Investigating the Safety Profile of Fast‐Track COVID‐19 Drugs Using the FDA Adverse Event Reporting System Database: A Comparative Observational Study
ABSTRACT Background The US Food and Drug Administration (US FDA) granted emergency use authorization (EUA) for multiple coronavirus disease 2019 (COVID‐19) drugs as a medical countermeasure during the COVID‐19 pandemic. Despite these drugs' fast‐track nature, concerns persist regarding their ef...
Gespeichert in:
| Veröffentlicht in: | Pharmacoepidemiology and drug safety 2024-11, Vol.33 (11), p.e70043-n/a |
|---|---|
| Hauptverfasser: | , , |
| Format: | Artikel |
| Sprache: | eng |
| Schlagworte: | |
| Online-Zugang: | Volltext |
| Tags: |
Tag hinzufügen
Keine Tags, Fügen Sie den ersten Tag hinzu!
|
| container_end_page | n/a |
|---|---|
| container_issue | 11 |
| container_start_page | e70043 |
| container_title | Pharmacoepidemiology and drug safety |
| container_volume | 33 |
| creator | Kim, Hyo Jung Yoon, Jeong‐Hwa Lee, Kye Hwa |
| description | ABSTRACT
Background
The US Food and Drug Administration (US FDA) granted emergency use authorization (EUA) for multiple coronavirus disease 2019 (COVID‐19) drugs as a medical countermeasure during the COVID‐19 pandemic. Despite these drugs' fast‐track nature, concerns persist regarding their efficacy and potential adverse effects. Thus, the continuous surveillance and understanding of these drugs' safety profiles are crucial in such scenarios.
Objective
Using the FDA Adverse Event Reporting System (FAERS) database, we aimed to compare the adverse drug reactions (ADRs) of four fast‐track COVID‐19 drugs to explore the potential of real‐world data for providing prompt feedback in clinical settings.
Methods
To evaluate the post‐marketing safety of fast‐track COVID‐19 drugs, we descriptively evaluated the ADRs of four COVID‐19 drugs (bebtelovimab, molnupiravir, nirmatrelvir/ritonavir, and remdesivir) using FAERS data reported from January 2020 to June 2022. We examined FAERS case records of COVID‐19 drugs reported as the “primary suspect drug” as a case group and the records of other drugs as the control. “Serious adverse drug reactions (SADRs)” were defined based on FDA guidelines. Using reporting odds ratios, disproportionality analysis was conducted to determine significant signals for ADRs related to each of the four drugs compared with those of others, both at the preferred term (PT) and system organ class (SOC) levels. To explore the occurrence of reporting each serious outcome reported to the four drugs, we fitted logistic regression models, adjusting for age and sex.
Results
During the study period, 5 248 221 cases were submitted to FAERS, including 17 275 cases of the four COVID‐19 drugs: bebtelovimab (532 cases), molnupiravir (1106 cases), nirmatrelvir/ritonavir (9217 cases), and remdesivir (6420 cases). A total of 64, 46, 116, and 207 PTs with significant disproportionality were identified for each drug, respectively. “Infusion‐related reaction” (18.4%), “diarrhea” (7.4%), “dysgeusia” (11.4%), and “increased alanine aminotransferase” (14.5%) were the most frequently reported SADRs for bebtelovimab, molnupiravir, nirmatrelvir/ritonavir, and remdesivir, respectively. Among the 27 SOCs, statistically significant signals were observed in 10, 3, 0, and 8 SOCs for bebtelovimab, molnupiravir, nirmatrelvir/ritonavir, and remdesivir, respectively. Remdesivir showed a higher occurrence for the reporting of death or life‐threatening ADRs compared with the contr |
| doi_str_mv | 10.1002/pds.70043 |
| format | Article |
