News FAMHP

Sanofi Belgium has decided to stop marketing Depakine 300 mg/5 ml syrup as of 28 April 28 2025. However, Depakine's other oral liquid formulation, the 300 mg/ml oral solution, will remain available in Belgium. As this drink is more concentrated than the syrup and dosed with a different device, patients, healthcare professionals and parents need to be informed and prepared to avoid potential medication errors.

Today sees the start of the ninth edition of #MedSafetyWeek, a global campaign running from 4 to 10 November 2024, bringing together 107 organisations from 94 countries. This year's theme is the importance of using medicines correctly in order to prevent adverse effects and to report them if they occur.

The Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA) is going to evaluate data relating to suicidal ideation and behaviour.

Since 1 February 2023, a withdrawal programme can be provided for outpatients taking benzodiazepines or Z-drugs. This programme is based on the magistral preparation of capsules following a doctor's prescription. The project, which was initially due to run for one year, has been extended until 31 December 2024.

During its July 2024 meeting, the Pharmacovigilance Risk Assessment Committee of the European Medicines Agency issued new recommendations for GLP-1 receptor agonists and agreed a direct healthcare professional communication for glatiramer acetate containing products.

During its June 2024 meeting, the Pharmacovigilance Risk Assessment Committee of the European Medicines Agency started a review of the painkiller metamizole and identified a risk of secondary malignancies of T-cell origin with CAR T- cell medicines.

Some medicines may cause (severe) skin reactions if the skin is exposed to UV light (from the sun or from an artificial source). The FAMHP is drawing attention to the different types of light sensitivity, which common medicines present an increased risk, the reports it has received, and a number of precautionary measures.

During its April 2024 meeting, the Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA) has concluded that there is no available evidence supporting a link between GLP-1 receptor agonists and suicidal thoughts and thoughts of self-harm and advice to CHMP on new Rybelsus tablets.

During the March 2024 meeting, the Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA) concluded that there is no link between postmenopausal bleeding and mRNA COVID-19 vaccines.

During its January 2024 meeting, the Pharmacovigilance Risk Assessment Committee of the European Medicines Agency recommends precautionary measures regarding the potential risk of neurodevelopmental disorders in children born to men treated with valproate medicines.