. This includes, for example, patients with heart failure, recent myocardial infarction, bradyarrhythmia or patients predisposed to hypokalaemia or hypomagnesaemia as a result of other disease, or if they take other medicine concurrently.