| fullrecord | <record><control><sourceid>proquest_cross</sourceid><recordid>TN_cdi_proquest_miscellaneous_3128813580</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><sourcerecordid>3128813580</sourcerecordid><originalsourceid>FETCH-LOGICAL-c2433-6c9a03f81d0cbd35c7d59aee4370f5a7c1bdd7c61e1790750dd7fd81144700233</originalsourceid><addsrcrecordid>eNp1kcFu1DAQhi1ERUvhwAsgS1zgkNZex5uY22rTpStV2optuUaOPVlSkji1naDc-gg983h9knqblgMSJ8_In_-x5kPoAyUnlJDZaafdSUJIzF6hI0qEiCjnyet9zVmU8rk4RG-duyEk3In4DTpkgjNG4_QI_Vm3Azhf7aSv2h32PwFvZQl-xJfWlFUN2JR4JZ1_uLu_slL9wsvNj3UWOipwZvudw9fu5eUqW-CFHsA6wGcDtB5_h87Yp-Tt6Dw0OJNeFtLBV7zAS9N00obBA-BN4cAOoTatrPHW93p8hw5KWTt4_3weo-vV2dXyPLrYfFsvFxeRmsWMRXMlJGFlSjVRhWZcJZoLCRCzhJRcJooWWidqToEmgiSchK7UKaVxHHY2Y-wYfZ5yO2tu-7CMvKmcgrqWLZje5YzO0pQynpKAfvoHvTG9DT-eKJYGB3vqy0Qpa5yzUOadrRppx5ySfC8sD8LyJ2GB_fic2BcN6L_ki6EAnE7A7yBj_H9Sfpltp8hHUCug2w</addsrcrecordid><sourcetype>Aggregation Database</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>3128380430</pqid></control><display><type>article</type><title>Investigating the Safety Profile of Fast‐Track COVID‐19 Drugs Using the FDA Adverse Event Reporting System Database: A Comparative Observational Study</title><source>MEDLINE</source><source>Wiley Online Library Journals Frontfile Complete</source><creator>Kim, Hyo Jung ; Yoon, Jeong‐Hwa ; Lee, Kye Hwa</creator><creatorcontrib>Kim, Hyo Jung ; Yoon, Jeong‐Hwa ; Lee, Kye Hwa</creatorcontrib><description>ABSTRACT
Background
The US Food and Drug Administration (US FDA) granted emergency use authorization (EUA) for multiple coronavirus disease 2019 (COVID‐19) drugs as a medical countermeasure during the COVID‐19 pandemic. Despite these drugs' fast‐track nature, concerns persist regarding their efficacy and potential adverse effects. Thus, the continuous surveillance and understanding of these drugs' safety profiles are crucial in such scenarios.
Objective
Using the FDA Adverse Event Reporting System (FAERS) database, we aimed to compare the adverse drug reactions (ADRs) of four fast‐track COVID‐19 drugs to explore the potential of real‐world data for providing prompt feedback in clinical settings.
Methods
To evaluate the post‐marketing safety of fast‐track COVID‐19 drugs, we descriptively evaluated the ADRs of four COVID‐19 drugs (bebtelovimab, molnupiravir, nirmatrelvir/ritonavir, and remdesivir) using FAERS data reported from January 2020 to June 2022. We examined FAERS case records of COVID‐19 drugs reported as the “primary suspect drug” as a case group and the records of other drugs as the control. “Serious adverse drug reactions (SADRs)” were defined based on FDA guidelines. Using reporting odds ratios, disproportionality analysis was conducted to determine significant signals for ADRs related to each of the four drugs compared with those of others, both at the preferred term (PT) and system organ class (SOC) levels. To explore the occurrence of reporting each serious outcome reported to the four drugs, we fitted logistic regression models, adjusting for age and sex.
Results
During the study period, 5 248 221 cases were submitted to FAERS, including 17 275 cases of the four COVID‐19 drugs: bebtelovimab (532 cases), molnupiravir (1106 cases), nirmatrelvir/ritonavir (9217 cases), and remdesivir (6420 cases). A total of 64, 46, 116, and 207 PTs with significant disproportionality were identified for each drug, respectively. “Infusion‐related reaction” (18.4%), “diarrhea” (7.4%), “dysgeusia” (11.4%), and “increased alanine aminotransferase” (14.5%) were the most frequently reported SADRs for bebtelovimab, molnupiravir, nirmatrelvir/ritonavir, and remdesivir, respectively. Among the 27 SOCs, statistically significant signals were observed in 10, 3, 0, and 8 SOCs for bebtelovimab, molnupiravir, nirmatrelvir/ritonavir, and remdesivir, respectively. Remdesivir showed a higher occurrence for the reporting of death or life‐threatening ADRs compared with the control (adjusted odds ratio (OR) = 2.44, 95% confidence interval (CI) = 2.23–2.59; adjusted OR = 1.82, 95% CI = 1.64–2.02, respectively).
