Identification of Pregnancy Adverse Drug Reactions in Pharmacovigilance Reporting Systems: A Novel Algorithm Developed in EudraVigilance

Author:

Zaccaria CosimoORCID,Piccolo LorisORCID,Gordillo-Marañón MaríaORCID,Touraille GillesORCID,de Vries CorinneORCID

Publisher

Springer Science and Business Media LLC

Reference23 articles.

1. Screening for adverse reactions in EudraVigilance [Internet]. European Medicines Agency. 2016. https://www.ema.europa.eu/en/documents/other/screening-adverse-reactions-eudravigilance_en.pdf. Accessed 4 June 2024.

2. Fornasier G, Francescon S, Leone R, Baldo P. An historical overview over pharmacovigilance. Int J Clin Pharm [Internet]. 2018;40:744–7. https://doi.org/10.1007/s11096-018-0657-1.

3. Topic: ConcePTION—Continuum of Evidence from Pregnancy Exposures, Reproductive Toxicology and Breastfeeding to Improve Outcomes Now [Internet]. https://www.imi.europa.eu/sites/default/files/uploads/documents/news-events/newsletters/DraftTopic2017_PregnancyBreastfeeding.pdf. Accessed 4 June 2024.

4. Sessa M, Mascolo A, Callréus T, Capuano A, Rossi F, Andersen M. Direct-acting oral anticoagulants (DOACs) in pregnancy: new insight from VigiBase®. Sci Rep [Internet]. 2019;9:7236.

5. Mitchell AA. Systematic identification of drugs that cause birth defects–a new opportunity. N Engl J Med. 2003;349:2556–9.

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