Expert Opinion on Drug Safety最新文献_第9页

What does real-world data reveal about cangrelor's safety? An analysis of FDA adverse event reporting system (FAERS) database.

IF 3 3区医学

Expert Opinion on Drug Safety Pub Date : 2025-02-20 DOI: 10.1080/14740338.2025.2467812

Zhaojun Wang, Junhang Zhang, Donglei Shi, Li Wei

{"title":"What does real-world data reveal about cangrelor's safety? An analysis of FDA adverse event reporting system (FAERS) database.","authors":"Zhaojun Wang, Junhang Zhang, Donglei Shi, Li Wei","doi":"10.1080/14740338.2025.2467812","DOIUrl":"https://doi.org/10.1080/14740338.2025.2467812","url":null,"abstract":"Background: Cangrelor is used to reduce thrombotic events in adults undergoing percutaneous coronary intervention, but real-world safety data is limited. This study analyzes adverse events (AEs) related to cangrelor using the FDA adverse event reporting system (FAERS) database.Methods: We employed statistical techniques such as the reporting odds ratio, proportional reporting ratio, bayesian confidence propagation neural network, and multi-item gamma poisson shrinker to analyze the data from the FAERS database.Results: Out of a total of 15,011,506 case reports, 209 events were related to cangrelor. Thirty-one preferred term (PT) describing AEs were identified, affecting eight organ systems. The most reported PT was off-label use (n = 163). Several unexpected AEs not listed in the drug labeling emerged, including cardiac arrest, and cardiac failure. Although percutaneous coronary intervention was the most common indication (35.4%), numerous events were associated with off-label use, particularly for conditions such as acute myocardial infarction, antiplatelet therapy, and anticoagulant therapy.Conclusion: Our research reveals both anticipated and unexpected AEs, providing important new information on the safety profile of cangrelor. Furthermore, we have discovered certain problems pertaining to product applications. It is recommended that manufacturers clearly highlight indications and usage instructions, and medical personnel closely follow drug administration protocols.","PeriodicalId":12232,"journal":{"name":"Expert Opinion on Drug Safety","volume":" ","pages":"1-8"},"PeriodicalIF":3.0,"publicationDate":"2025-02-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143457366","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Drug-induced hypokalemia: an analytical study based on real-world drug monitoring data.

IF 3 3区医学

Expert Opinion on Drug Safety Pub Date : 2025-02-20 DOI: 10.1080/14740338.2025.2468861

Bo Song, Liheng Liu, Shichao Dong, Shanshan Wang

{"title":"Drug-induced hypokalemia: an analytical study based on real-world drug monitoring data.","authors":"Bo Song, Liheng Liu, Shichao Dong, Shanshan Wang","doi":"10.1080/14740338.2025.2468861","DOIUrl":"https://doi.org/10.1080/14740338.2025.2468861","url":null,"abstract":"Background: Drug-induced hypokalemia is often associated with adverse clinical outcomes, and unfortunately, the inability to fully understand the drugs that cause hypokalemia puts us in a passive position. This study applies pharmacovigilance data to present a panorama of suspected medications associated with hyperkalemia.Research design and methods: This study used disproportionality analysis to mine adverse events in OpenFDA, identified all suspected drugs that caused hypokalemia, and coded and classified the suspected drugs according to the Anatomical Therapeutic Chemical (ATC) classification system.Results: There are 19755 reports related to drug-induced hypokalemia. The majority of individuals with hypokalemia are females, with a concentrated age range of 65 to 84 years old. After the occurrence of hypokalemia, 8.02% died due to hypokalemia. This study identified 1141 suspected drugs, and among the top 50 drugs, 32 drugs did not include hypokalemia in their instructions. All suspected drugs can be categorized into 73 subgroups according to the ATC classification system.Conclusions: By mining the OpenFDA database, we have identified all suspected drugs that cause hypokalemia and conducted a comprehensive evaluation. The instructions for most of the suspected drugs do not focus on hypokalemia. When the treatment regimen includes other drugs that can directly/indirectly cause a decrease in blood potassium, we recommend actively monitoring blood potassium when using suspected drugs.","PeriodicalId":12232,"journal":{"name":"Expert Opinion on Drug Safety","volume":" ","pages":"1-9"},"PeriodicalIF":3.0,"publicationDate":"2025-02-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143467527","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Novel insights into post-marketing AEs associated with bempedoic acid: a comprehensive analysis utilizing the FAERS database.

