-
OncoTargets and Therapy 2023As a novel third-generation ALK tyrosine kinase inhibitor (TKI), lorlatinib has shown excellent systemic and intracranial activity in non-small cell lung cancer (NSCLC)... (Review)
Review
As a novel third-generation ALK tyrosine kinase inhibitor (TKI), lorlatinib has shown excellent systemic and intracranial activity in non-small cell lung cancer (NSCLC) patients who carry sensitizing ALK-activating mutations and progress on first- and second-generation TKIs. In comparison with other ALK-TKIs, lorlatinib has a unique safety profile for hyperlipidemia and central nervous system adverse events. Lorlatinib-induced adverse events are well tolerated, permanent discontinuations are rarely reported, and dose modifications and/or standard medical therapy are useful for the management of adverse events. Our present study reviews the safety profile of lorlatinib as well as the relevant management strategies. Our present study aims to provide a practical guide for the scientific management and application of lorlatinib.
PubMed: 37694103
DOI: 10.2147/OTT.S426989 -
Current Radiopharmaceuticals Apr 2024Radiopharmaceuticals are radioactive compounds used for diagnostic or therapeutic purposes which are most often administered intravenously. Adverse events that may...
BACKGROUND AND PURPOSE
Radiopharmaceuticals are radioactive compounds used for diagnostic or therapeutic purposes which are most often administered intravenously. Adverse events that may induce both adverse reactions and drug-to-drug interactions with changes in expected biodistribution, potentially affecting patient safety and diagnostic accuracy. Adverse reactions are relatively rare due to the small doses and under-reporting is the norm. The aim of this study is to increase awareness of the need to report in order to create protocols for the management of such adverse events among professionals in a Nuclear Medicine Department.
METHODS
A reporting system was established a decade ago through an electronic form to enhance adverse event registration. The radiopharmacist collects data for further communication with National Health authorities and develops an annual report with recommendations on the management of these adverse events.
RESULTS
A total of 128 reports were collected, including 65 cases of extravasations, 18 adverse reactions, and 45 drug interactions. Over the years, reporting has been increasing, adverse reactions occurred at a higher incidence than reported in the literature, and each anomalous biodistribution was analysed for possible drug interaction. The annual reports have been used to develop a local guideline for the management of adverse reactions and recommendations for discontinuation of treatment to avoid interactions with radiopharmaceuticals.
CONCLUSION
The recognition of adverse events associated with radiopharmaceuticals is increasing, underlining the need for vigilant reporting and improved management strategies. An efficient reporting system promotes awareness of possible interactions between radiopharmaceuticals and other medicines and their potential adverse reactions to enhance patient safety.
PubMed: 38685803
DOI: 10.2174/0118744710284298240419115911 -
Vaccine Nov 2023The safety of human papillomavirus (HPV) vaccines has been evaluated continuously in pre-licensure clinical trials, post-marketing surveillance systems, and...
The safety of human papillomavirus (HPV) vaccines has been evaluated continuously in pre-licensure clinical trials, post-marketing surveillance systems, and observational studies. Most studies have found no significant association between serious adverse events and HPV vaccination. However, these studies have focused on Western populations; similar studies focusing on Asian populations are insufficient. Our retrospective cohort study used the HPV-vaccination records of junior high-school adolescent girls aged 12-15 years between 2013 and 2018 in Taiwan's National Immunization Information System and linked them to a registry for beneficiaries in Taiwan's National Health Insurance Database (NHID) to establish the vaccinated group. We selected 19 serious diseases as serious adverse events. We compared the incidence rates of these serious adverse events between the vaccinated group and girls in the same age group population, and we calculated the standardized incidence ratio (SIR) to evaluate the risk of serious adverse events after HPV vaccination. Because of the onset of different types of diseases, we set three periods after the subjects received HPV vaccination: within 3 months, within 1 year, and during the study period (2013-2018). The results showed the incidence rates and the SIRs of 19 selected adverse events. Among the 19 selected serious adverse events, the disease with the highest incidence rate during the study period was fibromyalgia (73.23 cases per million population), and the disease with the lowest incidence rate during the study period was Crohn's disease (0.15 cases per million population). The results showed no statistically significant increases in the risk of 19 selected serious adverse events and indicated no association between HPV vaccination and serious adverse events. Given the benefits and safety of HPV vaccination, our research can reduce concerns about vaccine side effects, inform health policies and improve public and clinician's acceptance of HPV vaccine policy.
Topics: Adolescent; Female; Humans; Papillomavirus Infections; Papillomavirus Vaccines; Retrospective Studies; Taiwan; Vaccination; Child
PubMed: 37949754
DOI: 10.1016/j.vaccine.2023.11.010 -
Clinics in Geriatric Medicine Nov 2023Older adults are given therapies to enhance the quality and longevity of life, but with the benefits of medication therapy also comes the potential for adverse drug... (Review)
Review
Older adults are given therapies to enhance the quality and longevity of life, but with the benefits of medication therapy also comes the potential for adverse drug events (ADEs). Avoiding ADEs has become a national health priority with substantial impact on health outcomes and health care costs. The presence of multimorbidity, changes in physiologic function, and polypharmacy make older adults more vulnerable to medication-related ADEs. Use of interactive support tools in the form of geriatric-friendly medication order sets and geriatric consultations along with pharmacist-led medication review and optimization are imperative to decrease the occurrence of ADEs and unnecessary prescribing cascades.
