EMA’s PRAC concludes review of Valdoxan/Thymanax

The European Medicines Agency’s 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 from independent French drugmaker Laboratoires Servier 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 minimize 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.