抄録
Introduction: Some medical devices (MDs) claim enteral barrier mechanisms as if it were medicinal drugs. MDs enter the EU market for direct dispensing as OTC products, through free movement of goods via CE-labelling, and bypass regulatory medicinal approval and control.
Objectives and Methods: To analyse the regulatory quality of package inserts of 3 gastrointestinal products for paediatric use at time of entering EU. For diarrhea: Tasectan;/Gelenterum (gelatin tannate, GT) in EU and Tasectan/Gelenterum (GT+tyndalized heat-killed probiotics; GTTP) in IT+online. For GORD: Ziverel; Esoxx; (hyaluronic acid, chondroitinsulphate, poloxamer 407; HACDSPol) in IT,ES,FR, launch in AT,BE,LUX.
Results: Product characteristics are inaccurately defined in the package insert: the tannate is not specified neither G bloom strength, ratio and free fraction of TA (added to 5 mL milk, 3 layers). GTTP powder contains heat-killed bacteria, but units are undisclosed)-. For HACDPol gel, doses of HA, CS and Pol 407, origin (rooster comb/bacterial) and polymerization grade of HA are missing. All leaflets allow unlimited use in children from birth onwards: GT and GTTP for effective relief of diarrhea., HACSPol GORD symptoms. Clinical documentation was poor, even lacking for children with GTTP and HACSPol. For GT, efficacy was claimed based on 'observations' in 2 'cohorts' (ORS+GT vs ORS) for 48hrs. The only placebo-controlled study in adults did not confirm the claim. For GTTP, studies in adults were even not retrieved; for HACSPol, gel or placebo was given add-on to standard-dose PPIs, even in PPI-naive adults: there are no data confirming efficacy as single product, neither in comparison to PPI. Safety: MD leaflets mention no known or no observed side effects. Yet, literature calls for attention (carcinogen, diarrhea, beyond amounts of approved food supplement, nephrotoxicity, drug-drug interactions, impaired wound healing, CYP450 and P-gp inhibition).
Conclusion: EU regulation requires only national notification of MDs. This results in the marketing of poorly investigated and poorly labelled oral MDs claiming on barrier effects. They do not guarantee effective and safe 'medical' treatment of children.