Conclusions
We identified potential ADRs associated with COVID‐19 drugs and provided insights into their real‐world safety. This study demonstrated that real‐world data and real‐time safety reviews could be effective methods for the timely detection of ADR signals of drugs that have received fast‐track approval, as exemplified by COVID‐19 drugs. These findings underscore the importance of the continued surveillance, efficient data processing, and establishment of automated pipelines for real‐time safety reviews.</description><identifier>ISSN: 1053-8569</identifier><identifier>ISSN: 1099-1557</identifier><identifier>EISSN: 1099-1557</identifier><identifier>DOI: 10.1002/pds.70043</identifier><identifier>PMID: 39533148</identifier><language>eng</language><publisher>Chichester, UK: John Wiley & Sons, Inc</publisher><subject><![CDATA[Adenosine Monophosphate - adverse effects ; Adenosine Monophosphate - analogs & derivatives ; Adenosine Monophosphate - therapeutic use ; Adolescent ; Adult ; adverse drug reaction ; Adverse Drug Reaction Reporting Systems - statistics & numerical data ; Adverse events ; Aged ; Alanine - adverse effects ; Alanine - analogs & derivatives ; Alanine - therapeutic use ; Alanine transaminase ; Antibodies, Monoclonal, Humanized - adverse effects ; Antiviral Agents - adverse effects ; Antiviral Agents - therapeutic use ; Child ; Child, Preschool ; Coronaviruses ; COVID-19 ; COVID-19 - epidemiology ; COVID-19 Drug Treatment ; Cytidine - analogs & derivatives ; Databases, Factual - statistics & numerical data ; Diarrhea ; Drug Combinations ; Drug development ; Drugs ; FDA adverse event reporting system ; Female ; Humans ; Hydroxylamines ; Infant ; Male ; Middle Aged ; Observational studies ; Pharmacovigilance ; post‐marketing surveillance ; Product Surveillance, Postmarketing - methods ; Product Surveillance, Postmarketing - statistics & numerical data ; real‐world data ; Regression analysis ; Ritonavir ; Ritonavir - adverse effects ; Safety ; Side effects ; Statistical analysis ; United States - epidemiology ; United States Food and Drug Administration ; Young Adult]]></subject><ispartof>Pharmacoepidemiology and drug safety, 2024-11, Vol.33 (11), p.e70043-n/a</ispartof><rights>2024 The Author(s). published by John Wiley & Sons Ltd.</rights><rights>2024 The Author(s). Pharmacoepidemiology and Drug Safety published by John Wiley & Sons Ltd.</rights><rights>2024. This article is published under http://creativecommons.org/licenses/by-nc-nd/4.0/ (the “License”). Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License.</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><cites>FETCH-LOGICAL-c2433-6c9a03f81d0cbd35c7d59aee4370f5a7c1bdd7c61e1790750dd7fd81144700233</cites><orcidid>0000-0001-9555-0926 ; 0000-0002-7593-7020 ; 0000-0002-9150-3732</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://onlinelibrary.wiley.com/doi/pdf/10.1002%2Fpds.70043$$EPDF$$P50$$Gwiley$$Hfree_for_read</linktopdf><linktohtml>$$Uhttps://onlinelibrary.wiley.com/doi/full/10.1002%2Fpds.70043$$EHTML$$P50$$Gwiley$$Hfree_for_read</linktohtml><link.rule.ids>314,776,780,1411,27901,27902,45550,45551</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/39533148$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Kim, Hyo Jung</creatorcontrib><creatorcontrib>Yoon, Jeong‐Hwa</creatorcontrib><creatorcontrib>Lee, Kye Hwa</creatorcontrib><title>Investigating the Safety Profile of Fast‐Track COVID‐19 Drugs Using the FDA Adverse Event Reporting System Database: A Comparative Observational Study</title><title>Pharmacoepidemiology and drug safety</title><addtitle>Pharmacoepidemiol Drug Saf</addtitle><description>ABSTRACT
Background
The US Food and Drug Administration (US FDA) granted emergency use authorization (EUA) for multiple coronavirus disease 2019 (COVID‐19) drugs as a medical countermeasure during the COVID‐19 pandemic. Despite these drugs' fast‐track nature, concerns persist regarding their efficacy and potential adverse effects. Thus, the continuous surveillance and understanding of these drugs' safety profiles are crucial in such scenarios.
