title: Review: UK medicines likely to be affected by the proposed European Medicines Agency's guidelines on phthalates.
abstract: BACKGROUND
  Phthalates are excipients in drug formulations. However, concerns have been raised about the effects of particular phthalates on reproduction and development. As a result the EMA has introduced guidelines for permitted daily exposure (PDE) limits for certain phthalates. Therefore, the objective of this study was to identify UK licensed medicines that contain the relevant phthalates and determine if they fall within the recommended PDE.
  
  
  METHODS
  The eMC was used to identify which UK licensed medicines contain the phthalates in question. Companies were then contacted for information on the phthalate levels in their products, which was compared with the PDE recommended by the EMA.
  
  
  RESULTS
  The eMC search revealed that 54 medicines contained at least one of the phthalates in question. However, only six medicines, namely Asacol 800 mg MR (Warner Chilcott UK), Epilim 200 Gastro-resistant tablets (Sanofi), Prednisolone 2.5 mg and 5 mg Gastro-resistant tablets (Actavis UK), Vivotif (Crucell Italy S.r.l), and Zentiva 200 mg Gastro-resistant tablets (Winthrop Pharmaceuticals UK), were identified as containing levels that exceeded the recommended PDE.
  
  
  CONCLUSIONS
  These findings indicate that very few UK licensed medicines will be affected by the proposed EMA guidelines. For those medicines identified as exceeding recommendations, these findings highlight the need to instigate a risk-benefit review.
authors.affiliation: Enucleo Limited, Farnham, Surrey, UK. lisa@enucleo.co.uk.
authors.forename: Lisa
authors.initials: L
authors.lastname: Jamieson
authors.affiliation: Tillotts Pharma UK Ltd., Larbourne Suite, 8 The Stables, Wellingore Hall, Wellingore, Lincoln, LN5 0HX, UK. wmccully@tillotts.com.
authors.forename: William
authors.initials: W
authors.lastname: McCully
mesh_terms: D003993:Dibutyl Phthalate / Q000592:standards*; D004304:Dosage Forms / Q000592:standards*; D005079:Excipients / Q000592:standards*; D019983:Guideline Adherence; D006801:Humans; D010795:Phthalic Acids / Q000592:standards*; D011145:Polyvinyls / Q000592:standards*; D006113:United Kingdom
chemical_list: D004304:Dosage Forms; D005079:Excipients; D010795:Phthalic Acids; D011145:Polyvinyls; D003993:Dibutyl Phthalate; C036125:polyvinylacetate phthalate polymer; C007379:diethyl phthalate