Postlicensure safety surveillance of congenital anomaly and miscarriage among pregnancies exposed to quadrivalent human papillomavirus vaccine.
Hum Vaccin Immunother
; 14(2): 412-419, 2018 02 01.
Article
em En
| MEDLINE
| ID: mdl-29140750
ABSTRACT
Limited safety data are available on inadvertent exposure to quadrivalent human papillomavirus vaccine (4vHPV) during pregnancy. We conducted a descriptive observational postlicensure safety surveillance study in Kaiser Permanente Southern California and Northern California to assess congenital anomaly and miscarriage among pregnancies exposed to 4vHPV. Using electronic medical records, we identified women who received a dose of 4vHPV between August 2006 and March 2008 within 30 days preconception or any time during a possible pregnancy. A broad algorithm was developed using diagnostic and procedure codes and laboratory tests to identify pregnancy, congenital anomalies, and miscarriages. Medical records of all potential congenital anomaly cases and a random sample of 100 potential miscarriage cases were reviewed to confirm pregnancy exposure and diagnosis. Results were reviewed by an independent Safety Review Committee (SRC). Among the population of 189,629 females who received at least one dose of 4vHPV during the study period, 2,678 females were identified as possibly having a 4vHPV-exposed pregnancy. Among 170 potential congenital anomalies identified, 44 (26%) were found to be both 4vHPV-exposed and confirmed congenital anomaly cases. Among the 633 potential miscarriages identified, the records of a random sample of 100 cases were reviewed, and 9 cases (9%) were confirmed as 4vHPV-exposed miscarriages. The SRC noted no safety signal for congenital anomaly or miscarriage associated with 4vHPV exposure during pregnancy. The rate of major congenital anomaly (3.6%) was in the range of background estimates from the literature. There was no apparent pattern of timing of 4vHPV exposure among 4vHPV-exposed miscarriages.
Palavras-chave
Texto completo:
1
Base de dados:
MEDLINE
Assunto principal:
Vigilância de Produtos Comercializados
/
Anormalidades Induzidas por Medicamentos
/
Aborto Espontâneo
/
Infecções por Papillomavirus
/
Vacinas contra Papillomavirus
Tipo de estudo:
Screening_studies
Limite:
Female
/
Humans
/
Newborn
/
Pregnancy
Idioma:
En
Revista:
Hum Vaccin Immunother
Ano de publicação:
2018
Tipo de documento:
Article
País de afiliação:
Estados Unidos