IF 3 3区医学

Expert Opinion on Drug Safety Pub Date : 2025-02-19 DOI: 10.1080/14740338.2025.2468868

Xinzhe Wang, Yang Liu, Huawei Han, Jingyun Ma, Ningsheng Tian, Rui Zhu, Xiuwen Shi, Jing Jin, Huifang Zhou

{"title":"Novel insights into post-marketing AEs associated with bempedoic acid: a comprehensive analysis utilizing the FAERS database.","authors":"Xinzhe Wang, Yang Liu, Huawei Han, Jingyun Ma, Ningsheng Tian, Rui Zhu, Xiuwen Shi, Jing Jin, Huifang Zhou","doi":"10.1080/14740338.2025.2468868","DOIUrl":"10.1080/14740338.2025.2468868","url":null,"abstract":"Background: Bempedoic acid is a new drug for lowering low-density lipoprotein cholesterol. This study used the United States Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS) database to retrospectively mine adverse events of oral bempedoic acid in the real world.Research design and methods: The FAERS database was searched to extract the adverse reactions of bempedoic acid from the third quarter of 2020 to the fourth quarter of 2023. After data standardization, the Reporting Odds Ratio (ROR), Proportional Reporting Ratio (PRR), Bayesian Confidence Propagation Neural Network (BCPNN), and Multi-item Gamma Poisson Shrinker (MGPS) methods were used to comprehensively evaluate the adverse reaction signals.Results: A total of 1091 adverse reaction reports were identified, and 70 adverse reaction terms were obtained, involving 22 system categories. According to the ROR signal ranking, the most affected System Organ Classes (SOCs) were \"musculoskeletal and connective tissue disorders,\"\"hepatobiliary disorders,\" and \"investigation.\" Preferred Terms (PTs) with high signal intensity had low density lipoprotein abnormality, elevated blood uric acid, biliary colic, etc. New adverse reaction signals such as esophageal spasm, angina, apathy were reported.Conclusions: This study provide support for clinical monitoring and risk identification of bempedoic acid.","PeriodicalId":12232,"journal":{"name":"Expert Opinion on Drug Safety","volume":" ","pages":"1-8"},"PeriodicalIF":3.0,"publicationDate":"2025-02-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143440397","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Hepatic adverse events associated with anaplastic lymphoma kinase tyrosine kinase inhibitors: a disproportionality analysis based on FAERS database and analysis of drug-gene interaction network.

IF 3 3区医学

Expert Opinion on Drug Safety Pub Date : 2025-02-18 DOI: 10.1080/14740338.2025.2467830

Yan Huo, Minghua Ma, Weiwei Tian, Fang Wang, Xiaolan Liao

{"title":"Hepatic adverse events associated with anaplastic lymphoma kinase tyrosine kinase inhibitors: a disproportionality analysis based on FAERS database and analysis of drug-gene interaction network.","authors":"Yan Huo, Minghua Ma, Weiwei Tian, Fang Wang, Xiaolan Liao","doi":"10.1080/14740338.2025.2467830","DOIUrl":"10.1080/14740338.2025.2467830","url":null,"abstract":"Background: Anaplastic lymphoma kinase (ALK) tyrosine kinase inhibitors (TKIs) are vital for treating ALK-positive cancers but have been associated with liver injury, necessitating further safety investigation. This study examines hepatic adverse event (AE) signals related to ALK TKIs using the U.S. FDA Adverse Event Reporting System (FAERS) and explores potential mechanisms of liver injury.Research design and methods: AE reports from FAERS (Q3 2011 to Q1 2024) related to liver injury were analyzed using the reporting odds ratio (ROR) and multi-item gamma Poisson shrinker (MGPS) methods. Pathway enrichment and drug-gene network analyses were performed to investigate underlying mechanisms.Results: This study identified 2,132 AE reports from the FAERS database linking hepatic AEs to ALK TKIs therapy. Significant signals were detected by ROR and MGPS methods, with common AEs including aminotransferase abnormalities, hyperbilirubinemia, and increased blood alkaline phosphatase, mainly occurring within the first 30 days of treatment. Gene analysis revealed key nodes in the protein-protein interaction (PPI) network, such as PIK3CA, SRC, and PTK2. Enriched KEGG pathways included the MAPK, PI3K-Akt, and Ras signaling.Conclusion: This pharmacovigilance study identifies significant AE signals linking ALK TKIs to liver injury, highlighting potential mechanisms and providing insights for clinical management and patient outcomes.","PeriodicalId":12232,"journal":{"name":"Expert Opinion on Drug Safety","volume":" ","pages":"1-11"},"PeriodicalIF":3.0,"publicationDate":"2025-02-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143413753","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Comparative safety analysis of Hedgehog inhibitor preparations: insights from the FAERS database.