Objective
Using the FDA Adverse Event Reporting System (FAERS) database, we aimed to compare the adverse drug reactions (ADRs) of four fast‐track COVID‐19 drugs to explore the potential of real‐world data for providing prompt feedback in clinical settings.
Methods
To evaluate the post‐marketing safety of fast‐track COVID‐19 drugs, we descriptively evaluated the ADRs of four COVID‐19 drugs (bebtelovimab, molnupiravir, nirmatrelvir/ritonavir, and remdesivir) using FAERS data reported from January 2020 to June 2022. We examined FAERS case records of COVID‐19 drugs reported as the “primary suspect drug” as a case group and the records of other drugs as the control. “Serious adverse drug reactions (SADRs)” were defined based on FDA guidelines. Using reporting odds ratios, disproportionality analysis was conducted to determine significant signals for ADRs related to each of the four drugs compared with those of others, both at the preferred term (PT) and system organ class (SOC) levels. To explore the occurrence of reporting each serious outcome reported to the four drugs, we fitted logistic regression models, adjusting for age and sex.
Results
During the study period, 5 248 221 cases were submitted to FAERS, including 17 275 cases of the four COVID‐19 drugs: bebtelovimab (532 cases), molnupiravir (1106 cases), nirmatrelvir/ritonavir (9217 cases), and remdesivir (6420 cases). A total of 64, 46, 116, and 207 PTs with significant disproportionality were identified for each drug, respectively. “Infusion‐related reaction” (18.4%), “diarrhea” (7.4%), “dysgeusia” (11.4%), and “increased alanine aminotransferase” (14.5%) were the most frequently reported SADRs for bebtelovimab, molnupiravir, nirmatrelvir/ritonavir, and remdesivir, respectively. Among the 27 SOCs, statistically significant signals were observed in 10, 3, 0, and 8 SOCs for bebtelovimab, molnupiravir, nirmatrelvir/ritonavir, and remdesivir, respectively. Remdesivir showed a higher occurrence for the reporting of death or life‐threatening ADRs compared with the control (adjusted odds ratio (OR) = 2.44, 95% confidence interval (CI) = 2.23–2.59; adjusted OR = 1.82, 95% CI = 1.64–2.02, respectively).
Conclusions
We identified potential ADRs associated with COVID‐19 drugs and provided insights into their real‐world safety. This study demonstrated that real‐world data and real‐time safety reviews could be effective methods for the timely detection of ADR signals of drugs that have received fast‐track approval, as exemplified by COVID‐19 drugs. These findings underscore the importance of the continued surveillance, efficient data processing, and establishment of automated pipelines for real‐time safety reviews.</description><subject>Adenosine Monophosphate - adverse effects</subject><subject>Adenosine Monophosphate - analogs & derivatives</subject><subject>Adenosine Monophosphate - therapeutic use</subject><subject>Adolescent</subject><subject>Adult</subject><subject>adverse drug reaction</subject><subject>Adverse Drug Reaction Reporting Systems - statistics & numerical data</subject><subject>Adverse events</subject><subject>Aged</subject><subject>Alanine - adverse effects</subject><subject>Alanine - analogs & derivatives</subject><subject>Alanine - therapeutic use</subject><subject>Alanine transaminase</subject><subject>Antibodies, Monoclonal, Humanized - adverse effects</subject><subject>Antiviral Agents - adverse effects</subject><subject>Antiviral Agents - therapeutic use</subject><subject>Child</subject><subject>Child, Preschool</subject><subject>Coronaviruses</subject><subject>COVID-19</subject><subject>COVID-19 - epidemiology</subject><subject>COVID-19 Drug Treatment</subject><subject>Cytidine - analogs & derivatives</subject><subject>Databases, Factual - statistics & numerical data</subject><subject>Diarrhea</subject><subject>Drug Combinations</subject><subject>Drug development</subject><subject>Drugs</subject><subject>FDA adverse event reporting