Flash VIG-news: SACCHAROMYCES BOULARDII (in Belgium: ENTEROL®): risk of fungaemia and contraindication for seriously ill or immunosuppressed patients

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

The risk of fungaemia for patients with a central venous catheter is already recognised. Rare cases of fungaemia have also been reported on a global level amongst hospitalised patients, in critical stage or immunosuppressed (including those without central venous catheters), most often resulting in pyrexia.

Most cases of fungaemia have had a satisfactory outcome once treatment with Saccharomyces boulardii has been stopped, and an anti-fungal treatment has been administered and the catheter removed, if necessary. However, the outcome has proved fatal for some seriously ill patients.

As a result, the summary of product characteristics and the package leaflet for medicinal products containing Saccharomyces boulardii have been updated at European level to include a new warning and contraindication.

As for all medicinal products prepared with living micro-organisms, particular attention must be paid to the handling of the product in the presence of patients treated using a central or peripheral venous catheter, whether with Saccharomyces boulardii or not, in order to avoid all manual contamination and/or the spread of micro-organisms through the air.

In Belgium, only one Saccharomyces boulardii-based medicinal product is marketed (Enterol®); it is indicated for the prevention and treatment of certain diarrhoeas.

The aforementioned warnings and contraindications should also be applied to the numerous food supplements containing Saccharomyces boulardii, as the risk of fungaemia cannot be excluded for such products. As food supplements do not fall within the FAMHP’s remit, this information has also been passed on to the competent authorities in this matter, the FPS Public Health, Safety of the Food Chain and Environment, and the Federal Agency for the Safety of the Food Chain.

Last updated on
26/01/2018