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https://www.arca.fiocruz.br/handle/icict/22773
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ArtigoDireito Autoral
Acesso restrito
Data de embargo
2030-01-01
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- IOC - Artigos de Periódicos [12482]
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SURVEILLANCE OF ADVERSE FETAL EFFECTS OF MEDICATIONS (SAFE-MED): FINDINGS FROM THE INTERNATIONAL CLEARINGHOUSE OF BIRTH DEFECTS SURVEILLANCE AND RESEARCH
Medicação
Anormalidades Congênitas
Cuidado Pré-Concepcional
Vigilância pós-comercialização
teratogene
Drug
Medication
Birth defect
Preconception
Post-marketing surveillance
Autor(es)
Afiliação
Centre of the International Clearinghouse for Birth Defects Surveillance and Research. Rome, Italy.
University of Utah. School of Medicine. Division of Medical Genetics. Department of Pediatrics. Salt Lake Ciity, Utah, USA.
REgistre des Malformations En Rhône-Alpes. Faculté de Médecine Laennec. Lyon, France.
CEMIC, Buenos Aires, Argentina / Fundação Oswaldo Cruz. ECLAMC. Rio de Janeiro, RJ, Brasil.
University of Groningen. University Medical Centre Groningen. EUROCAT Northern Netherlands. Department of Genetics. The Netherlands.
ISMAC Registry, Genetica Medica. ARNAS Garibaldi Nesima. Catania, Italy.
Bologna University. Institute of Neonatology and Preventive Pediatric Health Care. Bologna, Italy.
Epidemiological Research Unit on Perinatal and Women’s Health. Villejuif, France.
CEMIC, Buenos Aires, Argentina / Fundação Oswaldo Cruz. ECLAMC. Rio de Janeiro, RJ, Brasil.
National Registry of Congenital Anomalies in the Czech Republic. Postgraduate Medical Institute. Medical Genetics. Prague, Czech Republic.
Department of Neonatology. Rabin Medical Center. Beilinson Campus, Petah Tikva, Israel.
Institute of Clinical Physiology. Unit of Epidemiology.CNR Area di Ricerca di San Cataldo, Pisa, Italy.
Campania Birth Defects Register. Division of Medical Genetics. General Hospital “G.Rummo”. Benevento, Italy / Regional Epidemiologic Observatory. Health Council. Benevento, Italy.
National Registry of Congenital Anomalies in the Czech Republic. Department of Medical Genetics. Thomayer’s University Hospital. Prague, Czech Republic.
Kanawaga Children’s Medical Center. Division of Obstetrics and Gynecology. Yokohama City, Japan.
Centre of the International Clearinghouse for Birth Defects Surveillance and Research. Rome, Italy.
University of Utah. School of Medicine. Division of Medical Genetics. Department of Pediatrics. Salt Lake Ciity, Utah, USA.
REgistre des Malformations En Rhône-Alpes. Faculté de Médecine Laennec. Lyon, France.
CEMIC, Buenos Aires, Argentina / Fundação Oswaldo Cruz. ECLAMC. Rio de Janeiro, RJ, Brasil.
University of Groningen. University Medical Centre Groningen. EUROCAT Northern Netherlands. Department of Genetics. The Netherlands.
ISMAC Registry, Genetica Medica. ARNAS Garibaldi Nesima. Catania, Italy.
Bologna University. Institute of Neonatology and Preventive Pediatric Health Care. Bologna, Italy.
Epidemiological Research Unit on Perinatal and Women’s Health. Villejuif, France.
CEMIC, Buenos Aires, Argentina / Fundação Oswaldo Cruz. ECLAMC. Rio de Janeiro, RJ, Brasil.
National Registry of Congenital Anomalies in the Czech Republic. Postgraduate Medical Institute. Medical Genetics. Prague, Czech Republic.
Department of Neonatology. Rabin Medical Center. Beilinson Campus, Petah Tikva, Israel.
Institute of Clinical Physiology. Unit of Epidemiology.CNR Area di Ricerca di San Cataldo, Pisa, Italy.
Campania Birth Defects Register. Division of Medical Genetics. General Hospital “G.Rummo”. Benevento, Italy / Regional Epidemiologic Observatory. Health Council. Benevento, Italy.
National Registry of Congenital Anomalies in the Czech Republic. Department of Medical Genetics. Thomayer’s University Hospital. Prague, Czech Republic.
Kanawaga Children’s Medical Center. Division of Obstetrics and Gynecology. Yokohama City, Japan.
Centre of the International Clearinghouse for Birth Defects Surveillance and Research. Rome, Italy.
Resumo em Inglês
To evaluate whether the routinely collected data in birth defect registries could be used to assess association
between medications and risk for congenital anomalies an “exposed case-only” design was
performed.
Twelve registries provided 18,131 cases exposed to a medication during the first trimester of pregnancy
and with at least one major malformation. Odds ratios for malformations associated with maternal use
of selected medications were computed.
Among seven most commonly used medications very few significant associations with malformations
were identified. Among fourteen potentially teratogenic medications several strong associations were
found, including valproic acid with spina bifida, and insulin (as proxy for diabetes) with several types of
cardiac defects.
Finding known associations provides assurance on the validity of this approach, whereas identifying
new associations provides a signal to be followed by confirmatory studies. Through this activity, international
networks of birth defect registries can contribute with limited resources to post-marketing
surveillance of the teratogenicity of medications.
Palavras-chave
MedicamentosMedicação
Anormalidades Congênitas
Cuidado Pré-Concepcional
Vigilância pós-comercialização
teratogene
Palavras-chave em inglês
TeratogenDrug
Medication
Birth defect
Preconception
Post-marketing surveillance
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