system</subject><subject>Female</subject><subject>Humans</subject><subject>Hydroxylamines</subject><subject>Infant</subject><subject>Male</subject><subject>Middle Aged</subject><subject>Observational studies</subject><subject>Pharmacovigilance</subject><subject>post‐marketing surveillance</subject><subject>Product Surveillance, Postmarketing - methods</subject><subject>Product Surveillance, Postmarketing - statistics & numerical data</subject><subject>real‐world data</subject><subject>Regression analysis</subject><subject>Ritonavir</subject><subject>Ritonavir - adverse effects</subject><subject>Safety</subject><subject>Side effects</subject><subject>Statistical analysis</subject><subject>United States - epidemiology</subject><subject>United States Food and Drug Administration</subject><subject>Young Adult</subject><issn>1053-8569</issn><issn>1099-1557</issn><issn>1099-1557</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2024</creationdate><recordtype>article</recordtype><sourceid>24P</sourceid><sourceid>EIF</sourceid><recordid>eNp1kcFu1DAQhi1ERUvhwAsgS1zgkNZex5uY22rTpStV2optuUaOPVlSkji1naDc-gg983h9knqblgMSJ8_In_-x5kPoAyUnlJDZaafdSUJIzF6hI0qEiCjnyet9zVmU8rk4RG-duyEk3In4DTpkgjNG4_QI_Vm3Azhf7aSv2h32PwFvZQl-xJfWlFUN2JR4JZ1_uLu_slL9wsvNj3UWOipwZvudw9fu5eUqW-CFHsA6wGcDtB5_h87Yp-Tt6Dw0OJNeFtLBV7zAS9N00obBA-BN4cAOoTatrPHW93p8hw5KWTt4_3weo-vV2dXyPLrYfFsvFxeRmsWMRXMlJGFlSjVRhWZcJZoLCRCzhJRcJooWWidqToEmgiSchK7UKaVxHHY2Y-wYfZ5yO2tu-7CMvKmcgrqWLZje5YzO0pQynpKAfvoHvTG9DT-eKJYGB3vqy0Qpa5yzUOadrRppx5ySfC8sD8LyJ2GB_fic2BcN6L_ki6EAnE7A7yBj_H9Sfpltp8hHUCug2w</recordid><startdate>202411</startdate><enddate>202411</enddate><creator>Kim, Hyo Jung</creator><creator>Yoon, Jeong‐Hwa</creator><creator>Lee, Kye Hwa</creator><general>John Wiley & Sons, Inc</general><general>Wiley Subscription Services, Inc</general><scope>24P</scope><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7TK</scope><scope>K9.</scope><scope>7X8</scope><orcidid>https://orcid.org/0000-0001-9555-0926</orcidid><orcidid>https://orcid.org/0000-0002-7593-7020</orcidid><orcidid>https://orcid.org/0000-0002-9150-3732</orcidid></search><sort><creationdate>202411</creationdate><title>Investigating the Safety Profile of Fast‐Track COVID‐19 Drugs Using the FDA Adverse Event Reporting System Database: A Comparative Observational Study</title><author>Kim, Hyo Jung ; Yoon, Jeong‐Hwa ; Lee, Kye Hwa</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c2433-6c9a03f81d0cbd35c7d59aee4370f5a7c1bdd7c61e1790750dd7fd81144700233</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2024</creationdate><topic>Adenosine Monophosphate - adverse effects</topic><topic>Adenosine Monophosphate - analogs & derivatives</topic><topic>Adenosine Monophosphate - therapeutic use</topic><topic>Adolescent</topic><topic>Adult</topic><topic>adverse drug reaction</topic><topic>Adverse Drug Reaction Reporting Systems - statistics & numerical data</topic><topic>Adverse events</topic><topic>Aged</topic><topic>Alanine - adverse effects</topic><topic>Alanine - analogs & derivatives</topic><topic>Alanine - therapeutic use</topic><topic>Alanine transaminase</topic><topic>Antibodies, Monoclonal, Humanized - adverse effects</topic><topic>Antiviral Agents - adverse effects</topic><topic>Antiviral Agents - therapeutic use</topic><topic>Child</topic><topic>Child, Preschool</topic><topic>Coronaviruses</topic><topic>COVID-19</topic><topic>COVID-19 - epidemiology</topic><topic>COVID-19 Drug Treatment</topic><topic>Cytidine - analogs & derivatives</topic><topic>Databases, Factual - statistics & numerical data</topic><topic>Diarrhea</topic><topic>Drug Combinations</topic><topic>Drug development</topic><topic>Drugs</topic><topic>FDA adverse event reporting system</topic><topic>Female</topic><topic>Humans</topic><topic>Hydroxylamines</topic><topic>Infant</topic><topic>Male</topic><topic>Middle Aged</topic><topic>Observational studies</topic><topic>Pharmacovigilance</topic><topic>post‐marketing surveillance</topic><topic>Product Surveillance, Postmarketing - methods</topic><topic>Product Surveillance, Postmarketing - statistics & numerical data</topic><topic>real‐world