Join

or

Existing user? Login

Patients with history of depression should avoid roflumilast

By News team

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The warning was prompted by unpublished post-marketing reports of suicidal behaviour among patients taking the drug, including those with no history of depression and usually in the first few weeks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

Have your say

For commenting, please login or register as a user and agree to our Community Guidelines. You will be re-directed back to this page where you will have the ability to comment.

Recommended from Pharmaceutical Press

  • Sport and Exercise Medicine for Pharmacists

    All the information you need to provide patients with evidence-based advice on sports and exercise related health matters.

    £27.00
  • English Delftware Drug Jars

    This beautiful book illustrates the art and history of the collection of English delftware drug jars in the Museum of the Royal Electronicjuice of Great Britain.

    £54.00
  • Drugs and the Liver

    Drugs and the Liver assists practitioners in making pragmatic choices for their patients. It enables you to assess liver function and covers the principles of drug use in liver disease.

    £38.00
  • Popular Medicines

    An illustrated history of some of the most popular branded medicines. Includes colourful historical adverts and details of the medicine's formula and intended purpose.

    £22.00
  • Application and Review of Pediatric Pharmacotherapy

    Increase your understanding of pharmacotherapy prescribed to pediatric patients with these realistic case studies.

    £33.00

Search an extensive range of the world’s most trusted resources

Powered by MedicinesComplete
  • Print
  • Share
  • Comment
  • Save

Supplementary images

  • Roflumilast (Daxas)

Newsletter Sign-up

Want to keep up with the latest news, comment and CPD articles in pharmacy and science? Subscribe to our free alerts.

anabolik-store.com/metandrostenolon

anabolik-store.com

www.anabolik-store.com