Characteristics and temporal trends of EU teratological safety signals and information dissemination to healthcare professionals in the Netherlands—A contribution of the ConcePTION project
Rattachement africain : nl, gb, Afrique du Sud. Niveau de preuve : code pays fourni par la source.
Le résumé fourni par la source
AIM: Although regulatory responses to safety signals have been studied, pregnancy-specific data and their dissemination to medical professionals remain unclear. This study examined the characteristics and temporal trends of teratological safety signals prompting the European Medicines Agency to implement risk minimization measures. A secondary aim was to investigate how information on these signals, independent of regulatory communication, was disseminated to medical professionals in the Netherlands. METHODS: Teratological safety signals from 2002 to 2022 were retrieved from the European Pharmacovigilance Issues Tracking Tool. For each signal, we recorded the dates of market authorization, first spontaneous report, scientific publication, regulatory decision and dissemination through the Teratology Information Service (TIS) and Dutch professional journals. The source of the signal (spontaneous reports, scientific literature or otherwise) was assessed. Time intervals between events were calculated and visualized. RESULTS: Twenty-four safety signals pertaining to fetal teratogenesis were identified. At the time of regulatory action, medicines had been on the market for a median of 23.9 years (range 3.2-59.3). Cases or studies published in the scientific literature were the origin for most (n = 18, 75%) teratological safety signals. Amendments of the product information was a regulatory action for all signals; eight (33%) also triggered Direct Healthcare Professional Communications. Apart from these regulatory communications, information may have reached healthcare professionals through scientific literature or other channels, sometimes before and sometimes alongside regulatory decisions. CONCLUSION: Teratological safety signals are predominantly scientific literature-driven and often arise decades after marketing. Scientific publications and TIS may provide early guidance, frequently preceding regulatory decisions.
Ce résumé expose les affirmations des auteurs. BNTIC ne l’interprète pas comme une validation indépendante des résultats.
Le contrôle bibliographique ouvert
DOI retrouvé dans Crossref DOI retrouvé ; titre concordant.
- Titre Crossref
- Characteristics and temporal trends of EU teratological safety signals and information dissemination to healthcare professionals in the Netherlands—A contribution of the ConcePTION project
- Date Crossref
- 28/05/2026
- Éditeur
- Wiley
- Type
- journal-article
Ce recoupement confirme des métadonnées liées au DOI. Il ne confirme ni la méthode ni les conclusions de l’étude, et il ne compte pas comme une seconde source scientifique indépendante.
Où se fait cette recherche
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University of Groningen Groningen Research Institute of Pharmacy pays non établi dans la noticeUniversité ou école supérieure
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Medicines Evaluation Board pays non établi dans la noticeUniversité ou école supérieure
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Netherlands Pharmacovigilance Centre Lareb pays non établi dans la noticeStructure de recherche
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Utrecht University Division of Pharmacoepidemiology and Clinical Pharmacology pays non établi dans la noticeUniversité ou école supérieure
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University Medical Center Utrecht pays non établi dans la noticeÉtablissement de santé
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Pharmo Institute pays non établi dans la noticeStructure de recherche
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Newcastle upon Tyne Hospital pays non établi dans la noticeÉtablissement de santé
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Northern Powergrid (United Kingdom) pays non établi dans la noticeEntreprise
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University of KwaZulu-Natal University of KwaZulu-Natal, Afrique du Sud (code pays fourni par la source)Université ou école supérieure
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Pharmacovigilance Centre Lareb 's‐Hertogenbosch The Netherlands pays non établi dans la noticeInstitution
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Department of Clinical Decision Support Health Base Foundation Houten The Netherlands pays non établi dans la noticeÉtablissement de santé
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Department of Clinical Pharmacy University Medical Centre Utrecht Utrecht Netherlands pays non établi dans la noticeUniversité ou école supérieure
Groningen Research Institute of Pharmacy — University of Groningen, Medicines Evaluation Board et Netherlands Pharmacovigilance Centre Lareb, avec 9 autres affiliations. Pays d’affiliation : Afrique du Sud.
Une affiliation ne permet pas de déduire la nationalité d’un auteur.