PMID- 31533915
OWN - NLM
STAT- MEDLINE
DCOM- 20200506
LR  - 20200506
IS  - 1468-2044 (Electronic)
IS  - 0003-9888 (Linking)
VI  - 105
IP  - 2
DP  - 2020 Feb
TI  - Medical devices that look like medicines: safety and regulatory concerns for 
      children in Europe.
PG  - 147-154
LID - 10.1136/archdischild-2018-316391 [doi]
AB  - INTRODUCTION: Medical devices (MedDevs) and medicines are assessed (and 
      monitored) differently before and after launch. There are products for repeated 
      oral ingestion that are marketed in the European Union as MedDevs. OBJECTIVES AND 
      METHODS: To illustrate the consequences of these differences in assessment, we 
      compared the leaflet information of three MedDevs with the standards for 
      medicines and with published evidence at launch. As examples, gelatin tannate 
      (GT), its combination with tyndalised probiotics (TP) (GTTP) for diarrhoea and a 
      gel containing hyaluronic acid (HA)/chondroitin sulfate (CS)/poloxamer (Pol407) 
      (HACSPol) for gastro-oesophageal reflux disease were examined. RESULTS: Applying 
      standards for medicines, product composition is insufficiently defined in the 
      MedDev leaflet (eg, plant origin, polymerisation grade, dose and ratio of the 
      relevant constituents). As no age limit is mentioned in the leaflets, all 3 
      products allow use in children from birth onwards, although published clinical 
      documentation in children was poor (GT) or lacking (GTTP and HACSPol). MedDev 
      leaflets do not mention adverse events (AEs), while literature search suggests 
      safety concerns such as tannic acid (TA) cytotoxicity, potentially more 
      diarrhoea/AEs with TP, use of doses higher than established safe (TA and HA) and 
      lack of chronic toxicity studies for oral Pol407. None refers to interactions 
      with medicines, although some ingredients may affect medicine absorption. 
      CONCLUSION: Although these MedDevs require repeated oral intake as do medicines, 
      their assessment and monitoring differ significantly from the standards for 
      medicines. Compared with medicines, MedDevs for repeated oral use are poorly 
      labelled and rely on very limited clinical information at market release.
CI  - (c) Author(s) (or their employer(s)) 2020. No commercial re-use. See rights and 
      permissions. Published by BMJ.
FAU - Huijghebaert, Suzy
AU  - Huijghebaert S
AD  - Pharmacist, Brussels, Belgium.
FAU - De Bruyne, Pauline
AU  - De Bruyne P
AD  - Department of Paediatric Gastroenteroloy, Ghent University Hospital - Ghent 
      University, Gent, Belgium.
AD  - Department of Paediatric Gastroenterology, Erasmus MC, Rotterdam, The 
      Netherlands.
FAU - Allegaert, Karel
AU  - Allegaert K
AD  - Department of Paediatrics, Division of Neonatology, Sophia Children's Hospital, 
      Erasmus MC, Rotterdam, The Netherlands.
AD  - Department of Development and Regeneration, KU Leuven, Leuven, Belgium.
FAU - Vande Velde, Saskia
AU  - Vande Velde S
AD  - Department of Paediatric Gastroenteroloy, Ghent University Hospital - Ghent 
      University, Gent, Belgium.
FAU - De Bruyne, Ruth
AU  - De Bruyne R
AD  - Department of Paediatric Gastroenteroloy, Ghent University Hospital - Ghent 
      University, Gent, Belgium.
FAU - Van Biervliet, Stephanie
AU  - Van Biervliet S
AD  - Department of Paediatric Gastroenteroloy, Ghent University Hospital - Ghent 
      University, Gent, Belgium.
FAU - Van Winckel, Myriam
AU  - Van Winckel M
AD  - Department of Paediatric Gastroenteroloy, Ghent University Hospital - Ghent 
      University, Gent, Belgium myriam.vanwinckel@ugent.be.
LA  - eng
PT  - Comparative Study
PT  - Journal Article
DEP - 20190918
PL  - England
TA  - Arch Dis Child
JT  - Archives of disease in childhood
JID - 0372434
RN  - 0 (Pharmaceutical Preparations)
SB  - IM
MH  - Administration, Oral
MH  - Child
MH  - *Equipment and Supplies/adverse effects
MH  - Europe
MH  - Humans
MH  - *Medical Device Legislation
MH  - Pharmaceutical Preparations
MH  - Product Labeling
OTO - NOTNLM
OT  - Medical Devices legislation
OT  - clinical pharmacology
OT  - paediatrics
COIS- Competing interests: None declared.
EDAT- 2019/09/20 06:00
MHDA- 2020/05/07 06:00
CRDT- 2019/09/20 06:00
PHST- 2018/10/14 00:00 [received]
PHST- 2019/07/28 00:00 [revised]
PHST- 2019/08/23 00:00 [accepted]
PHST- 2019/09/20 06:00 [pubmed]
PHST- 2020/05/07 06:00 [medline]
PHST- 2019/09/20 06:00 [entrez]
AID - archdischild-2018-316391 [pii]
AID - 10.1136/archdischild-2018-316391 [doi]
PST - ppublish
SO  - Arch Dis Child. 2020 Feb;105(2):147-154. doi: 10.1136/archdischild-2018-316391. 
      Epub 2019 Sep 18.