IF 3 3区医学

Expert Opinion on Drug Safety Pub Date : 2025-02-18 DOI: 10.1080/14740338.2025.2466668

Yijiang Liu, Gen Li, Chengliang Wang, Jia Chen, Li Chen

{"title":"Comparative safety analysis of Hedgehog inhibitor preparations: insights from the FAERS database.","authors":"Yijiang Liu, Gen Li, Chengliang Wang, Jia Chen, Li Chen","doi":"10.1080/14740338.2025.2466668","DOIUrl":"10.1080/14740338.2025.2466668","url":null,"abstract":"Background: Vismodegib and sonidegib are currently the only Hedgehog inhibitors (HHIs) approved by the U.S. Food and Drug Administration (FDA) for the treatment of locally advanced BCC (laBCC). However, there is limited systematic research comparing the adverse drug events (ADEs) associated with these two inhibitors.Research design and methods: Data were extracted from the Food and Drug Administration Adverse Event Reporting System (FAERS) for the period from 2019 to the second quarter of 2024. Disproportionality analysis was conducted to compare ADEs between vismodegib and sonidegib.Results: The occurrence of ADEs was notably higher among patients aged ≥ 65 years (72.98%) and males (60.17%). The most frequently reported ADEs associated with HHIs included skeletal muscle and joint diseases and nervous system disorders, particularly muscle spasms and dysgeusia. Differences in adverse reactions between vismodegib and sonidegib were observed, mainly in nervous system, gastrointestinal system, skin and subcutaneous tissue, and renal and urinary disorders.Conclusions: This analysis, using the FAERS database, enhances understanding of the ADE profiles associated with both vismodegib and sonidegib. Further research is needed to validate the hypotheses generated by this study.","PeriodicalId":12232,"journal":{"name":"Expert Opinion on Drug Safety","volume":" ","pages":"1-8"},"PeriodicalIF":3.0,"publicationDate":"2025-02-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143398892","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Post-marketing safety assessment of constipation drugs: a real-world pharmacovigilance study based on FAERS database.

IF 3 3区医学

Expert Opinion on Drug Safety Pub Date : 2025-02-18 DOI: 10.1080/14740338.2025.2467829

Wenyu Zhang, Hui Wang, Shiwei Yang, Xue Pang, Wenqi Hu, Guang Zhang, Xuezhi Xin

{"title":"Post-marketing safety assessment of constipation drugs: a real-world pharmacovigilance study based on FAERS database.","authors":"Wenyu Zhang, Hui Wang, Shiwei Yang, Xue Pang, Wenqi Hu, Guang Zhang, Xuezhi Xin","doi":"10.1080/14740338.2025.2467829","DOIUrl":"10.1080/14740338.2025.2467829","url":null,"abstract":"Background: Laxatives are widely used in the treatment of constipation, but they also have brought many adverse reactions to patients.Methods: We conducted a pharmacovigilance analysis based on the United States Food and Drug Administration Adverse Event Reporting System (FAERS) database to analyze the adverse events of six constipation drugs (linaclotide, lubiprostone, prucalopride, naloxegol, naldemedine, and plecanatide) and to search for clinically meaningful adverse reaction signals. We used disproportionality analysis as the main analysis method to detect pharmacovigilance signals, which includes Frequentist methods and Bayesian methods.Results: Among the reports of the six drugs, more adverse reactions were reported from females than males, and the number of adverse reactions reported was higher in the group of 60-89 years. Linaclotide had the lowest proportion of serious adverse event reports (4.38%), while naldemedine had the highest proportion of serious adverse event reports (25.57%). According to the classification of system organ classification (SOC), the number of gastrointestinal adverse events (N = 8321) was the largest.Conclusions: The adverse reactions of constipation drugs were mainly gastrointestinal symptoms such as diarrhea, abdominal pain and abdominal distension. Linaclotide has the highest safety, and more studies are needed to analyze the cardiovascular safety of lubiprostone.","PeriodicalId":12232,"journal":{"name":"Expert Opinion on Drug Safety","volume":" ","pages":"1-12"},"PeriodicalIF":3.0,"publicationDate":"2025-02-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143413756","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Potential risk analysis of antipsychotics-related constipation from the FDA Adverse Event Reporting System.

