Volume 6, Issue 6 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:
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 A recent review of postmarketing data (unpublished) has found that cases of suicidal behaviour have also been reported postmarketing, and suggests that suicidal behaviour was seen in patients with and without a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:
BNF section 3.3: Phosphodiesterase type-4 inhibitors
Article citation: Drug Safety Update January 2013, vol 6, issue 6: S2