Risk Factors for Respiratory Depression Associated with Tramadol Based on the Global Pharmacovigilance Database (VigiBase)
Tramadol, a weak μ-opioid receptor agonist, has been used worldwide for pain management. It is considered to have a favorable safety profile without serious adverse events; however, safety issues of respiratory depression were proposed by regulatory governments. We aimed to examine the risk and cont...
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| Format: | Article |
| Language: | English |
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MDPI AG
2024-02-01
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| Series: | Pharmaceuticals |
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| Online Access: | https://www.mdpi.com/1424-8247/17/2/205 |
| _version_ | 1827342996869218304 |
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| author | Sunny Park Geon-Ho Lee Soyun Kim Solee Kim Yeju Kim Soo-An Choi |
| author_facet | Sunny Park Geon-Ho Lee Soyun Kim Solee Kim Yeju Kim Soo-An Choi |
| author_sort | Sunny Park |
| collection | DOAJ |
| description | Tramadol, a weak μ-opioid receptor agonist, has been used worldwide for pain management. It is considered to have a favorable safety profile without serious adverse events; however, safety issues of respiratory depression were proposed by regulatory governments. We aimed to examine the risk and contributing factors associated with tramadol-related respiratory depression using a real-world database, VigiBase. Disproportionality analysis of tramadol and tramadol/paracetamol was performed using proportional reporting ratios, reporting odds ratios, and information components for all drugs and opioids. Factors related to respiratory depression, including sex, age, presence of abuse, death, and various concomitant medications, were evaluated. Among 140,721 tramadol reports, respiratory depression was reported in 1126 cases, 81.3% of which were deemed serious. Five adverse events were detected as signals of tramadol-related acute central respiratory depression (ACRD) in 882 reports. A higher proportion of ACRD cases in children and adolescents was observed than all adverse events cases of tramadol. Concomitant users of CYP2D6 inhibitors, opioids, benzodiazepines, and anti-depressant drugs showed a higher proportion in ACRD cases than non-ACRD cases. ACRD was related to drug abuse and death. This pharmacovigilance study, using VigiBase, confirmed a high risk of respiratory depression (a serious, potentially fatal adverse event) secondary to the use of tramadol, especially in pediatric patients, drug abusers, or during concomitant use of opioids, benzodiazepines, or antidepressants. |
| first_indexed | 2024-03-07T22:17:42Z |
| format | Article |
| id | doaj.art-3a6c570b2a464547bff006bff557f121 |
| institution | Directory Open Access Journal |
| issn | 1424-8247 |
| language | English |
| last_indexed | 2024-03-07T22:17:42Z |
| publishDate | 2024-02-01 |
| publisher | MDPI AG |
| record_format | Article |
| series | Pharmaceuticals |
| spelling | doaj.art-3a6c570b2a464547bff006bff557f1212024-02-23T15:30:40ZengMDPI AGPharmaceuticals1424-82472024-02-0117220510.3390/ph17020205Risk Factors for Respiratory Depression Associated with Tramadol Based on the Global Pharmacovigilance Database (VigiBase)Sunny Park0Geon-Ho Lee1Soyun Kim2Solee Kim3Yeju Kim4Soo-An Choi5College of Pharmacy and Research Institute of Pharmaceutical Sciences, Korea University, Sejong 30019, Republic of KoreaCollege of Pharmacy, Korea University, Sejong 30019, Republic of KoreaCollege of Pharmacy, Korea University, Sejong 30019, Republic of KoreaCollege of Pharmacy, Korea University, Sejong 30019, Republic of KoreaCollege of Pharmacy, Korea University, Sejong 30019, Republic of KoreaCollege of Pharmacy and Research Institute of Pharmaceutical Sciences, Korea University, Sejong 30019, Republic of KoreaTramadol, a weak μ-opioid receptor agonist, has been used worldwide for pain management. It is considered to have a favorable safety profile without serious adverse events; however, safety issues of respiratory depression were proposed by regulatory governments. We aimed to examine the risk and contributing factors associated with tramadol-related respiratory depression using a real-world database, VigiBase. Disproportionality analysis of tramadol and tramadol/paracetamol was performed using proportional reporting ratios, reporting odds ratios, and information components for all drugs and opioids. Factors related to respiratory depression, including sex, age, presence of abuse, death, and various concomitant medications, were evaluated. Among 140,721 tramadol reports, respiratory depression was reported in 1126 cases, 81.3% of which were deemed serious. Five adverse events were detected as signals of tramadol-related acute central respiratory depression (ACRD) in 882 reports. A higher proportion of ACRD cases in children and adolescents was observed than all adverse events cases of tramadol. Concomitant users of CYP2D6 inhibitors, opioids, benzodiazepines, and anti-depressant drugs showed a higher proportion in ACRD cases than non-ACRD cases. ACRD was related to drug abuse and death. This pharmacovigilance study, using VigiBase, confirmed a high risk of respiratory depression (a serious, potentially fatal adverse event) secondary to the use of tramadol, especially in pediatric patients, drug abusers, or during concomitant use of opioids, benzodiazepines, or antidepressants.https://www.mdpi.com/1424-8247/17/2/205analgesicshypoventilationtramadolpharmacovigilanceWorld Health OrganizationVigiBase |
| spellingShingle | Sunny Park Geon-Ho Lee Soyun Kim Solee Kim Yeju Kim Soo-An Choi Risk Factors for Respiratory Depression Associated with Tramadol Based on the Global Pharmacovigilance Database (VigiBase) Pharmaceuticals analgesics hypoventilation tramadol pharmacovigilance World Health Organization VigiBase |
| title | Risk Factors for Respiratory Depression Associated with Tramadol Based on the Global Pharmacovigilance Database (VigiBase) |
| title_full | Risk Factors for Respiratory Depression Associated with Tramadol Based on the Global Pharmacovigilance Database (VigiBase) |
| title_fullStr | Risk Factors for Respiratory Depression Associated with Tramadol Based on the Global Pharmacovigilance Database (VigiBase) |
| title_full_unstemmed | Risk Factors for Respiratory Depression Associated with Tramadol Based on the Global Pharmacovigilance Database (VigiBase) |
| title_short | Risk Factors for Respiratory Depression Associated with Tramadol Based on the Global Pharmacovigilance Database (VigiBase) |
| title_sort | risk factors for respiratory depression associated with tramadol based on the global pharmacovigilance database vigibase |
| topic | analgesics hypoventilation tramadol pharmacovigilance World Health Organization VigiBase |
| url | https://www.mdpi.com/1424-8247/17/2/205 |
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