PRAC News – September 2014


PRAC concludes review of Valdoxan and Thymanax (agomelatine)

The 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 lokked at cumulative data on severe side effects on the liver with Valdoxan/thymanax and recommended further measures to minimise this risk, particularly in vulnerable patients.

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 PRAC 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 of 22-25 September 2014.

PRAC - two years of focus on patient safety

The PRAC was established in July 2012. Over its two years the PRAC’s central role in patient safety has been demonstrated.

An important part of the PRAC’s work is the assessment of risk-management plans, submitted by companies before a medicine can be authorised. It also looks at the design and results of post-authorisation safety studies of authorised medicines, which are carried out to obtain further information on their safety. In its first two years the Committee conducted more than 600 reviews of risk management plans and 150 reviews of protocols for post-authorisation safety studies.

Also, the PRAC evaluates periodic safety update reports (PSURs) to re-assess the benefit-risk balance of a medicine throughout its lifecycle on the basis of new data collected. More than 650 PSUR reviews have been carried out by the PRAC since it was established.

In addition, the PRAC is involved in referral procedures, which are started because of concerns over the safety or the benefit-risk balance of a medicine or a class of medicines. Over the last two years, the Committee has started 31 referrals to assess safety concerns of medicines, and issued 23 recommendations on their safe and effective use.

The assessment and management of safety signals is also a key pharmacovigilance function performed by the PRAC. A safety signal is information on a new or known adverse event that is potentially caused by a medicine and that warrants further investigation. In its first two years of operation, 163 signals have been managed by the Committee, the majority resulting in recommendations for changes to product information for patients and healthcare professionals.

Here you may read more about the PRAC recommendations from September 2014.