IF 3 3区医学

Expert Opinion on Drug Safety Pub Date : 2025-02-17 DOI: 10.1080/14740338.2025.2468857

Sidi He, Chuanwei Li

{"title":"Potential risk analysis of antipsychotics-related constipation from the FDA Adverse Event Reporting System.","authors":"Sidi He, Chuanwei Li","doi":"10.1080/14740338.2025.2468857","DOIUrl":"https://doi.org/10.1080/14740338.2025.2468857","url":null,"abstract":"Background: Antipsychotics-related constipation is a frequently neglected and poorly researched adverse effects in patients in clinical practice. Constipation not only affects the physical health of patients, but also increases the psychological stress to their disease burden, so it requires our more attention.Methods: We queried adverse event reports of antipsychotics-related constipation from the FDA Adverse Event Reporting System (FAERS) database between January 2017 and December 2022.The report odds ratio(ROR) and 95% confidence intervals(CIs) were calculated using case/non-case methods.Results: A total of 562 constipation cases were attributed to atypical antipsychotics (AAPs) during the study period. Except for aripiprazole and ziprasidone, the p values of the other drugs were all less than 0.05. The RORs values in descending order:amisulpride(ROR = 4.07),paliperidone(ROR = 2.73),quetiapine(ROR = 1.83),clozapine(ROR = 1.61), olanzapine(ROR = 1.50), risperidone(ROR = 0.71).Conclusion: This study found that clozapine, olanzapine, amsulpride, quetiapine and paliperidone were correlated with constipation, while risperidone had the least effect on gastrointestinal function. Future analysis of the FAERS database in conjunction with other data sources will be essential for continuous monitoring of antipsychotics-related constipation.","PeriodicalId":12232,"journal":{"name":"Expert Opinion on Drug Safety","volume":" ","pages":""},"PeriodicalIF":3.0,"publicationDate":"2025-02-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143440409","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Assessing the risk of acute kidney injury associated with a four-drug regimen for heart failure: a ten-year real-world pharmacovigilance analysis based on FAERS events.

IF 3 3区医学

Expert Opinion on Drug Safety Pub Date : 2025-02-17 DOI: 10.1080/14740338.2025.2467822

Sen Lin, Ruiqi Zhao, Huimin Zhang, Yanwen Liang, Jiansuo Lin, Mengjiao Yu, Danfei Li, Bei Zhang, Lanyue Ma, Lisheng Peng

{"title":"Assessing the risk of acute kidney injury associated with a four-drug regimen for heart failure: a ten-year real-world pharmacovigilance analysis based on FAERS events.","authors":"Sen Lin, Ruiqi Zhao, Huimin Zhang, Yanwen Liang, Jiansuo Lin, Mengjiao Yu, Danfei Li, Bei Zhang, Lanyue Ma, Lisheng Peng","doi":"10.1080/14740338.2025.2467822","DOIUrl":"10.1080/14740338.2025.2467822","url":null,"abstract":"Background: The four-drug regimen for heart failure with reduced ejection fraction (HFrEF) significantly reduces the risks of hospitalization and mortality. To identify key adverse drug events (ADEs) warranting attention with this regimen, we conducted a real-world pharmacovigilance analysis based on the FDA Adverse Event Reporting System (FAERS) events.Research design and methods: We collected ADE reports of the four-drug regimen from FAERS that matched this regimen over a 10-year period. Disproportionality analysis and subgroup analysis were performed using four algorithms. Time-to-onset (TTO) analysis was used to assess the temporal risk patterns of ADE occurrence. Lastly, logistic regression was applied to investigate the relationship-value between patient characteristics and ADEs.Results: A total of 1,237 cases with 6,580 ADE reports were collected. Disproportionality analysis identified the most frequent ADEs as hypotension, acute kidney injury (AKI), and hyperkalemia. TTO analysis revealed a median TTO of 39 days for all important medical events, and the median TTO for AKI was 28 days, both fitting an early failure curve.Conclusion: In the comprehensive management of HFrEF with the four-drug regimen, in addition to routine monitoring of ADEs such as hypotension and hyperalemia, early-onset AKI should be a particular focus.","PeriodicalId":12232,"journal":{"name":"Expert Opinion on Drug Safety","volume":" ","pages":"1-10"},"PeriodicalIF":3.0,"publicationDate":"2025-02-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143413746","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Postmarketing safety of [¹⁷⁷Lu]Lu-PSMA-617 radioligand therapy for prostate cancer: a disproportionality analysis of the FDA adverse event reporting system.