Topics: Humans; Aged; Inappropriate Prescribing; Drug-Related Side Effects and Adverse Reactions; Multimorbidity; Polypharmacy; Emergency Service, Hospital
PubMed: 37798069
DOI: 10.1016/j.cger.2023.04.008 -
Frontiers in Pharmacology 2023The musculoskeletal toxicity of immune checkpoint inhibitors (ICIs) is receiving increasing attention with clinical experience. Nevertheless, the absence of a...
The musculoskeletal toxicity of immune checkpoint inhibitors (ICIs) is receiving increasing attention with clinical experience. Nevertheless, the absence of a systematic investigation into the musculoskeletal toxicity profile of ICIs currently results in the under-recognition of associated adverse events. Further and more comprehensive investigations are warranted to delineate the musculoskeletal toxicity profile of ICIs and characterize these adverse events. The present study employed the FDA Adverse Event Reporting System database to collect adverse events between January 2010 and March 2021. We utilized both the reporting odds ratio and the Bayesian confidence propagation neural network algorithms to identify suspected musculoskeletal adverse events induced by ICIs. Subsequently, the clinical characteristics and comorbidities of the major musculoskeletal adverse events were analyzed. The risk of causing these events with combination therapy monotherapy was compared using logistic regression model and Ω shrinkage measure model. The musculoskeletal toxicity induced by ICIs primarily involves muscle tissue, including neuromuscular junctions, fascia, tendons, and tendon sheaths, as well as joints, spine, and bones, including cartilage. The toxicity profile of PD-1/PD-L1 and CTLA-4 inhibitors varies, wherein the PD-1 inhibitor pembrolizumab exhibits a heightened overall risk of inducing musculoskeletal adverse events. The major ICIs-induce musculoskeletal adverse events, encompassing conditions such as myositis, neuromyopathy (including myasthenia gravis, Lambert-Eaton myasthenic syndrome, Guillain-Barré syndrome, and Chronic inflammatory demyelinating polyradiculoneuropathy), arthritis, fractures, myelitis, spinal stenosis, Sjogren's syndrome, fasciitis, tenosynovitis, rhabdomyolysis, rheumatoid myalgia, and chondrocalcinosis. Our study provides clinical characteristics and comorbidities of the major ICIs-induced musculoskeletal adverse events. Furthermore, the combination therapy of nivolumab and ipilimumab does not result in a statistically significant escalation of the risk associated with the major musculoskeletal adverse events. Immune checkpoint inhibitors administration triggers a range of musculoskeletal adverse events, warranting the optimization of their management during clinical practice.
PubMed: 37881181
DOI: 10.3389/fphar.2023.1199031 -
Child and Adolescent Mental Health Sep 2023Adverse event monitoring in studies of psychotherapy is crucial to clinical decision-making, particularly for weighing of benefits and harms of treatment approaches. In... (Review)
Review
BACKGROUND
Adverse event monitoring in studies of psychotherapy is crucial to clinical decision-making, particularly for weighing of benefits and harms of treatment approaches. In this systematic review, we identified how adverse events are defined, measured, and reported in studies of psychosocial interventions for children with mental disorders.
METHOD
Medline, PsycINFO, Embase, ProQuest Dissertations and Theses Global, and the Cochrane Library were searched from January 2011-January 2023, and Google Scholar from January 2011-February 2023. English language experimental and quasi-experimental studies that evaluated the efficacy or effectiveness of psychosocial interventions for childhood mental disorders were included. Information on the definition, assessment, and report of adverse events was extracted using a checklist based on Good Clinical Practice guidelines.
RESULTS
In this review, 117 studies were included. Studies most commonly involved treating anxiety disorders or obsessive-compulsive disorder (32/117; 27%); 44% of the experimental interventions tested (52/117) were cognitive behavioral therapies. Adverse events were monitored in 36 studies (36/117; 31%) with a protocol used in 19 of these studies to guide monitoring (19/36; 53%). Twenty-seven different events were monitored across the studies with hospitalization the most frequently monitored (3/36; 8%). Event severity was fully assessed in 6 studies (17%) and partially assessed in 12 studies (33%). Only 4/36 studies (11%) included assessing events for cause.
CONCLUSIONS
To date, adverse events have been inconsistently defined, measured and reported in psychosocial intervention studies of childhood mental health disorders. Information on adverse events is an essential knowledge component for understanding the potential impacts and risks of therapeutic interventions.
