Post-marketing safety evaluation of Vortioxetine: A decade-long pharmacovigilance study based on the FAERS database

Journal of Affective Disorders, Journal Year: 2025, Volume and Issue: unknown

Published: March 1, 2025

Language: Английский

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Drug‐Related Hypertension: A Disproportionality Analysis Leveraging the FDA Adverse Event Reporting System

Journal of Clinical Hypertension, Journal Year: 2025, Volume and Issue: 27(3)

Published: March 1, 2025

ABSTRACT Hypertension exerts a significant global disease burden, adversely affecting the well‐being of billions. Alarmingly, drug‐related hypertension remains an area that has not been comprehensively investigated. Therefore, this study is designed to utilize adverse event reports (AERs) from US Food and Drug Administration's Adverse Event Reporting System (FAERS) more identify drugs may potentially lead hypertension. Specifically, total 207 233 AERs were extracted FAERS, spanning time period 2004 2024. Based on these reports, presented top 40 most frequently reported be associated with post‐administration in different genders. Furthermore, we employed four disproportionality analysis methods, including Odds Ratio (ROR), Proportional (PRR), Bayesian Confidence Propagation Neural Network (BCPNN), Empirical Bayes Geometric Mean (EBGM), pinpoint three strongest signals relation across age gender subgroups. Some drugs, such as rofecoxib, lenvatinib, celecoxib, found appear both frequency signal strength lists. These results contribute comprehensive understanding cardiovascular safety profiles pharmacological agents, suggesting necessity blood pressure monitoring following administration.

Language: Английский

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A real-world pharmacovigilance study using disproportionality analysis of united states food and drug administration adverse event reporting system events for vinca alkaloids: comparing vinorelbine and Vincristine

Expert Opinion on Drug Safety, Journal Year: 2024, Volume and Issue: unknown

Published: Sept. 28, 2024

Vinca alkaloids are widely used in cancer treatment for their ability to target microtubule dynamics. While efficacy treating certain cancers is well-established, the full spectrum of adverse event profiles remains an area ongoing research.

Language: Английский

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A real-world data analysis of tirzepatide in the FDA adverse event reporting system (FAERS) database

Frontiers in Pharmacology, Journal Year: 2024, Volume and Issue: 15

Published: June 7, 2024

Background Tirzepatide, a glucose-dependent insulinotropic polypeptide (GIP) receptor and glucagon-like peptide-1 (GLP-1) agonist, is indicated for chronic weight management in adults with obesity or overweight as an adjunct to reduced-calorie diet increased physical activity. However, the safety profile of Tirzepatide-associated adverse events requires comprehensive evaluation. Methods The AE reports from first quarter 2022 third 2023 were selected by exploring FDA Adverse Event Reporting System (FAERS) database. new unexpected potenial signals detected using disproportionality analysis, including reporting odds ratio(ROR), proportional ratio (PRR) Bayesian confidence propagation neural network (BCPNN) empirical Bayes geometric mean(EBGM). Then MedDRA was used systematically classify results. Results A total 1,904,481 case obtained 2022Q2 2023Q3. Forty-sixth tirzepatide-induced ADRs at preferred terms (PTs) level are associated 8 system organ class In addition, this study uncovered multiple anticipated ADRs, such gastrooesophageal reflux disease, dyspepsia, vomiting, line drug labels. Moreover, significant PTs level, incorrect dose administered, injection site haemorrhage, appetite, discovered linked Injury, poisoning, procedural complications, General disorders administration conditions, Metabolism nutrition Organ Class level. Conclusion This offered perspectives on monitoring, surveillance, reactions related tirzepatide. outcomes severe their respective detection signals, along event important consider efforts enhance clinical medication when

Language: Английский

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Evolving treatment strategies for early-life seizures in Tuberous Sclerosis Complex: A review and treatment algorithm

Epilepsy & Behavior, Journal Year: 2024, Volume and Issue: 161, P. 110123 - 110123

Published: Nov. 1, 2024

Language: Английский

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Adverse event signal analysis of remimazolam using the FDA adverse event reporting system database

Acta Anaesthesiologica Scandinavica, Journal Year: 2025, Volume and Issue: 69(3)

