US EPA

2918738 

Journal Article 

Review 

Review: UK medicines likely to be affected by the proposed European Medicines Agency's guidelines on phthalates 

Jamieson, L; Mccully, W 

2015 

Yes 

BioMed Central Ltd. 

LONDON 

16 

1 

17 

English 

26070463 

10.1186/s40360-015-0018-9 

WOS:000356342300001 

https://search.proquest.com/docview/1689312506?accountid=171501
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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. 

Environmental exposure; Phthalic acids; Dibutyl Phthalate (DBP); Diethyl Phthalate (DEP); Polyvinylacetate Phthalate (PVAP); Excipients; Phthalate