OBJECTIVE: To provide the first update on drug safety profiles and adverse drug reactions (ADRs) associated with fetal disorders from the Swiss national ADR database. METHODS: We conducted a retrospective study using data from 202 pharmacovigilance reports on drug-associated fetal disorders from the Swiss national ADR database from 1990 to 2009. Evaluated aspects included administrative information on the report, drug exposure, and disorders. RESULTS: The ADR reporting frequency on the topic of fetal disorders has increased during the last 20 years, from only 1 report in 1991 to a maximum of 31 reports in 2008. Nervous system drugs were the most frequently reported drug group (40.2%) above all antidepressants and antiepileptics. The highest level of overall drug intake could be observed for the 1st trimester (85.4%), especially for the first 6 weeks of pregnancy. The most frequently reported types of fetal disorders were malformations (68.8%), especially those of the musculoskeletal and circulatory systems. A positive association was discovered between antiepileptics and malformations in general and in particular of the circulatory system and the eye, ear, face, and neck. CONCLUSIONS: The results suggest that the nervous system drug group bears an especially high risk for malformations. The most commonly identified drug exposures can help focus pharmacoepidemiologic efforts in drug-induced birth defects.
OBJECTIVE: To provide the first update on drug safety profiles and adverse drug reactions (ADRs) associated with fetal disorders from the Swiss national ADR database. METHODS: We conducted a retrospective study using data from 202 pharmacovigilance reports on drug-associated fetal disorders from the Swiss national ADR database from 1990 to 2009. Evaluated aspects included administrative information on the report, drug exposure, and disorders. RESULTS: The ADR reporting frequency on the topic of fetal disorders has increased during the last 20 years, from only 1 report in 1991 to a maximum of 31 reports in 2008. Nervous system drugs were the most frequently reported drug group (40.2%) above all antidepressants and antiepileptics. The highest level of overall drug intake could be observed for the 1st trimester (85.4%), especially for the first 6 weeks of pregnancy. The most frequently reported types of fetal disorders were malformations (68.8%), especially those of the musculoskeletal and circulatory systems. A positive association was discovered between antiepileptics and malformations in general and in particular of the circulatory system and the eye, ear, face, and neck. CONCLUSIONS: The results suggest that the nervous system drug group bears an especially high risk for malformations. The most commonly identified drug exposures can help focus pharmacoepidemiologic efforts in drug-induced birth defects.
Authors: Yara D Fragoso; Tarso Adoni; Soniza V Alves-Leon; Nério D Azambuja; Amilton A Barreira; Joseph B B Brooks; Denise S D Carneiro; Margarete J Carvalho; Rinaldo Claudino; Elizabeth R Comini-Frota; Renan B Domingues; Alessandro Finkelzstejn; Paulo D Gama; Maria C B Giacomo; Sidney Gomes; Marcus V M Goncalves; Anderson K Grzesiuk; Damacio R Kaimen-Maciel; Maria F Mendes; Nivea M O Morales; Rogério R Morales; Andre Muniz; Regina M Papais-Alvarenga; Monica K F Parolin; Sonia B F Ribeiro; Heloisa H Ruocco; Fabio Siquineli; Elza D Tosta Journal: CNS Drugs Date: 2013-11 Impact factor: 5.749
Authors: Alfredo Dias de Oliveira-Filho; Antonio Emanuel Soares Vieira; Roberta Cruz da Silva; Sabrina Joany Felizardo Neves; Thiago Antonio Barros Gama; Ryane Vieira Lima; Wlisses Ramon Oliveira; Júlia Maria de Gonçalves Dias Journal: Saudi Pharm J Date: 2017-02-02 Impact factor: 4.330