Association between methotrexate-induced Stevens-Johnson syndrome/toxic epidermal necrolysis and furosemide : a real-world disproportionality analysis
BACKGROUND: Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) are rare and life-threatening skin adverse reactions that are usually induced by drugs. This study aimed to assess the association between methotrexate and SJS/TEN when combined with furosemide.
RESEARCH DESIGN AND METHODS: Data on suspicious, interactions (PS, SS, I) from the FDA Adverse Event Reporting System database for 2016-2021 were analyzed using the reporting odds ratio (ROR), information component (IC), proportional reporting ratio (PRR) and the Medications and Health Care Products Regulatory Agency (MHRA).
RESULTS: We identified 28 case reports of TEN associated with the combination of furosemide and methotrexate and 10 reports of SJS associated with furosemide and methotrexate. The association of methotrexate with SJS/TEN was more significant in the entire data set when combined with furosemide than when methotrexate was not combined with furosemide. The association of methotrexate with SJS/TEN remained significant when furosemide was combined with methotrexate in a tumor-based disease context. After sensitivity analysis of the entire dataset as well as all antineoplastic drug datasets, consistent results were observed for TEN.
CONCLUSIONS: Our study confirmed a significant association between methotrexate and SJS/TEN when combined with furosemide, with an increased risk of SJS/TEN.
| Medienart: |
E-Artikel |
|---|
| Erscheinungsjahr: |
2024 |
|---|---|
| Erschienen: |
2024 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:23 |
|---|---|
| Enthalten in: |
Expert opinion on drug safety - 23(2024), 1 vom: 17. Jan., Seite 137-144 |
| Sprache: |
Englisch |
|---|
| Beteiligte Personen: |
Zhuo, Shengnan [VerfasserIn] |
|---|
| Links: |
|---|
| Themen: |
7LXU5N7ZO5 |
|---|
| Anmerkungen: |
Date Completed 14.02.2024 Date Revised 14.02.2024 published: Print-Electronic Citation Status MEDLINE |
|---|
| doi: |
10.1080/14740338.2023.2203482 |
|---|
| funding: |
|
|---|---|
| Förderinstitution / Projekttitel: |
|
| PPN (Katalog-ID): |
NLM355740532 |
|---|
| LEADER | 01000caa a22002652 4500 | ||
|---|---|---|---|
| 001 | NLM355740532 | ||
| 003 | DE-627 | ||
| 005 | 20240214232701.0 | ||
| 007 | cr uuu---uuuuu | ||
| 008 | 231226s2024 xx |||||o 00| ||eng c | ||
| 024 | 7 | |a 10.1080/14740338.2023.2203482 |2 doi | |
| 028 | 5 | 2 | |a pubmed24n1292.xml |
| 035 | |a (DE-627)NLM355740532 | ||
| 035 | |a (NLM)37070136 | ||
| 040 | |a DE-627 |b ger |c DE-627 |e rakwb | ||
| 041 | |a eng | ||
| 100 | 1 | |a Zhuo, Shengnan |e verfasserin |4 aut | |
| 245 | 1 | 0 | |a Association between methotrexate-induced Stevens-Johnson syndrome/toxic epidermal necrolysis and furosemide |b a real-world disproportionality analysis |
| 264 | 1 | |c 2024 | |
| 336 | |a Text |b txt |2 rdacontent | ||
| 337 | |a ƒaComputermedien |b c |2 rdamedia | ||
| 338 | |a ƒa Online-Ressource |b cr |2 rdacarrier | ||
| 500 | |a Date Completed 14.02.2024 | ||
| 500 | |a Date Revised 14.02.2024 | ||
| 500 | |a published: Print-Electronic | ||
| 500 | |a Citation Status MEDLINE | ||
| 520 | |a BACKGROUND: Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) are rare and life-threatening skin adverse reactions that are usually induced by drugs. This study aimed to assess the association between methotrexate and SJS/TEN when combined with furosemide | ||
| 520 | |a RESEARCH DESIGN AND METHODS: Data on suspicious, interactions (PS, SS, I) from the FDA Adverse Event Reporting System database for 2016-2021 were analyzed using the reporting odds ratio (ROR), information component (IC), proportional reporting ratio (PRR) and the Medications and Health Care Products Regulatory Agency (MHRA) | ||
| 520 | |a RESULTS: We identified 28 case reports of TEN associated with the combination of furosemide and methotrexate and 10 reports of SJS associated with furosemide and methotrexate. The association of methotrexate with SJS/TEN was more significant in the entire data set when combined with furosemide than when methotrexate was not combined with furosemide. The association of methotrexate with SJS/TEN remained significant when furosemide was combined with methotrexate in a tumor-based disease context. After sensitivity analysis of the entire dataset as well as all antineoplastic drug datasets, consistent results were observed for TEN | ||
| 520 | |a CONCLUSIONS: Our study confirmed a significant association between methotrexate and SJS/TEN when combined with furosemide, with an increased risk of SJS/TEN | ||
| 650 | 4 | |a Journal Article | |
| 650 | 4 | |a FAERS | |
| 650 | 4 | |a Methotrexate | |
| 650 | 4 | |a SJS/TEN | |
| 650 | 4 | |a combination drugs | |
| 650 | 4 | |a furosemide | |
| 650 | 4 | |a signal generation | |
| 650 | 7 | |a Methotrexate |2 NLM | |
| 650 | 7 | |a YL5FZ2Y5U1 |2 NLM | |
| 650 | 7 | |a Furosemide |2 NLM | |
| 650 | 7 | |a 7LXU5N7ZO5 |2 NLM | |
| 650 | 7 | |a Antineoplastic Agents |2 NLM | |
| 700 | 1 | |a Dong, Tu |e verfasserin |4 aut | |
| 700 | 1 | |a Yue, Zhongsheng |e verfasserin |4 aut | |
| 700 | 1 | |a Qian, Yating |e verfasserin |4 aut | |
| 700 | 1 | |a Liu, Xinling |e verfasserin |4 aut | |
| 700 | 1 | |a Liu, Wei |e verfasserin |4 aut | |
| 773 | 0 | 8 | |i Enthalten in |t Expert opinion on drug safety |d 2002 |g 23(2024), 1 vom: 17. Jan., Seite 137-144 |w (DE-627)NLM126588422 |x 1744-764X |7 nnns |
| 773 | 1 | 8 | |g volume:23 |g year:2024 |g number:1 |g day:17 |g month:01 |g pages:137-144 |
| 856 | 4 | 0 | |u http://dx.doi.org/10.1080/14740338.2023.2203482 |3 Volltext |
| 912 | |a GBV_USEFLAG_A | ||
| 912 | |a GBV_NLM | ||
| 951 | |a AR | ||
| 952 | |d 23 |j 2024 |e 1 |b 17 |c 01 |h 137-144 | ||