ArticleBritish journal of clinical pharmacology2015
Assessing the information in the Summaries of Product Characteristics for the use of medicines in pregnancy and lactation.
Article in British journal of clinical pharmacology, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 21 papers, 1 of them a synthesis that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
21 citing papers in PubMed, 1 synthesis or guideline pooled it, 37 citations in OpenAlex.
- Pooled it
- Article
- Timely updates to the Summary of Product Characteristics: supporting evidence-based prescribing in pregnancy.Frontiers in global women's health · 2026Article
- Beta-blockers and breastfeeding: a real-life prospective study.European journal of clinical pharmacology · 2024Article
- EMA perspective on the value of model-informed drug development for labeling recommendations regarding medicine use during pregnancy and breastfeeding.CPT: pharmacometrics & systems pharmacology · 2024Article
- Investigating Variations in Medicine Approvals for Attention-Deficit/Hyperactivity Disorder: A Cross-Country Document Analysis Comparing Drug Labeling.Journal of attention disorders · 2024Article
- Authorized or Off-Label Use? A Structured Analysis of Summaries of Product Characteristics with Regard to Authorization in Pediatrics.Pharmaceutical medicine · 2024Article
- Healthcare professionals' information need related to antiseizure medication use in breastfeeding patients with epilepsy. Retrospective analysis of enquiries to Norwegian medicines information and pharmacovigilance centers.Epilepsy & behavior reports · 2023Article
- Observational
- The Quality and Reliability of Information in the Summaries of Product Characteristics.International journal of environmental research and public health · 2022Review
- Dutch trends in the use of potentially harmful medication during pregnancy.British journal of clinical pharmacology · 2020Article
- Article
- An inventory of medicinal products causing skin rash: Clinical and regulatory lessons.Experimental and therapeutic medicine · 2019Article
- Do drugs used in obstetric anesthesia interfere with early breastfeeding? What determines drug safety in lactation? Part 1.Developmental period medicine · 2019Article
- Evaluation of Information in Summaries of Product Characteristics (SmPCs) on the Use of a Medicine in Patients With Hepatic Impairment.Frontiers in pharmacology · 2019Article
- Analysis of questions about use of drugs in breastfeeding to Norwegian drug information centres.International breastfeeding journal · 2018Article
- Controversies in Breastfeeding.Frontiers in pediatrics · 2018Review
- Comparing cytochrome P450 pharmacogenetic information available on United States drug labels and European Union Summaries of Product Characteristics.The pharmacogenomics journal · 2017Article
- Ontology-based systematical representation and drug class effect analysis of package insert-reported adverse events associated with cardiovascular drugs used in China.Scientific reports · 2017Article
- COVID-19 and breastfeeding: can SARS-CoV-2 be spread through lactation?Discoveries (Craiova, Romania)Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
3 authors at 1 institution in 1 country.
Funding
No grant is acknowledged in the PubMed record.
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.
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What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.