Cookie policy: This site uses cookies (small files stored on your computer) to simplify and improve your experience of this website. Cookies are small text files stored on the device you are using to access this website. For more information please take a look at our terms and conditions. Some parts of the site may not work properly if you choose not to accept cookies.

Join

Subscribe or Register

Existing user? Login

Modafinil use should be restricted to narcolepsy, says European Medicines Agency

By News team

Modafinil should be used for the treatment of narcolepsy only, the European Medicines Agency has advised.

Currently, modafinil is licensed for the treatment of daytime sleepiness associated with narcolepsy, obstructive sleep apnoea syndrome and chronic shift work.

However, a review by the agency’s Committee for Medicinal Products for Human Use concluded that the benefits of modafinil only outweigh the risks when used for the treatment of narcolepsy — and that all other indications should be withdrawn from the medicine’s marketing authorisation.

The review was initiated because of safety concerns about psychiatric disorders and serious skin and subcutaneous tissue reactions associated with modafinil. The CHMP found the risk of developing skin and hypersensitivity reactions to be higher in children than in adults and also recommend that modafinil should not be prescribed for people under 18 years of age.

The CHMP also identified a number of cardiovascular risks associated with the drug and advised that it should be contraindicated in patients with uncontrolled moderate-to-severe hypertension and in patients with cardiac arrhythmias.

The CHMP’s recommendations have been forwarded to the European Commission for the adoption of a binding decision valid throughout the EU. The decision-making phase usually takes two to three months and the European Commission follows the CHMP’s scientific opinion in almost all cases, a spokeswoman for the EMA told PJ Online.

 

Citation: The Pharmaceutical Journal URI: 11019071

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

  • BNF and BNF for Children

    BNF and BNF for Children

    Now available as a 1 year print subscription to both the BNF and BNFC, ensuring you have the latest medicines information as it publishes and at a greatly reduced price.

    £138.50Buy now
  • BNF and BNF for Children

    BNF and BNF for Children

    Now available as a 2 year print subscription to both the BNF and BNFC, ensuring you have the latest medicines information as it publishes and at a greatly reduced price.

    £262.50Buy now
  • Patient Care in Community Practice

    Patient Care in Community Practice

    Patient Care in Community Practice is a unique, practical guide for healthcare professionals or carers. Covers a range of non-medicinal products suitable for use at home.

    £22.00Buy now
  • Clinical Pharmacokinetics

    Clinical Pharmacokinetics

    A practical guide to the use of pharmacokinetic principles in clinical practice. Includes case studies with questions and answers.

    £33.00Buy now
  • Pharmaceutical Toxicology

    Pharmaceutical Toxicology

    Explains the methodology and requirements of pre-clinical safety assessments of new medicines. Includes registration requirements and pharmacovigilance.

    £40.00Buy now

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

Powered by MedicinesComplete
  • Print
  • Share
  • Comment
  • Save
  • Print Friendly Version of this pagePrint Get a PDF version of this webpagePDF

Supplementary images

  • Nspimages/dreamstime.com

Jobs you might like

Newsletter Sign-up

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