Outcome of periodic safety update report assessment leads to recommendation to restrict use of a medicine
The European Medicines Agency’s Pharmacovigilance Risk Assessment Committee (PRAC) has recommended restrictions in the use of Protelos/Osseor (strontium ranelate) based on the outcome of a routine benefit-risk assessment of the medicine, known as a periodic safety update report or PSUR. Pending confirmation from the Committee for Medicinal Products for Human Use (CHMP), this will be the first time that a PSUR assessment leads directly to a recommendation to restrict the use of a medicine.
This new robust mechanism to assess the benefits and risks of authorised medicines has been introduced by the new pharmacovigilance legislation. It makes the safety-monitoring of medicines even more swift and efficient, delivering regulatory action to ensure the safe and effective use of medicines for the benefit of patients.
PSURs are reports providing an evaluation of the benefit-risk balance of a medicine. They are submitted by marketing-authorisation holders at defined time points following a medicine’s authorisation. During PSURs assessment, the PRAC evaluates any new risks identified for a medicine, to assess whether its balance of benefits and risks has changed. The Committee can then decide whether further investigations need to be carried out or they can recommend action to protect the public from the risks identified.
A link to more information on this review is available in a question-and-answer document.
PRAC recommends suspension of tetrazepam-containing medicines
At the meeting, the PRAC also recommended the suspension of tetrazepam-containing medicines following a review initiated at the request of France in January 2013. This type of procedure is triggered when a Member State or the European Commission considers that urgent action across the European Union (EU) is necessary because of a safety issue with a medicine. As part of the procedure, the PRAC invited stakeholders such as healthcare professionals, patients’ organisations and the general public to submit data relevant to the procedure so that they could be considered during the assessment of the medicines. This is a new tool which allows the Committee to actively engage stakeholders in the evaluation process, and helps to ensure that all relevant data, information and knowledge are fed into the assessment.
As tetrazepam-containing medicines are all authorised nationally, the PRAC recommendation will now be considered by Co-ordination Group for Mutual Recognition and Decentralised Procedures – Human (CMDh), which will adopt a final scientific opinion. The CMDh is a regulatory body that represents national medicines regulatory authorities of the EU Member States. The final opinion is expected to be adopted at the CMDh meeting in April 2013.
The review of Diane 35 and its generics is on track. The PRAC continued its assessment of all available data on Diane 35 and its generics, in consultation with cardiologists and other experts from across the EU, and a recommendation from the Committee is due in May 2013. The review of third- and fourth-generation combined hormonal contraceptives continues. An update from the PRAC is expected in July 2013.
Following their nomination in March 2013, Committee members representing healthcare professionals and patients participated in the PRAC for the first time. The appointment was made by the European Commission following a public call for expressions of interest and a consultation of the European Parliament. Their role is to bring the views, concerns and experiences of patients and doctors to the PRAC’s scientific considerations.