Safety of psychotropic medication in pregnancy: A pharmacovigilance study of international safety data in the World Health Organization global individual case safety report (ICSR) database ‘VigiBase’.

Study type

• Study type:
  Non-interventional study
• Scope of the study:
  Assessment of risk minimisation measure implementation or effectiveness

  Drug utilisation

Non-interventional study

• Non-interventional study design:
  Other
• Non-interventional study design, other:
  Case/non-case design

Study drug and medical condition

• Study drug International non-proprietary name (INN) or common name:
  LITHIUM

  VALPROIC ACID

  LAMOTRIGINE

  CARBAMAZEPINE
• Anatomical Therapeutic Chemical (ATC) code:
  (N05A) ANTIPSYCHOTICS

  ANTIPSYCHOTICS

  (N05B) ANXIOLYTICS

  ANXIOLYTICS

  (N06A) ANTIDEPRESSANTS

  ANTIDEPRESSANTS

  (N06BA) Centrally acting sympathomimetics

  Centrally acting sympathomimetics
• Medical condition to be studied:
  Foetal disorder

  Neonatal disorder

  Pregnancy

  Stillbirth

  Abortion spontaneous

  Congenital anomaly

  Foetal malformation
• Additional medical condition(s):
  Specifically, Standardized MedDRA queries:,“Congenital, familial and genetic disorders”, “Foetal disorders”, “Lactation related topics (incl neonatal exposure through breast milk)”, “Neonatal disorders”, “Normal pregnancy conditions and outcomes”, “Pregnancy, labour and delivery complications and risk factors (abortions and stillbirth)”, “Termination of pregnancy and risk of abortion”.

Population studied

• Age groups:
  Preterm newborn infants (0 – 27 days)

  Term newborn infants (0 – 27 days)

  Infants and toddlers (28 days – 23 months)

  Adolescents (12 to < 18 years)

  Adults (18 to < 46 years)
• Special population of interest:
  Pregnant women
• Estimated number of subjects:
  3000000

Study design details

• Main study objective:
  Identify safety signals of individual psychotropic drug use and pregnancy related adverse events using VigiBase, the World Health Organization global individual case safety report (ICSR) database.
• Outcomes:
  Risk of reporting a pregnancy related outcome.
• Data analysis plan:
  Data will be extracted from VigiBasa, a case/non-case design will be used for disproportionality analysis to calculated reporting odds ratios (RORs) with their 95% confidence interval (CI). The measure of disproportionality in this study is the reporting odds ratio (ROR) which corresponds to the ratio of reporting odds between groups exposed and not exposed to each drug of interest.