IF 3 3区医学

Expert Opinion on Drug Safety Pub Date : 2025-02-17 DOI: 10.1080/14740338.2025.2466673

Yan Zhao, Na Wang, Zhaoqi Zhang, Xinming Zhao

{"title":"Postmarketing safety of [177Lu]Lu-PSMA-617 radioligand therapy for prostate cancer: a disproportionality analysis of the FDA adverse event reporting system.","authors":"Yan Zhao, Na Wang, Zhaoqi Zhang, Xinming Zhao","doi":"10.1080/14740338.2025.2466673","DOIUrl":"10.1080/14740338.2025.2466673","url":null,"abstract":"Background: [177Lu]Lu-PSMA-617 (Pluvicto), a new radioligand therapy that targets prostate-specific membrane antigen (PSMA), has been approved to treat metastatic castration-resistant prostate cancer (mCRPC). However, the real-world safety profile of [177Lu]Lu-PSMA-617 has not been systemically evaluated.Research design and methods: Adverse event reports for [177Lu]Lu-PSMA-617 were retrieved from April 2022 to June 2024 from The Food and Drug Administration Adverse Event Reporting System (FAERS) database. Disproportionality analysis was conducted by four algorithms: reporting odds ratio (ROR), proportional reporting ratio (PRR), Multi-Item Gamma Poisson Shrinker (MGPS) and Bayesian Confidence Propagation Neural Network (BCPNN). Subgroup analysis, time-to-onset and sensitivity analysis were also employed.Results: 384,2712 adverse event reports were retrieved, of which 870 were associated with [177Lu]Lu-PSMA-617 in prostate cancer patients. We identified known adverse events (fatigue/asthenia, anemia, thrombocytopenia and nausea) and discovered adverse events not specified on the label (loss of libido, hydronephrosis, supraventricular tachycardia, tumor lysis syndrome, and tumor flare). Subgroup analysis revealed high-risk signals included stomatitis, pneumonia, leukopenia, and sepsis for patients aged over 85. The median onset time was 55 days (interquartile range 24-124 days).Conclusions: The findings provide new insights into the adverse events of [177Lu]Lu-PSMA-617 and valuable references for clinical applications of radioligand therapy for mCRPC.","PeriodicalId":12232,"journal":{"name":"Expert Opinion on Drug Safety","volume":" ","pages":"1-9"},"PeriodicalIF":3.0,"publicationDate":"2025-02-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143398893","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Assessing the safety of topical minoxidil through disproportionality analysis of FAERS reports.

IF 3 3区医学

Expert Opinion on Drug Safety Pub Date : 2025-02-17 DOI: 10.1080/14740338.2025.2467816

Yanbo Li, Bo Liu, Wei Wu, Jian Li

{"title":"Assessing the safety of topical minoxidil through disproportionality analysis of FAERS reports.","authors":"Yanbo Li, Bo Liu, Wei Wu, Jian Li","doi":"10.1080/14740338.2025.2467816","DOIUrl":"10.1080/14740338.2025.2467816","url":null,"abstract":"Background: Topical minoxidil, approved by the FDA in the 1980s, has been widely used to manage androgenetic alopecia. While effective, several adverse events (AEs) related to its use, especially those not well-documented on product labels, remain a concern.Objective: This study aimed to evaluate the safety of topical minoxidil by analyzing AEs reported in the FDA Adverse Event Reporting System (FAERS) from 2004 to 2024, focusing on identifying potential risk signals not highlighted on current product labels.Methods: Adverse event reports (AERs) from FAERS, where topical minoxidil was identified as the primary suspect, were analyzed. Disproportionality analysis methods, Reporting Odds Ratio (ROR), Proportional Reporting Ratio (PRR), Bayesian Confidence Propagation Neural Network (BCPNN), and Multi-Item Gamma Poisson Shrinker (MGPS), were used to assess the relationship between minoxidil and reported AEs.Results: Among 45,130 reports, most were from males (50.88%) and showed a significant increase in incidents since 2015. Newly identified AEs, such as application site acne and cysts, were observed. These AEs are not well represented on product labels.Conclusion: The study identified previously unreported AEs linked to topical minoxidil, underscoring the need for updated patient information and regulatory reassessment to enhance safety and inform clinical practices.","PeriodicalId":12232,"journal":{"name":"Expert Opinion on Drug Safety","volume":" ","pages":"1-8"},"PeriodicalIF":3.0,"publicationDate":"2025-02-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143413749","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0