News FAMHP

The company Kela Pharma has indicated that, due to production issues, its Maniprex® 250 mg coated tablets and Maniprex® 500 mg film-coated tablets will be unavailable for an indefinite period once current stocks have been exhausted. The stock of Maniprex® 500 mg has already been exhausted, and Kela Pharma predicts, based on normal circumstances, that the stock of Maniprex® 250 mg will be exhausted by June 2018.

EMA recommends immediate suspension and recall of multiple sclerosis medicine Zinbryta on basis of evidence indicating risk of serious inflammatory brain disorders.

The Royal Decree of 9 January 2018 on biobanks, published in the Belgian Official Gazette on 05.02.2018 in implementation of Article 22 of the Law of 19 December 2008 regarding the procurement and use of human substances destined for human medical applications or for scientific research purposes, enters into force on 01.11.2018.

Following an alert from the United Kingdom's National Health Service (NHS), the European Medicines Agency Pharmacovigilance Risk Assessment Committee (PRAC) analysed reports of incidents linked to the extraction of insulin from prefilled pens and cartridges for reusable pens with the aid of a syringe. This practice can increase the risk of medication error and lead to dysglycaemia. However, until today, only the package leaflets of certain insulins mentioned the possibility of such extraction.

The FAMHP (pharmaco-, materio-, haemo-, bio-) Vigilance Division has recently been informed by pharmacists of medication errors due to confusion between Depakine 300 mg/5 ml syrup and Depakine 300 mg/ml drinkable solution. The FAMHP wishes to draw the attention of health professionals and patients to this risk of confusion.

Market authorisation holders for medicines for human use must follow certain labelling and packaging guidelines. These guidelines are being amended.

During its meeting of January 2018, the Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA) concluded the new reassessment of drip solutions containing hydroxyethyl starch (HES) that began in October 2017. The PRAC recommends suspending their marketing authorisations (MA).

Saccharomyces boulardii-based medicinal products are now contraindicated for seriously ill or immunosuppressed patients due to a risk of fungaemia.