data</topic><topic>Regression analysis</topic><topic>Ritonavir</topic><topic>Ritonavir - adverse effects</topic><topic>Safety</topic><topic>Side effects</topic><topic>Statistical analysis</topic><topic>United States - epidemiology</topic><topic>United States Food and Drug Administration</topic><topic>Young Adult</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Kim, Hyo Jung</creatorcontrib><creatorcontrib>Yoon, Jeong‐Hwa</creatorcontrib><creatorcontrib>Lee, Kye Hwa</creatorcontrib><collection>Wiley Online Library Open Access</collection><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>Neurosciences Abstracts</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>MEDLINE - Academic</collection><jtitle>Pharmacoepidemiology and drug safety</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Kim, Hyo Jung</au><au>Yoon, Jeong‐Hwa</au><au>Lee, Kye Hwa</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Investigating the Safety Profile of Fast‐Track COVID‐19 Drugs Using the FDA Adverse Event Reporting System Database: A Comparative Observational Study</atitle><jtitle>Pharmacoepidemiology and drug safety</jtitle><addtitle>Pharmacoepidemiol Drug Saf</addtitle><date>2024-11</date><risdate>2024</risdate><volume>33</volume><issue>11</issue><spage>e70043</spage><epage>n/a</epage><pages>e70043-n/a</pages><issn>1053-8569</issn><issn>1099-1557</issn><eissn>1099-1557</eissn><abstract>ABSTRACT
Background
The US Food and Drug Administration (US FDA) granted emergency use authorization (EUA) for multiple coronavirus disease 2019 (COVID‐19) drugs as a medical countermeasure during the COVID‐19 pandemic. Despite these drugs' fast‐track nature, concerns persist regarding their efficacy and potential adverse effects. Thus, the continuous surveillance and understanding of these drugs' safety profiles are crucial in such scenarios.
Objective
Using the FDA Adverse Event Reporting System (FAERS) database, we aimed to compare the adverse drug reactions (ADRs) of four fast‐track COVID‐19 drugs to explore the potential of real‐world data for providing prompt feedback in clinical settings.
Methods
To evaluate the post‐marketing safety of fast‐track COVID‐19 drugs, we descriptively evaluated the ADRs of four COVID‐19 drugs (bebtelovimab, molnupiravir, nirmatrelvir/ritonavir, and remdesivir) using FAERS data reported from January 2020 to June 2022. We examined FAERS case records of COVID‐19 drugs reported as the “primary suspect drug” as a case group and the records of other drugs as the control. “Serious adverse drug reactions (SADRs)” were defined based on FDA guidelines. Using reporting odds ratios, disproportionality analysis was conducted to determine significant signals for ADRs related to each of the four drugs compared with those of others, both at the preferred term (PT) and system organ class (SOC) levels. To explore the occurrence of reporting each serious outcome reported to the four drugs, we fitted logistic regression models, adjusting for age and sex.
Results
During the study period, 5 248 221 cases were submitted to FAERS, including 17 275 cases of the four COVID‐19 drugs: bebtelovimab (532 cases), molnupiravir (1106 cases), nirmatrelvir/ritonavir (9217 cases), and remdesivir (6420 cases). A total of 64, 46, 116, and 207 PTs with significant disproportionality were identified for each drug, respectively. “Infusion‐related reaction” (18.4%), “diarrhea” (7.4%), “dysgeusia” (11.4%), and “increased alanine aminotransferase” (14.5%) were the most frequently reported SADRs for bebtelovimab, molnupiravir, nirmatrelvir/ritonavir, and remdesivir, respectively. Among the 27 SOCs, statistically significant signals were observed in 10, 3, 0, and 8 SOCs for bebtelovimab, molnupiravir, nirmatrelvir/ritonavir, and remdesivir, respectively. Remdesivir showed a higher occurrence for the reporting of death or life‐threatening ADRs compared with the control (adjusted odds ratio (OR) = 2.44, 95% confidence interval (CI) = 2.23–2.59; adjusted OR = 1.82, 95% CI = 1.64–2.02, respectively).
