Background:

Saccharomyces boulardii is a live yeast used as a probiotic. Previously, Saccharomyces boulardii -containing products have been contraindicated in patients with central venous catheter (CVC) due to the risk of fungaemia.

In November 2017, the European Medicines Agency (EMA) had concluded that the risk of using Saccharomyces boulardii- containing products in critically ill or immunocompromised patients outweighs the potential benefit due to the risk of fungaemia¹. According to the latest Periodic Safety Update Report (PSUR) of Saccharomyces boulardii, a total of 61 cases of fungaemia have been reported cumulatively, while the EudraVigilance database revealed a total of ten (10) fatal cases of fungaemia/fungal infection and sepsis associated with administration of S. boulardii containing products. Following this, it is in the opinion of EMA that an update of the product information of Saccharomyces boulardii containing products is warranted.

NPRA has conducted a safety review on the risk of fungaemia with the use Saccharomyces boulardii containing products and concluded that the product packaging information must be updated to include information on this risk.

Adverse Drug Reaction Reports:

To date, no ADR report associated with the use of Saccharomyces boulardii -containing products has been received by NPRA².

Advice for Healthcare Professionals:

• There have been very rare cases of fungaemia after consumption of Saccharomyces boulardii -containing products reported mostly in patients with central venous catheter, critically ill or immunocompromised patients, most often resulting in pyrexia. In most cases, the outcome of the patient was satisfactory after the cessation of treatment by Saccharomyces boulardii, administration of antifungal treatment and removal of the catheter, if necessary. However, in some critically ill patients, the outcome was fatal.
• Advise patients to avoid taking Saccharomyces boulardii -containing products if they are immunocompromised or have central venous catheter.
• Please report any adverse drug reactions suspected to be associated to Saccharomyces boulardii use to NPRA.

A directive [Ruj. Kami: (23) dlm. BPFK/PPP/07/25 Jld. 2] has been issued by NPRA for updates to the local product packaging insert and consumer medication information leaflet (Risalah Maklumat Ubat untuk Pengguna) related to this safety issue. Please refer to the directive for more information.

References:

1. European Medicines Agency (2018). Saccharomyces boulardii - CMDh Scientific conclusions and grounds for the variation to the terms of the Marketing Authorisation(s).
2. The Malaysian Adverse Drug Reaction Database, NPRA [Accessed: August 2018].

DISCLAIMER

This publication is aimed at health professionals. The information is meant to provide updates on medication safety issues, and not as a substitute for clinical judgement. While reasonable care has been taken to verify the accuracy of the information at the time of publication, the NPRA shall not be held liable for any loss whatsoever arising from the use of or reliance on this publication.