Agomelatine hepatotoxicity warning

The MHRA has issued updated monitoring guidance for the antidepressant agomelatine.

Agomelatine is an antidepressant indicated for the treatment of major depressive episodes in adults.
Agomelatine is an antidepressant indicated for the treatment of major depressive episodes in adults.

The MHRA has updated the warnings and monitoring guidance for patients treated with agomelatine (Valdoxan) following reports of serious cases of dose-related hepatotoxicity associated with use of the drug.

Liver function tests

The existing recommendations to perform liver function tests in all patients receiving agomelatine at treatment initiation and during treatment have been extended to include testing when the dose is increased.

Prescribers should now perform liver function tests in all patients receiving agomelatine:

  • At initiation of treatment
  • At weeks 3, 6, 12, 24 and periodically thereafter
  • When increasing the dose of agomelatine (at the same time intervals as above)
  • Whenever clinically indicated

In addition:

  • Any patient who develops increased serum transaminases should have their liver function tests repeated within 48 hours
  • Agomelatine should be immediately discontinued if an increase in serum transaminases exceeds three times the upper limit of normal, or if patients present with symptoms or signs of potential liver injury
  • Patients should be informed of the symptoms of potential liver injury and advised to stop taking agomelatine immediately and seek urgent medical advice if these symptoms appear
  • The balance of benefits and risks should be carefully considered before initiating treatment in patients with elevated levels of transaminases pre-treatment or risk factors for hepatic injury
  • Prescribers are reminded that agomelatine is contraindicated in patients with hepatic impairment, ie cirrhosis or active liver disease.

View Valdoxan drug record

Further information: Servier

Follow MIMS on Twitter

Want news like this straight to your inbox?
Sign up for our bulletins

Have you registered with us yet?

Register now to enjoy more articles and free email bulletins

Already registered?
Sign in

Register or Subscribe to MIMS

GPs can get MIMS print & online and GPonline for free when they register online – take 2 minutes, and make sure you get your free MIMS access! If you're not a GP, you can subscribe to MIMS for full access.

Register or subscribe

MIMS Dermatology

Read the latest issue online exclusively on MIMS Learning.

Read MIMS Dermatology

MIMS Adviser

Especially created for prescribing influencers.

Request free copy

Mobile apps

MIMS: access the full drug database and quick-reference tables on the go

MIMS Diagnosis and Management: concise information on signs and symptoms, investigations and diseases