Patients with history of depression should avoid roflumilast
is not recommended for patients with a history of depression associated with suicidal ideation or behaviour, warns the latest Drug Safety Update from the Medicines and Healthcare products Regulatory Agency.
January’s DSU also warns of the risk of serious liver injury with and of bradycardia and heart block in patients restarted on after a treatment interuption (see Panel).
Use of roflumilast should be avoided in patients with previous or existing psychiatric symptoms, and treatment discontinued if new or worsening symptoms occur, the DSU says. Patients and caregivers should be told to report any suicidal ideation or changes in behaviour or mood.
The warning was prompted by unpublished post-marketing reports of suicidal behaviour among patients taking the drug, including those with no history of depression and usually in the first few weeks of treatment.
Clinical trials had already shown roflumilast to be associated with suicidal behaviour in as many as 1 in 1,000 patients, and linked treatment with an increased risk of insomnia, anxiety, nervousness and depression.
DSU on lenalidomide and fingolimod
Routine monitoring of liver function is recommended for patients receiving lenalidomide, particularly those who have a history of viral liver infection or are taking other medicines linked with liver injury, January’s Drug Safety Update warns.
Impairment of liver function generally resolves when lenalidomide is stopped, and restarting treatment at a lower dose can be considered once a patient’s liver function parameters have returned to baseline. Dose adjustments are needed for patients with renal impairment, the DSU says.
It also details the enhanced cardiovascular monitoring that is required when fingolimod is restarted after treatment interruption. Recommendations for monitoring heart activity at the start of fingolimod treatment were set out by the European Medicines Agency last April (PJ 2012;288:508).
Citation: Electronicjuice DOI: 10.1211/PJ.2013.11116594
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