Depression drug contraindicated in the over-75s: PRAC
by Pharmacy Life - Published on 14 September 2014
The
Pharmacovigilance Risk Assessment Committee (PRAC) has concluded its regular benefit-risk assessment (known as a periodic safety update report or PSUR) of
Valdoxan/Thymanax (agomelatine): two identical medicines used to treat major depression in adults.
As part of this assessment, the PRAC looked at cumulative data on
severe side effects on the liver with Valdoxan/Thymanax and recommended further measures to minimise this risk, particularly in vulnerable populations.
The PRAC recommended that
the warnings in the product information regarding liver injury be strengthened to further clarify that liver function tests should be performed before and regularly during treatment. As patients aged 75 years and above may be at an increased risk of severe side effects on the liver, and beneficial effects have not been documented in these patients, the Committee
recommended that Valdoxan/Thymanax should now be contraindicated in patients aged 75 and above. The Committee further recommended that a letter be sent to healthcare professionals to inform them of these changes.
The PRAC recommendations will now be forwarded to the Committee for Medicinal Products for Human Use (CHMP) which will issue the Agency’s final opinion with clear guidance to patients and healthcare professionals at its next meeting (22-25 September 2014).