EMA recommends that Symbioflor 2 can continue to be used for irritable bowel syndrome
Medicine should no longer be used for other disorders of the gut
A review by the European Medicines Agency (EMA) has concluded that Symbioflor 2 and associated names can continue to be used for treatment of irritable bowel syndrome (IBS) in adults. However, the medicine should no longer be used more widely to treat so-called functional gastrointestinal disorders, a group of disorders with a variety of causes that may require different treatment approaches.
Symbioflor 2, which contains Escherichia coli bacteria, has been described as a probiotic, which means that it encourages the growth of beneficial organisms ('flora') in the gut. It was first made available in Germany in the 1950s and subsequently in Austria and Hungary.
In reaching its conclusions, EMA's Committee for Medicinal Products for Human Use (CHMP) reviewed all available evidence on the effectiveness and safety of Symbioflor 2. The data included clinical studies, scientific publications, post-marketing experience, as well as information provided by the company and the views of an expert group formed for evaluating Symbioflor 2. The review did not find any new evidence on the effectiveness of Symbioflor 2 since the product was last approved. Available evidence suggests that the risk of harm from Symbioflor 2 is low.
A randomised study involving around 300 adults suggested that Symbioflor 2 was effective for treating IBS. However, the study had weaknesses. Benefit has not yet been established in children with IBS.
Since the available data are not sufficiently robust for the CHMP to draw conclusions on how well Symbioflor 2 works and whether it is effective for any particular type of IBS, the CHMP has asked the company to carry out a well-designed study on effectiveness and safety among patients with different features of IBS (e.g. those with diarrhoea or with constipation as an important feature). Submission of the study report to national authorities will be a condition for maintaining Symbioflor 2's marketing authorisation.
The company that markets Symbioflor 2 did not submit data to support its use in 'functional gastrointestinal disorders' and agreed to remove this use from the medicine's authorisation.
The CHMP recommendation will now be sent to the European Commission for a legally binding decision that will be valid throughout the EU.