The main pharmacovigilance updates in 2020 are reviewed. Remdesivir in COVID-19: relatively safe but turns out to be less effective than expected. Hydroxychloroquine in COVID-19 : lack of efficacy and risk of arrhythmias. Cytokines storm in COVID-19: may impact pharmacokinetics. VEGF inhibitors: risk of aneurysm and artery dissection. Tofacitinib: dose-dependant risk of venous thromboembolic events. Ondansetron in the first trimester of pregnancy : a highly debated risk of orofacial cleft defects. Fingolimod : contraindicated during pregnancy due to suspected risk of congenital malformations. Ranitidine: global market withdrawal due to contamination with nitrosamines. Ulipristal for uterine fibroids : market withdrawal due to risk of severe liver injury. Ingenol mebutate : market withdrawal due to paradoxical risk of skin cancers.
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Japan's conditional/time-limited early approval program, initiated in 2014, aimed to advance regenerative medicine by expediting market access. However, the withdrawal of autologous skeletal myoblast sheets (Heartsheet) due to ineffectiveness raises concerns about the balance between rapid approval and scientific integrity. While the program seeks to boost innovation, it risks endorsing costly, unclear treatments under national health care.
View Article and Find Full Text PDFBMC Psychiatry
January 2025
Institute of Mental Health, Peking University Sixth Hospital, Beijing, 100191, China.
Background: Few new psychiatric drugs have entered the market in recent decades; in contrast, the number of drugs carrying pharmacogenomic labels continues to increase. For the foreseeable future, the advancement of psychiatry and drug therapy may hinge on personalized treatment. Currently, antipsychotic or antidepressant choices rely heavily on the clinical experience of psychiatrists and potentially lengthy iterative trials.
View Article and Find Full Text PDFPLoS One
January 2025
Animal and Human Health Department, International Livestock Research Institute, Nairobi, Kenya.
Non-conformance with antibiotic withdrawal period guidelines represents a food safety concern, with potential for antibiotic toxicities and allergic reactions as well as selecting for antibiotic resistance. In the Kenyan domestic pig market, conformance with antibiotic withdrawal periods is not a requirement of government legislation and evidence suggests that antibiotic residues may frequently be above recommended limits. In this study, we sought to explore enablers of and barriers to conformance with antibiotic withdrawal periods for pig farms supplying a local independent abattoir in peri-urban Nairobi.
View Article and Find Full Text PDFJ Prev Med Public Health
December 2024
Department of Preventive Medicine, Seoul National University College of Medicine, Seoul, Korea.
Objectives: This study was performed to evaluate the utilization patterns of acid suppressants following the withdrawal of ranitidine in Korea.
Methods: Health Insurance Review & Assessment Service (HIRA) data from January 2016 to May 2023 were utilized to assess the usage of histamine H2 receptor antagonists (H2RAs) and proton pump inhibitors (PPIs) for acid-related diseases. Drug utilization was calculated for each agent based on the defined daily dose (DDD).
Biomedicines
December 2024
Department of Surgery, School of Medicine, University of Missouri Kansas City, Kansas City, MO 64108, USA.
: Exsanguination is a leading cause of preventable death in military and civilian settings due to extensive blood loss and hemorrhagic shock, which trigger systemic effects such as impaired tissue perfusion, hypoxia, inflammation, and multi-organ dysfunction. Standard resuscitation restores blood volume but fails to address critical aspects of hemorrhagic shock, including inflammation, coagulopathy, and reperfusion injury. To address these limitations, novel phospholipid nanoparticle (PNP)-based resuscitative fluids, VBI-S and VBI-1, were developed to modulate nitric oxide (NO) levels, improving hemodynamic stability, tissue oxygenation, and reducing inflammatory injury.
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