Agomelatine hepatotoxicity warning

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

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