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Assessing the information in the Summaries of Product Characteristics for the use of medicines in pregnancy and lactation
Author(s) -
Arguello Blanca,
Salgado Teresa M.,
FernandezLlimos Fernando
Publication year - 2015
Publication title -
british journal of clinical pharmacology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.216
H-Index - 146
eISSN - 1365-2125
pISSN - 0306-5251
DOI - 10.1111/bcp.12515
Subject(s) - lactation , pregnancy , product (mathematics) , medicine , obstetrics , computer science , biology , mathematics , genetics , geometry
Aims To assess the completeness and applicability of information for the use of medicines in pregnancy and lactation contained in E uropean Summaries of Product Characteristics ( SmPC s). Methods SmPC s available on the EMA website in A pril 2011 were retrieved, and information on the use of medicines during pregnancy and lactation was analyzed. A form was designed to extract information regarding drug concentrations crossing the placenta, excretion of the drug in milk, the existence of pre‐clinical and clinical studies and clinical experience describing the use of the medicine in pregnancy and lactation, medicine effects on human fertility, medicines use in women of child‐bearing potential and specific recommendations for use during pregnancy and breastfeeding. SmPC s were classified as containing ‘conclusive’ or ‘ambiguous’ information depending on whether (or not) they provided clear instructions regarding medicine use in pregnancy and lactation. Results Of the 534 SmPC s, 89.3% did not mention whether the drug crossed the placenta, 67.6% indicated that there was no clinical experience during pregnancy and in 61.4% it was unknown whether the medicine was excreted in human milk. Recommendations for medicine use during pregnancy and breastfeeding were ambiguous in 57.0% and 16.5% of the SmPC s, respectively, and medicine use was restricted in over 90% SmPC s for both pregnancy and breastfeeding, despite no information supporting these restrictions being reported. The time elapsed since a SmPC s first approval was not associated with an increase in information quality. Conclusions Important information deficits on the use of medicines during pregnancy and breastfeeding were found in E uropean SmPC s.