Topics: Humans; Child; Psychotherapy; Cognitive Behavioral Therapy; Anxiety Disorders
PubMed: 37463769
DOI: 10.1111/camh.12661 -
Pharmaceuticals (Basel, Switzerland) Mar 2024Antibiotic-related adverse events are common in both adults and children, and knowledge of the factors that favor the development of antibiotic-related adverse events is... (Review)
Review
Antibiotic-related adverse events are common in both adults and children, and knowledge of the factors that favor the development of antibiotic-related adverse events is essential to limit their occurrence and severity. Genetics can condition the development of antibiotic-related adverse events, and the screening of patients with supposed or demonstrated specific genetic mutations may reduce drug-related adverse events. This narrative review discusses which genetic variations may influence the risk of antibiotic-related adverse events and which conclusions can be applied to clinical practice. An analysis of the literature showed that defined associations between genetic variations and specific adverse events are very few and that, at the moment, none of them have led to the implementation of a systematic screening process for patients that must be treated with a given antibiotic in order to select those at risk of specific adverse events. On the other hand, in most of the cases, more than one variation is implicated in the determination of adverse events, and this can be a limitation in planning a systematic screening. Moreover, presently, the methods used to establish whether a patient carries a "dangerous" genetic mutation require too much time and waiting for the result of the test can be deleterious for those patients urgently requiring therapy. Further studies are needed to definitively confirm which genetic variations are responsible for an increased risk of a well-defined adverse event.
PubMed: 38543117
DOI: 10.3390/ph17030331 -
Journal of Ophthalmic Inflammation and... Nov 2023Unresolved retinal fluid and high injection burden are major challenges for patients with neovascular age-related macular degeneration. Brolucizumab addresses these...
BACKGROUND
Unresolved retinal fluid and high injection burden are major challenges for patients with neovascular age-related macular degeneration. Brolucizumab addresses these challenges by providing robust vision gains and superior fluid resolution, with the potential for longer treatment intervals. Brolucizumab has been associated with adverse events of retinal vasculitis and retinal vascular occlusion typically in the presence of intraocular inflammation (IOI). To define the incidence of the adverse events, Novartis convened an external safety review committee, which found a rate of 4.6% for definite or probable IOI, 3.3% for retinal vasculitis, and 2.1% for retinal vascular occlusion in the HAWK and HARRIER trials. Novartis also established a coalition to explore 4 areas regarding the adverse events: root cause, patient characterization, event mitigation and vigilance, and treatment protocols for the adverse events. Based on the coalition findings, a risk mitigation framework was developed. Prior to initiating treatment with brolucizumab, it is important to weigh the potential benefit against risk of adverse events and to consider patient risk factors such as prior history of IOI and/or retinal vascular occlusion. To mitigate the potential for IOI-related adverse events, it is important to conduct a thorough dilated eye examination before each injection and closely monitor patients throughout treatment. Patients should be educated on symptoms of IOI to monitor for. Brolucizumab should not be injected in the presence of active IOI. If an adverse event is identified, prompt and intensive treatment should be considered.
CONCLUSION
Progress has been made in understanding how to mitigate IOI-related adverse events following treatment with brolucizumab.
PubMed: 37995057
DOI: 10.1186/s12348-023-00369-8 -
Journal of Affective Disorders Feb 2024This study aims to analyze the adverse events (AEs) of Cariprazine based on the FAERS database, providing evidence for its safety surveillance.
OBJECTIVE
This study aims to analyze the adverse events (AEs) of Cariprazine based on the FAERS database, providing evidence for its safety surveillance.
METHODS
For signal quantification of Cariprazine-related AEs, we used disproportionality analysis including the Ratio of Odds Ratio (ROR), Proportional Reporting Ratio (PRR), Bayesian Confidence Propagation Neural Network (BCPNN), and Multi-Item Gamma Poisson Shrinker (MGPS) algorithms.
RESULTS
We selected Cariprazine-related AE reports from the FAERS database from the fourth quarter of 2015 to the first quarter of 2023, and performed a detailed data analysis. Out of a total of 12,278,580 case reports, 3659 were found to be directly related to Cariprazine. We identified 140 Preferred Terms (PT) to describe these AEs, finding that they involved 27 organ systems. Specifically, AEs related to eye disorders such as Cataract cortical, Cataract nuclear, Accommodation disorder, Lenticular opacities, Oculogyric crisis, Dyschromatopsia were not explicitly mentioned in the drug's leaflet, indicating the presence of new ADR signals.
CONCLUSION
Analysis of the FAERS database identified AEs associated with Cariprazine, notably in eye disorders not previously documented in the drug's official leaflet. These findings emphasize the need for continuous post-market surveillance and awareness among healthcare professionals regarding potential new ADR signals.
Topics: Humans; United States; Adverse Drug Reaction Reporting Systems; Bayes Theorem; Drug-Related Side Effects and Adverse Reactions; Cataract; Eye Diseases
PubMed: 37992768
DOI: 10.1016/j.jad.2023.11.076