The potential favorizing role of drugs in sleep apnea syndrome (SAS) is unknown. This study investigates drugs associated with SAS in a pharmacovigilance database. SAS recorded as adverse drug reactions (ADRs) in VigiBase , the WHO pharmacovigilance database (more than 11 million reports), from 1978 to 2015 was selected. The risk of SAS reports was estimated using the case-noncase method, with cases being SAS and noncases all other recorded ADRs. During this 37-year period, 3325 ADRs including the word SAS were registered (0.05% of the database). Mean age was 51.2 ± 16.9 years with 52% men. ADRs were 'serious' in around 82% of cases. The case-noncase study found an association between SAS and exposition with sodium oxybate, rofecoxib, quetiapine, and clozapine for individual drugs and coxibs, antipsychotics, benzodiazepines, and opium alkaloids for drug classes. The potential role of other drugs is discussed. This study suggests that SAS can be associated with some drugs (mainly psychotropics) that are able to reveal or aggravate such a disease. Physicians should take into account the role of drugs in the etiological appraisal and management of SAS.
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http://dx.doi.org/10.1111/fcp.12264 | DOI Listing |
Background: Antibiomania is the manifestation of manic symptoms secondary to taking an antibiotic, which is a rare side effect. In these cases, the antibiotics most often incriminated are macrolides and quinolones, but to our knowledge, there are no published cases of antibiomania secondary to cotrimoxazole. Furthermore, we also provide an update of pharmacovigilance data concerning antibiomania through a search of the World Health Organization (WHO) database.
View Article and Find Full Text PDFDrug Saf
January 2025
Department of Computational Biomedicine, Cedars-Sinai Medical Center, Los Angeles, CA, USA.
Background: Natural language processing (NLP) and machine learning (ML) techniques may help harness unstructured free-text electronic health record (EHR) data to detect adverse drug events (ADEs) and thus improve pharmacovigilance. However, evidence of their real-world effectiveness remains unclear.
Objective: To summarise the evidence on the effectiveness of NLP/ML in detecting ADEs from unstructured EHR data and ultimately improve pharmacovigilance in comparison to other data sources.
Alzheimers Res Ther
January 2025
Department of Pharmacy, Xuanwu Hospital of Capital Medical University, No. 45, Changchun Street, Xicheng District, Beijing, 100053, People's Republic of China.
Background: The safety data of lecanemab in the post-marketing period has yet to be fully investigated in the current literature. We aimed to identify and characterise the safety profile of lecanemab in the post-marketing period.
Methods: We searched and reviewed the reports submitted to the FDA's Adverse Event Reporting System (FAERS).
Sci Rep
January 2025
Department of pharmacy, Heze University, Heze, 274000, Shandong Province, China.
Progestogens commonly used in the clinic include levonorgestrel, etonogestrel, medroxyprogesterone, hydroxyprogesterone, progesterone, desogestrel, and megestrol. Progestogens are widely used for contraception and the treatment of endometriosis, threatened abortion and other diseases. However, the correlation between progestogen use and depression is not clear.
View Article and Find Full Text PDFPharmacoepidemiol Drug Saf
January 2025
Hunan Institute for Drug Control, Changsha, Hunan, China.
Background And Objectives: Based on the Adverse Event Reporting System (FAERS) data from the US FDA, this study mined the adverse drug reactions of obeticholic acid (OCA) in the real world and provided reference for clinical safe drug use.
Methods: Adverse event reports for OCA from the second quarter of 2016 to the third quarter of 2023 were extracted. The analysis for adverse reaction signal detection was conducted using reporting odds ratio, proportional reporting ratio, Bayesian confidence propagation neural network, and multi-item gamma Poisson shrinker methods.
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