Published: Feb. 13, 2025

Abstract Background Remimazolam, a novel ultra‐short‐acting benzodiazepine, has gained popularity in various anesthetic applications due to its pharmacokinetic advantages. However, as use increases, safety concerns also rise, necessitating thorough examination. Additionally, the limited reports on side effects require broader investigation better understand drug's profile. Methods This observational study systematically investigated adverse drug events (ADEs) associated with remimazolam using FAERS database from Q1 2020 Q4 2023. The primary objective was assess potential signals and provide comprehensive information for clinical regulatory purposes. Results A total of 67 cases 161 ADEs were identified. incidence higher patients aged >45 years, particularly those >65 years. Intravenous general anaesthesia most common administration method. Notable ADE included serious such allergic reactions, respiratory cardiac arrest, vascular access occlusion. Conclusion Clinicians should be vigilant about reactions remimazolam, especially older patients, avoid off‐label until more data are available. Continuous monitoring post‐market surveillance is essential uncovering undetected ensuring safe remimazolam. Editorial comment analyzed database, identifying like arrests, site occlusions, patients. findings highlight need monitoring, cautious use, ongoing post‐marketing surveillance.

Language: Английский

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A real-world disproportionality analysis of ripretinib data mining of the public version of FDA adverse event reporting system

Frontiers in Pharmacology, Journal Year: 2025, Volume and Issue: 16

Published: March 18, 2025

Tyrosine kinase inhibitors (TKIs) are the preferred targeted therapy for advanced gastrointestinal stromal tumors (GIST). Ripretinib, first tyrosine switch control inhibitor, has not yet been extensively studied long-term safety in large populations. This study evaluates Ripretinib-related adverse events (AEs) real-world applications by analyzing data from FDA's Adverse Event Reporting System (FAERS). To quantify signals of AEs, we employed several disproportionality analyses: Odds Ratio (ROR), Proportional (PRR), Bayesian Confidence Propagation Neural Network (BCPNN), and Multi-item Gamma Poisson Shrinker (MGPS). In FAERS database, out 7,064,646 reports, 3,161 were identified as related to Ripretinib with 438 significant terms. The most common reactions tiredness, hair loss, nausea, constipation, diarrhea, loss appetite, palmar-plantar erythrodysesthesia syndrome, vomiting. These align medication instructions reports corresponding clinical trials. Notably, label includes unexpected AEs such "hepatic neoplasm", "hair texture abnormal", "metastases liver" "red blood cell count decreased". median onset time was 99 days, an interquartile range 27-245 days. Most cases (26.74%, n = 165) occurred within month administration. Our findings observations. We novel signatures indicating that prospective studies necessary confirm these clarify their implications. results could provide valuable evidence guide further on Ripretinib.

Language: Английский

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Association of PI3K/AKT/mTOR Pathway with Cancer and Its Therapeutic Implications

Published: Jan. 1, 2025

Language: Английский

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Post-market safety profile and suicide/self-injury risk signals of dextromethorphan/bupropion: a real-world pharmacovigilance study

European Journal of Clinical Pharmacology, Journal Year: 2025, Volume and Issue: unknown

Published: April 22, 2025

Language: Английский

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A Real‐World Disproportionality Analysis of Histamine H2‐Receptors Antagonists (Famotidine): A Pharmacovigilance Study Based on Spontaneous Reports in the FDA Adverse Event Reporting System

Drug Development Research, Journal Year: 2025, Volume and Issue: 86(1)

Published: Jan. 16, 2025

Famotidine is an H2 receptor antagonist and currently used on a large scale in gastroenterology. However, may also cause severe toxicity to organ systems, including the blood system, digestive urinary system. The objective of this study was scientifically systematically investigate adverse events (AEs) real world through FDA Adverse Event Reporting System (FAERS) database. A disproportionality analysis quantify signals AEs associated with FAERS data from first quarter 2004 2023. clinical features, onset time, oral intravenous administration consequences induced were further analyzed. Among four tests, we found several that not mentioned drug label. For example, abdominal pain upper, discomfort, dyspepsia, liver disorder, gastrooesophageal reflux disease, rhabdomyolysis. These are consistent instructions. Interestingly, unreported AEs, such as: cerebral infarction, hypocalcaemia, hallucination, visual, hypomagnesaemia, hypoparathyroidism, diabetes insipidus, vulvovaginal candidiasis, retro-orbital neoplasm, neuroblastoma recurrent, malignant cranial nerve neoplasm. Most our findings observations labels, possible new unexpected signals, which suggest need for prospective studies confirm these results explain their relationships. Our provide valuable evidence safety studies.

Language: Английский

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