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Citalopram and heart problems - changes to recommended doses

Safety advisory

4 November 2011

The TGA is advising that citalopram should no longer be used at doses greater than 40 mg per day. For some patients, the maximum recommended dose is now only 20 mg per day (see below).

In addition, it is now advised that people who have been diagnosed with a heart condition known as "congenital long QT syndrome" should not take citalopram.

A recent study by the Forest Research Institute in the USA has shown that higher doses of citalopram can cause abnormal changes in the electrical activity of the heart. In rare cases these changes can result in serious heart problems.

Citalopram is a member of the class of drugs called selective serotonin reuptake inhibitors (SSRIs) and is used to treat major depression. Brand names include:

  • Cipramil
  • Celapram
  • Talam
  • Ciazil
  • Citalobell
  • Celica
  • Pharmacor Citalo 20 and
  • others with the word "citalopram" in their name

Information for patients

You should talk to your doctor about changing your dose if:

  • You are taking more than 40 mg of citalopram a day
  • You are taking more than 20mg per day and:
    • are over 65 years of age
    • have reduced liver function or
    • are also taking medicines, such as cimetidine or omeprazole, which interfere with the metabolism of citalopram.

You should talk to your doctor about changing your treatment if:

  • You have been diagnosed with congenital long QT syndrome.

You should NOT stop taking citalopram or change the dose without first consulting your doctor. Stopping citalopram suddenly may result in withdrawal symptoms including:

  • dizziness
  • anxiety
  • insomnia
  • emotional instability
  • headache
  • diarrhoea
  • vomiting
  • palpitations.

Information for health professionals

The recent study found dose-dependent QT prolongation with citalopram. As higher doses may result in life-threatening or fatal arrhythmias in some people, the following new dosage recommendations and contraindications are advised:

The maximum recommended daily dose of citalopram is now 40 mg.

A maximum recommended daily dose of 20 mg now applies to patients:

  • greater than 65 years of age
  • with liver dysfunction
  • with poor CYP2C19 activity or
  • taking concomitant CYP2C19 inhibitors (eg cimetidine or omeprazole).

In patients aged over 65 years, the recommended starting dose is now 10 mg daily.

Citalopram should not be used in patients with congenital long QT syndrome.

Citalopram should be used with caution in patients at higher risk of developing prolongation of the QT interval, including those with:

  • congestive heart failure
  • bradyarrhythmias
  • predisposition to hypokalaemia
  • predisposition to hypomagnesaemia
  • concomitant medicines that prolong the QT interval.

There are new monitoring recommendations for patients on citalopram:

  • Hypokalaemia and hypomagnesaemia should be corrected prior to initiation of treatment and potassium and magnesium levels should be periodically monitored.
  • More frequent ECG monitoring should be considered for patients at higher risk of QT prolongation.

If citalopram is discontinued or the dose reduced, the patient should be monitored closely for the re-emergence or worsening of any symptoms of depression.

The sponsor of Cipramil (citalopram hydrobromide), Lundbeck Australia, is writing to health professionals advising them of these changes.

The Product Information documents for citalopram products will be updated with the findings of the study and the new recommendations.

Reporting an adverse event

Consumers and healthcare professionals are encouraged to report adverse reactions associated with citalopram to the TGA, including cases of QT interval prolongation and torsade de pointes. Your report will contribute to our monitoring of this medicine.

The TGA cannot give personal advice about an individual's medical condition. Consumers are strongly encouraged to talk with a health professional if they are concerned about a possible adverse reaction to any medicine.