Neuropsychiatric adverse events of chloroquine: A real-world pharmacovigilance study using the FAERS database

Kenichiro Sato; Tatsuo Mano; Atsushi Iwata; Tatsushi Toda

This was a retrospective pharmacovigilance study that used the FAERS database. This database contains more than 9 million global case reports of potential adverse events of drugs. On April 1, 2020, we downloaded from the FDA's website (https://www.fda.gov) patient data that were reported between the fourth quarter of 2012 and the fourth quarter of 2019. The FAERS database contains data tables named 'DEMO', 'DRUG', 'REAC', 'OUTC', 'RPSR', 'THER', and 'INDI', of which we mainly used the following 3 tables: 1) 'DEMO', which provides the case ID, sex, age, year of event occurrence, country of event occurrence, and the reporter's type of occupation (e.g., medical doctor, pharmacist, lawyer, consumer); 2) 'REAC', which contains all adverse events that are potentially caused by the drug used by each patient, and 3) 'DRUG', which includes the name, dose, indication, and date of administration and discontinuation of each drug that is possibly associated with that AE. In the 'DRUG' table, the causality assessment of the relationship between each drug and its reported AE is classified by the reporter as 'primary suspected', 'secondary suspected', 'concomitant', or 'interacting'. In our analysis, we included only reports that were classified as 'primary suspected' and 'secondary suspected', to reduce the risk of false positive association in deriving our conclusions. In addition, we included only reports that were reported from medical doctor, pharmacist, or other medical staffs, and not from lawyers or consumers.