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Sexual dysfunctions associated with antipsychotic drug intake: a retrospective analysis of the FDA adverse events reporting system (FAERS).
Naunyn Schmiedebergs Arch Pharmacol
January 2025
University Clinic for Psychiatry and Psychotherapy, Brandenburg Medical School Immanuel Klinik Rüdersdorf, Seebad 82/83, Rüdersdorf bei Berlin, 15562, Rüdersdorf, Germany.
Sexual dysfunctions (SD) are common and debilitating side effects of antipsychotics. The current study analyzes the occurrence of antipsychotic-related SD using data from the US Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS). FAERS was queried for sexual dysfunction adverse events (encoded by 35 different MedDRA preferred terms) secondary to amisulpride, aripiprazole, chlorprothixene, clozapine, haloperidol, loxapine, olanzapine, pipamperone, quetiapine, risperidone, and ziprasidone from 2000 to 2023.
View Article and Find Full Text PDFDrug classes associated with the development of fulminant type 1 diabetes: a retrospective analysis using the FDA adverse event reporting system database.
Expert Opin Drug Saf
January 2025
Department of Endocrinology, Guang'anmen Hospital of China Academy of Chinese Medical Sciences, Beijing, China.
Background: Fulminant type 1 diabetes mellitus (FT1DM) is a severe subtype of type 1 diabetes characterized by rapid onset, metabolic disturbances, and irreversible insulin secretion failure. Recent studies have suggested associations between FT1DM and certain medications, warranting further investigation.
Objectives: This study aims to analyze drugs associated with an increased risk of FT1DM using the Food and Drug Administration Adverse Event Reporting System (FAERS) database.
The Potential Metalloestrogenic Effect of Aluminum on Breast Cancer Risk for Antiperspirant Users.
Int J Mol Sci
December 2024
Students' Scientific Society at the Department of Toxicology, Faculty of Pharmacy, Wroclaw Medical University, 50-556 Wroclaw, Poland.
The etiopathogenesis of breast cancer depends on genetic conditions, but recently more attention has been paid to the dependence of BC on certain environmental factors, for example, metalloestrogens, which include aluminum (Al) contained in antiperspirants used daily. The use of Al derivatives in antiperspirants in concentrations specified by the FDA, as well as European regulations (SCCS, 2020), do not classify Al as a hazardous and carcinogenic substance for humans. However, Al used to treat excessive sweating raises concerns, as many in vitro studies indicate that it can cause gene instability, change gene expression or increase oxidative stress, and also affect the body's hormonal balance as a metalloestrogen.
View Article and Find Full Text PDFDeath incidents following transcatheter edge-to-edge repair (TEER) with the MitraClip device: analysis of 10-years post-marketing death reports from the Manufacturer and User Facility Device Experience (MAUDE) registry.
BMC Cardiovasc Disord
January 2025
Department of Cardiology, Peking University International Hospital, Life Park Road No.1, Life Science Park of Zhongguancun, Chang Ping District, Beijing, 102206, China.
Background: The transcatheter edge-to-edge repair (TEER) technique, facilitated by the MitraClip device, is a minimally invasive intervention designed for high-risk patients with mitral regurgitation (MR). This study conducts a retrospective analysis of death events associated with MitraClip implantation over a ten-year decade, utilizing data from the FDA's Manufacturer and User Facility Device Experience (MAUDE) database to evaluate trends in safety outcomes.
Methods: A comprehensive search of the publicly accessible MAUDE database was conducted to retrieve reports of deaths and injuries related to MitraClip implantation from October 2013 to September 2023.
Postmarketing safety evaluation of belimumab: a pharmacovigilance analysis.
Lupus Sci Med
January 2025
Department of Otolaryngology-Head and Neck Surgery, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, Hubei, China
Objective: The present study aimed to provide a comprehensive evaluation of the postmarketing safety of belimumab based on the Food and Drug Administration Adverse Event Reporting System (FAERS) database.
Methods: Adverse event (AE) reports in the FAERS database from January 2021 to December 2023 were extracted to perform the disproportionality analysis by calculating the reporting OR. The clinical characteristics and onset times of AEs were investigated.
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