Drug Safety Update

Volume 6, Issue 6 January 2013

Latest advice for medicines users

Roflumilast (Daxas▼): risk of suicidal behaviour – avoid use in patients with previous or existing psychiatric symptoms and discontinue treatment if new or worsening psychiatric symptoms occur

Article date: January 2013

Roflumilast (Daxas▼) is a phosphodiesterase-type-4 (PDE4) inhibitor used for maintenance treatment of severe chronic obstructive pulmonary disease (COPD) associated with chronic bronchitis. It is indicated for adult patients with a history of frequent exacerbations as ‘add-on’ to bronchodilator treatment. The recommended dose is one 500 microgram tablet daily.

From clinical trial data, roflumilast is known to be associated with an increased risk of psychiatric disorders such as:

  • insomnia (in 100 - 1000 out of every 10 000 patients)
  • anxiety (in 10 - 100 out of every 10 000 patients)
  • nervousness and depression (in 1 - 10 out of every 10 000 patients).

Rare instances of suicidal ideation and behaviour, including completed suicide, have been also observed in patients using roflumilast (in 1 - 10 out of 10 000 patients). A recent review of postmarketing data (unpublished) has found that cases of suicidal behaviour have also been reported postmarketing, and suggests that suicidal behaviour was seen in patients with and without a history of depression, usually in the first weeks of treatment.

If patients have existing psychiatric symptoms, or if concomitant treatment is intended with other medicines likely to cause psychiatric symptoms, roflumilast treatment should only be started or continued after careful assessment of the benefits and risks.

Advice for healthcare professionals:

  • Roflumilast is not recommended for patients with a history of depression associated with suicidal ideation or behaviour
  • Patients and caregivers should be asked to notify the prescriber and their healthcare provider of any changes to behaviour or mood, and any suicidal ideation. Such symptoms include preoccupation with suicidal thoughts, and self-harm.
  • Roflumilast should be discontinued if new or worsening psychiatric symptoms or suicidal behaviour are identified.

Further information:

BNF section 3.3: Phosphodiesterase type-4 inhibitors

Article citation: Drug Safety Update January 2013, vol 6, issue 6: S2

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Page last modified: 30 January 2013