Assessing the information in the Summaries of Product Characteristics for the use of medicines in pregnancy and lactation

Abstract

AIMSTo assess the completeness and applicability of information for the use of medicines in pregnancy and lactation contained in European Summaries of Product Characteristics (SmPCs). METHODSSmPCs available on the EMA website in April 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. SmPCs were classified as containing 'conclusive' or 'ambiguous' information depending on whether (or not) they provided clear instructions regarding medicine use in pregnancy and lactation. RESULTSOf the 534 SmPCs, 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 SmPCs, respectively, and medicine use was restricted in over 90% SmPCs for both pregnancy and breastfeeding, despite no information supporting these restrictions being reported. The time elapsed since a SmPCs first approval was not associated with an increase in information quality. CONCLUSIONSImportant information deficits on the use of medicines during pregnancy and breastfeeding were found in European SmPCs. WHAT IS ALREADY KNOWN ABOUT THIS SUBJECT• Reliable information regarding the use of many medicines during pregnancy is critical for researchers and healthcare professionals who work in antenatal care, but this information has been found to differ across different sources.• The Summary of Product Characteristics (SmPCs) is the European official medicines information source for professionals and contains a specific section to include information on medicines use during pregnancy and lactation to guide decision making.• Future electronic versions of SmPCs to be included in clinical decision support systems will require intelligible and logical electronic information. WHAT THIS STUDY ADDS• Important information deficits on the use of medicines during pregnancy and lactation were found in European SmPCs, and the time elapsed since a SmPC's marketing authorization was not associated with an increase in information quality.• Post-authorization data on the exposure to medicinal products during pregnancy and lactation should be actively collected and included in official information sources to keep them updated and to assist decision making.

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“…Nesse sentido, as precauções não são, necessariamente, fruto de evidências, mas sim de medida defensiva do fabricante quando as informações de segurança não estão disponíveis 13 , ou estão disponíveis, mas são controversas. É possível que as agências reguladoras de medicamentos, por sua vez, não estejam contribuindo satisfatoriamente para a minimização das informações precárias sobre esse tópico, como destacado por Arguello et al 14 . Embora as bulas sejam produzidas pelas empresas farmacêuticas, elas são, em última instância, aprovadas pelas agências reguladoras, tornando-se uma fonte de informação oficial sobre medicamentos 14 .…”

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Contraindications to Breastfeeding - Current Issues at the Border Between Myth and Reality

“…Milk is produced following several stages that begin before the baby is born. Milk production is regulated by Th e European summary of product characteristics uses the following phrase "the use of 90% of medicines is restricted both during pregnancy and during breast-feeding, despite the lack of information to support such indications" to avoid possible litigation 16 . Th is phrase can lead to cessation of breastfeeding in mothers who use medications, sometimes well-founded, other times only because of excessive caution.…”

Use of paracetamol during pregnancy and child neurological development

“…Among 172 medications approved in the USA between 2000 and 2010, 73% had no data on the safety in pregnancy and 98% had insufficient data to evaluate teratogenic risk . In the European Union (EU), 68% of marketed product via the EU centralized procedure, and published on the European Medicines Agency (EMA) website, indicate in their Summary of Product Characteristics that there is no clinical experience during pregnancy . Pregnant females are typically excluded from clinical trials, thus, there is often an absence of evidence‐based information in this group of patients at the time of marketing authorization.…”

“…2 In the European Union (EU), 68% of marketed product via the EU centralized procedure, and published on the European Medicines Agency (EMA) website, indicate in their Summary of Product Characteristics that there is no clinical experience during pregnancy. 3 Pregnant females are typically excluded from clinical trials, thus, there is often an absence of evidence-based information in this group of patients at the time of marketing authorization. The EMA recently conducted an analysis of data sources on drug exposure during pregnancy and has noted several issues in obtaining high quality data.…”