{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,3,20]],"date-time":"2026-03-20T14:13:02Z","timestamp":1774015982817,"version":"3.50.1"},"reference-count":24,"publisher":"Wiley","issue":"6","license":[{"start":{"date-parts":[[2021,3,17]],"date-time":"2021-03-17T00:00:00Z","timestamp":1615939200000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Pharmacoepidemiology and Drug"],"published-print":{"date-parts":[[2021,6]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec><jats:title>Purpose<\/jats:title><jats:p>To describe the characteristics of adverse event reporting in the United States (US) Food and Drug Administration Adverse Event Reporting System (FAERS) before and after the outbreak of the COVID\u201019 pandemic.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>We included all FAERS reports from the US and Canada from November 7, 2019 to July 15, 2020 and divided the study period into three equal time intervals (pre\u2010pandemic, first pandemic, second pandemic). We focused on methotrexate, a broadly used drug unrelated to COVID\u201019, and (hydroxy)chloroquine, another broadly used drug implicated in COVID\u201019 treatment. Using descriptive statistics, we compared reporting characteristics before and after the COVID\u201019 outbreak.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>During the study period, 366\u2009998 cases (60% female, median age: 59\u2009years) were submitted to FAERS. The daily median number of reports (1796 in the pre\u2010pandemic, 1810 in the second pandemic time interval) and other characteristics remained stable. The daily median number of reports for methotrexate decreased from 28 in the pre\u2010pandemic to 15 in the second pandemic time interval, with no considerable differences in other characteristics. The daily median number of reports for (hydroxy)chloroquine increased slightly from 1 in the pre\u2010pandemic to 3 in the second pandemic time interval, while there were also changes in the demographics of cases and an increase in the proportion of cases reported by health professionals.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusions<\/jats:title><jats:p>The overall reporting to FAERS did not change after the outbreak of the COVID\u201019 pandemic. However, some stimulated reporting was observed for (hydroxy)chloroquine, highlighting the need for caution when conducting pharmacovigilance analyses with substances related to COVID\u201019.<\/jats:p><\/jats:sec>","DOI":"10.1002\/pds.5217","type":"journal-article","created":{"date-parts":[[2021,3,2]],"date-time":"2021-03-02T06:40:05Z","timestamp":1614667205000},"page":"707-715","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":15,"title":["Global <scp>COVID<\/scp>\u201019 pandemic and reporting behavior \u2010 An analysis of the Food and Drug Administration adverse events reporting system"],"prefix":"10.1002","volume":"30","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-9462-8661","authenticated-orcid":false,"given":"Michael","family":"D\u00f6rks","sequence":"first","affiliation":[{"name":"Department of Health Services Research Carl von Ossietzky University Oldenburg  Oldenburg Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Kathrin","family":"Jobski","sequence":"additional","affiliation":[{"name":"Department of Health Services Research Carl von Ossietzky University Oldenburg  Oldenburg Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Falk","family":"Hoffmann","sequence":"additional","affiliation":[{"name":"Department of Health Services Research Carl von Ossietzky University Oldenburg  Oldenburg Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-6005-4006","authenticated-orcid":false,"given":"Antonios","family":"Douros","sequence":"additional","affiliation":[{"name":"Departments of Medicine and Epidemiology McGill University  Montreal Quebec Canada"},{"name":"Centre for Clinical Epidemiology Lady Davis Institute \u2013 Jewish General Hospital  Montreal Quebec Canada"},{"name":"Institute of Clinical Pharmacology and Toxicology Charit\u00e9\u2010Universit\u00e4tsmedizin Berlin  