Symbioflor E. coli - drops recommended only for irritable bowel syndrome and for adults

Safety warnings | messages in brief | 29/06/2017

Measures at EU level

A Europe-wide review of Symbioflor E. coli drops by the European Medicines Agency (EMA) has shown that the drops can continue to be used for the treatment of irritable bowel syndrome (IBS) in adults. However, the medicinal product should no longer be used for the treatment of so-called functional gastrointestinal disorders, as these can have a variety of causes and therefore also require other treatment concepts.

The Escherichia coli bacteria contained in Symbioflor E. coli - drops are intended to stimulate the growth of beneficial organisms ("flora") in the intestine, which is why the product is called a probiotic. It was first approved in Germany as early as 1950, and later also in Austria and Hungary.

This decision was reached by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) following a re-examination of data on the efficacy and safety of Symbioflor E. coli drops. These data included clinical studies, scientific publications, post-marketing experience and information provided by the marketing authorization holder. In addition, a specially established expert group was involved in the evaluation of Symbioflor E. coli Drops. However, the review of the data presented did not provide any new evidence of efficacy beyond that provided by the marketing authorization. The risk associated with the use of this drug was considered to be low.

A randomized study of approximately 300 adults indicated efficacy of Symbioflor E. coli drops in adults with IBS. However, the study showed some weaknesses. Furthermore, efficacy has not yet been shown in children with IBS.

Since the data presented were not considered sufficiently robust to make a final decision regarding the strength of efficacy of Symbioflor E. coli - Drops, nor whether the drops work in each specific type of IBS, the company was asked to submit an appropriately powered study demonstrating efficacy and safety in patients with different manifestations and types of IBS (e.g., those types in which diarrhea (diarrhea) or constipation (constipation) are prominent). The submission of the study results to the national authorities is to be considered a condition for the continued maintenance of the marketing authorization of Symbioflor E. coli - drops.

As the marketing authorization holder of Symbioflor E. coli - Drops did not submit any data that could demonstrate a meaningful use in the indication "functional gastrointestinal disorders", which was also approved so far, he agreed to delete this indication in the future.

The CHMP will subsequently forward this recommendation to the European Commission in order to make the decision legally binding throughout the EU.

Situation in Austria

The following medicinal products are approved in Austria:

Symbioflor E. coli - drops.

BASG has received one adverse reaction report from Austria regarding Symbioflor E. coli - Drops.

Recommendations for patients:

Symbioflor E. coli drops may continue to be used for the treatment of irritable bowel syndrome. The information in the package leaflet should be observed.

If you have stomach or intestinal problems, please discuss them with your doctor or pharmacist. Symbioflor E. coli - drops should not be used for other intestinal problems except irritable bowel syndrome.

Symbioflor E. coli - drops are available without a prescription. If the symptoms of irritable bowel syndrome do not improve or even worsen during treatment with these drops, please talk to your doctor or pharmacist.