Background: Emicizumab is the latest treatment for patients with hemophilia A. Its safety in real-world data is limited, and regulatory agencies and clinical researchers have raised concerns about the risk of adverse events.
Aim: This study aimed to detect potential adverse event signals of emicizumab using the FDA Adverse Event Reporting System (FAERS) database.
Method: Data in FAERS from the fourth quarter of 2017 to the second quarter of 2021 were searched. Cases of adverse events were extracted using the Preferred Term in the Medical Dictionary for Regulatory Activities (version 24.0). Disproportionality analysis was performed using the reporting odds ratio (ROR) and information component (IC) methods based on statistical shrinkage transformation.
Results: A total of 5,598,717 patients were included, of which 1,244 took emicizumab. A total of 703 emicizumab-related adverse event signals were mined, and 101 positive signals were detected. Haemarthrosis (ROR/ROR/ROR = 155.62/184.34/131.38, IC/IC/IC = 7.28/7.48/7.01), haemorrhage (ROR/ROR/ROR = 71.01/81.18/62.12, IC/IC/IC = 6.15/6.31/5.94), muscle haemorrhage (ROR/ROR/ROR = 53.38/75.83/37.58, IC/IC/IC = 5.74/6.16/5.15), traumatic haemorrhage (ROR/ROR/ROR = 27.78/46.29/16.67, IC/IC/IC = 4.80/5.40/3.92), haematoma (ROR/ROR/ROR = 18.15/26.35/12.51, IC/IC/IC = 4.18/4.63/3.55), device-related thrombosis (ROR/ROR/ROR = 21.27/37.57/12.04, IC/IC/IC = 4.41/5.08/3.43), and activated partial thromboplastin time prolonged (ROR/ROR/ROR = 20.68/36.51/11.71, IC/IC/IC = 4.37/5.04/3.39) had the strongest signal intensities. Haemorrhage, haemarthrosis, arthralgia, fall, and injection site pain were reported more frequently.
Conclusion: This study found that mild arthralgia and injection site reaction were associated with emicizumab. Attention should also be paid to other serious adverse events related to emicizumab, such as acute myocardial infarction and sepsis, to ensure patient safety.
Download full-text PDF |
Source |
|---|---|
| http://dx.doi.org/10.1007/s11096-022-01514-4 | DOI Listing |
Publication Analysis
Top Keywords
Similar Publications
Quantification of ivermectin in veterinary products consumed off-label as a treatment for COVID-19.
Pharmazie
December 2024
Centre of Excellence for Pharmaceutical Sciences (Pharmacen™), North-West University, Potchefstroom, Republic of South Africa.
The COVID-19 pandemic caused global pandemonium, and due to an unprecedented global response, the popularity and use of (veterinary) ivermectin, amongst many other conceivable 'treatments', experienced a meteoric rise. Ivermectin is a macrocyclic lactone compound belonging to the avermectin drug class and is a registered medicine in many countries, although the most common use is as veterinary medicine. In this study, a fast HPLC method was developed and validated for the quantification of ivermectin in veterinary products that were used off-label by a substantial number of people during COVID-19.
View Article and Find Full Text PDFPhysiology and Pathophysiology of Marathon Running: A narrative Review.
Sports Med Open
January 2025
Institute of Primary Care, University of Zurich, Zurich, Switzerland.
Background: Marathon training and running have many beneficial effects on human health and physical fitness; however, they also pose risks. To date, no comprehensive review regarding both the benefits and risks of marathon running on different organ systems has been published.
Main Body: The aim of this review was to provide a comprehensive review of the benefits and risks of marathon training and racing on different organ systems.
Effect of Acupuncture on Anxiety, Depression, and Quality of Life in Patients with Irritable Bowel Syndrome: A Meta-Analysis.
Int J Behav Med
January 2025
Qilu Hospital of Shandong University, No. 107 Wen Hua Xi Road, Jinan, 250012, Shandong Province, China.
Background: Irritable bowel syndrome (IBS) has been effectively treated with acupuncture, but the significance of quality of life, depression, and anxiety in the assessment of IBS patients has received little consideration. This study examined the impact of acupuncture on depression, anxiety, and quality of life in IBS patients.
Method: PubMed, Cochrane Library, China National Knowledge Infrastructure (CNKI), EMBASE, China Science and Technology Journal Database (VIP), Chinese Biological Medical (CBM, SinoMed) Database, and the Wan Fang Database were among the electronic databases from which relevant randomized controlled trials (RCTs) were systematically retrieved between their inception and July 2023.
Mending a World of Problems: 12-Year Review of Medical Tourism Inbound Complications in a Tertiary Centre.
Aesthetic Plast Surg
January 2025
Department of Plastic and Reconstructive Surgery, Rambam Health Care Campus, 8thHa'Aliya Hashniya st, Haifa, Israel.
Background: Medical tourism is a rapidly expanding multi-billion-dollar industry. Reduced costs, all-inclusive vacation packages that include cosmetic surgery, globalization, and affordable flight expenses have encouraged patients to seek aesthetic procedures in different countries. Cosmetic medical tourism is associated with high complication rates, such as severe infections, wound dehiscence, pain or discomfort, aesthetic dissatisfaction, and even death.
View Article and Find Full Text PDFThe ejaculatory reflex consists of emission and expulsion, with the latter involving rhythmic muscular contractions that propel seminal fluid. Botulinum toxin, through its inhibitory effects, has been hypothesized to improve premature ejaculation (PE). This study evaluates high-quality evidence on botulinum toxin-A injections into the bulbospongiosal muscle as a treatment for PE.
View Article and Find Full Text PDFWant AI Summaries of new PubMed Abstracts delivered to your In-box?
Enter search terms and have AI summaries delivered each week - change queries or unsubscribe any time!