Berlin Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2021,3,17]]},"reference":[{"key":"e_1_2_8_2_1","doi-asserted-by":"publisher","DOI":"10.1093\/aje\/kwm215"},{"key":"e_1_2_8_3_1","doi-asserted-by":"publisher","DOI":"10.1007\/s00228-012-1219-4"},{"key":"e_1_2_8_4_1","doi-asserted-by":"publisher","DOI":"10.1002\/pds.4090"},{"key":"e_1_2_8_5_1","doi-asserted-by":"publisher","DOI":"10.1007\/s40801-018-0134-0"},{"key":"e_1_2_8_6_1","doi-asserted-by":"publisher","DOI":"10.1007\/s40264-014-0225-0"},{"key":"e_1_2_8_7_1","doi-asserted-by":"publisher","DOI":"10.1007\/s13300-018-0408-2"},{"key":"e_1_2_8_8_1","doi-asserted-by":"publisher","DOI":"10.1111\/bcp.13098"},{"key":"e_1_2_8_9_1","doi-asserted-by":"publisher","DOI":"10.2165\/00002018-200932010-00002"},{"key":"e_1_2_8_10_1","doi-asserted-by":"publisher","DOI":"10.2165\/00002018-200629050-00003"},{"key":"e_1_2_8_11_1","unstructured":"U. S. Food and Drug Association.Adverse Event Reporting System (AERS). Available at:https:\/\/www.fda.gov\/drugs\/questions-and-answers-fdas-adverse-event-reporting-system-faers\/fda-adverse-event-reporting-system-faers-public-dashboard2021."},{"key":"e_1_2_8_12_1","doi-asserted-by":"publisher","DOI":"10.1007\/s40264-014-0150-2"},{"key":"e_1_2_8_13_1","unstructured":"U.S. Food and Drug Association.FAERS Domestic and Foreign Reports by Year.https:\/\/www.fda.gov\/drugs\/questions-and-answers-fdas-adverse-event-reporting-system-faers\/faers-domestic-and-foreign-reports-year2021."},{"key":"e_1_2_8_14_1","unstructured":"U.S. Food and Drug Administration.Coronavirus (COVID\u201019) Update: FDA Revokes Emergency Use Authorization for Chloroquine and Hydroxychloroquine.https:\/\/www.fda.gov\/news-events\/press-announcements\/coronavirus-covid-19-update-fda-revokes-emergency-use-authorization-chloroquine-and2021."},{"key":"e_1_2_8_15_1","unstructured":"MedDRA MSSO. MedDRA Hierarchy.2021."},{"key":"e_1_2_8_16_1","unstructured":"World Health Organization (WHO).Rolling updates on coronavirus disease (COVID\u201019).https:\/\/www.who.int\/emergencies\/diseases\/novel-coronavirus-2019\/events-as-they-happen2021."},{"key":"e_1_2_8_17_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa2012410"},{"key":"e_1_2_8_18_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa2016638"},{"key":"e_1_2_8_19_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa2019014"},{"key":"e_1_2_8_20_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.drup.2020.100719"},{"key":"e_1_2_8_21_1","doi-asserted-by":"publisher","DOI":"10.1111\/bcp.14546"},{"key":"e_1_2_8_22_1","doi-asserted-by":"publisher","DOI":"10.1002\/art.22159"},{"key":"e_1_2_8_23_1","doi-asserted-by":"publisher","DOI":"10.1111\/bcp.14131"},{"key":"e_1_2_8_24_1","doi-asserted-by":"publisher","DOI":"10.1177\/0961203319843343"},{"key":"e_1_2_8_25_1","unstructured":"U.S. Food and Drug Association.Questions and Answers: NDMA impurities in ranitidine (commonly known as Zantac).https:\/\/www.fda.gov\/drugs\/drug-safety-and-availability\/questions-and-answers-ndma-impurities-ranitidine-commonly-known-zantac2021."}],"container-title":["Pharmacoepidemiology and Drug Safety"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/pds.5217","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/full-xml\/10.1002\/pds.5217","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/pds.5217","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2023,8,30]],"date-time":"2023-08-30T03:09:29Z","timestamp":1693364969000},"score":1,"resource":{"primary":{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/10.1002\/pds.5217"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2021,3,17]]},"references-count":24,"journal-issue":{"issue":"6","published-print":{"date-parts":[[2021,6]]}},"alternative-id":["10.1002\/pds.5217"],"URL":"https:\/\/doi.org\/10.1002\/pds.5217","archive":["Portico"],"relation":{},"ISSN":["1053-8569","1099-1557"],"issn-type":[{"value":"1053-8569","type":"print"},{"value":"1099-1557","type":"electronic"}],"subject":[],"published":{"date-parts":[[2021,3,17]]},"assertion":[{"value":"2020-10-02","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2021-02-18","order":1,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2021-03-17","order":2,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}]}}