Conclusions
We identified potential ADRs associated with COVID‐19 drugs and provided insights into their real‐world safety. This study demonstrated that real‐world data and real‐time safety reviews could be effective methods for the timely detection of ADR signals of drugs that have received fast‐track approval, as exemplified by COVID‐19 drugs. These findings underscore the importance of the continued surveillance, efficient data processing, and establishment of automated pipelines for real‐time safety reviews.</abstract><cop>Chichester, UK</cop><pub>John Wiley & Sons, Inc</pub><pmid>39533148</pmid><doi>10.1002/pds.70043</doi><tpages>17</tpages><orcidid>https://orcid.org/0000-0001-9555-0926</orcidid><orcidid>https://orcid.org/0000-0002-7593-7020</orcidid><orcidid>https://orcid.org/0000-0002-9150-3732</orcidid><oa>free_for_read</oa></addata></record> |
| fulltext | fulltext |
| identifier | ISSN: 1053-8569 |
| ispartof | Pharmacoepidemiology and drug safety, 2024-11, Vol.33 (11), p.e70043-n/a |
| issn | 1053-8569 1099-1557 1099-1557 |
| language | eng |
| recordid | cdi_proquest_miscellaneous_3128813580 |
| source | MEDLINE; Wiley Online Library Journals Frontfile Complete |
| subjects | Adenosine Monophosphate - adverse effects Adenosine Monophosphate - analogs & derivatives Adenosine Monophosphate - therapeutic use Adolescent Adult adverse drug reaction Adverse Drug Reaction Reporting Systems - statistics & numerical data Adverse events Aged Alanine - adverse effects Alanine - analogs & derivatives Alanine - therapeutic use Alanine transaminase Antibodies, Monoclonal, Humanized - adverse effects Antiviral Agents - adverse effects Antiviral Agents - therapeutic use Child Child, Preschool Coronaviruses COVID-19 COVID-19 - epidemiology COVID-19 Drug Treatment Cytidine - analogs & derivatives Databases, Factual - statistics & numerical data Diarrhea Drug Combinations Drug development Drugs FDA adverse event reporting system Female Humans Hydroxylamines Infant Male Middle Aged Observational studies Pharmacovigilance post‐marketing surveillance Product Surveillance, Postmarketing - methods Product Surveillance, Postmarketing - statistics & numerical data real‐world data Regression analysis Ritonavir Ritonavir - adverse effects Safety Side effects Statistical analysis United States - epidemiology United States Food and Drug Administration Young Adult |
| title | Investigating the Safety Profile of Fast‐Track COVID‐19 Drugs Using the FDA Adverse Event Reporting System Database: A Comparative Observational Study |
| url | https://sfx.bib-bvb.de/sfx_tum?ctx_ver=Z39.88-2004&ctx_enc=info:ofi/enc:UTF-8&ctx_tim=2025-02-13T01%3A45%3A05IST&url_ver=Z39.88-2004&url_ctx_fmt=infofi/fmt:kev:mtx:ctx&rfr_id=info:sid/primo.exlibrisgroup.com:primo3-Article-proquest_cross&rft_val_fmt=info:ofi/fmt:kev:mtx:journal&rft.genre=article&rft.atitle=Investigating%20the%20Safety%20Profile%20of%20Fast%E2%80%90Track%20COVID%E2%80%9019%20Drugs%20Using%20the%20FDA%20Adverse%20Event%20Reporting%20System%20Database:%20A%20Comparative%20Observational%20Study&rft.jtitle=Pharmacoepidemiology%20and%20drug%20safety&rft.au=Kim,%20Hyo%20Jung&rft.date=2024-11&rft.volume=33&rft.issue=11&rft.spage=e70043&rft.epage=n/a&rft.pages=e70043-n/a&rft.issn=1053-8569&rft.eissn=1099-1557&rft_id=info:doi/10.1002/pds.70043&rft_dat=%3Cproquest_cross%3E3128813580%3C/proquest_cross%3E%3Curl%3E%3C/url%3E&disable_directlink=true&sfx.directlink=off&sfx.report_link=0&rft_id=info:oai/&rft_pqid=3128380430&rft_id=info:pmid/39533148&rfr_iscdi=true |