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JACC. Cardiovascular Interventions Feb 2023
Topics: Humans; Percutaneous Coronary Intervention; Treatment Outcome; Coronary Artery Disease; Coronary Artery Bypass
PubMed: 36792255
DOI: 10.1016/j.jcin.2022.11.005 -
Vaccines Apr 2022The Vaccine Adverse Event Reporting System database has been used to report adverse events following several vaccines. We studied the patient population predisposed to... (Review)
Review
The Vaccine Adverse Event Reporting System database has been used to report adverse events following several vaccines. We studied the patient population predisposed to such reactions and how these reactions differ with respect to the vaccine type. We searched the electronic databases PubMed, EMBASE, and Scopus up to 9 July 2021 for any study describing cardiac adverse events attributed to the vaccination. A total of 56 studies met the criteria comprising 340 patients. There were 20 studies describing cardiac adverse events following smallpox vaccination, 11 studies describing adverse events after influenza vaccination, and 18 studies describing adverse events after COVID-19 vaccination. There was a total of six studies describing cardiac adverse events after the pneumococcal vaccine, tetanus toxoid, cholera vaccine, and rabies vaccine. Adverse events following influenza vaccination occurred more commonly in older females within an average duration of four days from vaccination. Pericardial involvement was the most reported adverse event. Adverse events following COVID-19 vaccination happened at a mean age of 42.7 years, more commonly in males, and mostly after a second dose. Adverse events following smallpox vaccination occurred more commonly in younger males, with an average onset of symptoms from vaccination around 16.6 days. Adverse events were mostly myopericarditis; however, the acute coronary syndrome has been reported with some vaccines.
PubMed: 35632455
DOI: 10.3390/vaccines10050700 -
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 -
Frontiers in Psychiatry 2023"Learned helplessness" refers to debilitating outcomes, such as passivity and increased fear, that follow an uncontrollable adverse event, but do not when that event is... (Review)
Review
"Learned helplessness" refers to debilitating outcomes, such as passivity and increased fear, that follow an uncontrollable adverse event, but do not when that event is controllable. The original explanation argued that when events are uncontrollable the animal learns that outcomes are independent of its behavior, and that this is the active ingredient in producing the effects. Controllable adverse events, in contrast, fail to produce these outcomes because they lack the active uncontrollability element. Recent work on the neural basis of helplessness, however, takes the opposite view. Prolonged exposure to aversive stimulation produces the debilitation by potent activation of serotonergic neurons in the brainstem dorsal raphe nucleus. Debilitation is prevented with an instrumental controlling response, which activates prefrontal circuitry detecting control and subsequently blunting the dorsal raphe nucleus response. Furthermore, learning control alters the prefrontal response to future adverse events, thereby preventing debilitation and producing long-term resiliency. The general implications of these neuroscience findings may apply to psychological therapy and prevention, in particular by suggesting the importance of cognitions and control, rather than habits of control.
PubMed: 37229393
DOI: 10.3389/fpsyt.2023.1170417 -
Annual Review of Public Health Apr 2023Heat is a dangerous hazard that causes acute heat illness, chronic disease exacerbations, adverse pregnancy outcomes, and a range of injuries. Risks are highest during... (Review)
Review
Heat is a dangerous hazard that causes acute heat illness, chronic disease exacerbations, adverse pregnancy outcomes, and a range of injuries. Risks are highest during extreme heat events (EHEs), which challenge the capacity of health systems and other critical infrastructure. EHEs are becoming more frequent and severe, and climate change is driving an increasing proportion of heat-related mortality, necessitating more investment in health protection. Climate-resilient health systems are better positioned for EHEs, and EHE preparedness is a form of disaster risk reduction. Preparedness activities commonly take the form of heat action plans (HAPs), with many examples at various administrative scales. HAP activities can be divided into primary prevention, most important in the pre-event phase; secondary prevention, key to risk reduction early in an EHE;and tertiary prevention, important later in the event phase. After-action reports and other postevent evaluation activities are central to adaptive management of this climate-sensitive hazard.
Topics: Female; Pregnancy; Humans; Public Health; Extreme Heat; Climate Change
PubMed: 36608344
DOI: 10.1146/annurev-publhealth-071421-025508 -
Journal of Hand and Microsurgery Jan 2022Our purposes were to (1) characterize the timeline of eight postoperative complications following hand surgery, (2) assess complication timing for the procedures...
Our purposes were to (1) characterize the timeline of eight postoperative complications following hand surgery, (2) assess complication timing for the procedures that account for the majority of adverse events, and (3) determine any differences in complication timing between outpatient and inpatient procedures. Patients undergoing hand, wrist, and forearm procedures from 2005 to 2016 were identified in the National Surgical Quality Improvement Program database. Timing of eight adverse events was characterized. Cox proportional hazards modeling was used to compare adverse event timing between inpatient and outpatient procedures. A total of 59,040 patients were included. The median postoperative day of diagnosis for each adverse event was as follows: myocardial infarction 1, pulmonary embolism 2, acute kidney injury 3, pneumonia 8, deep vein thrombosis 9, sepsis 13, urinary tract infection 15, and surgical site infection 16. Amputations, fasciotomies, and distal radius open reduction internal fixation accounted for the majority of adverse events. Complication timing was significantly earlier in inpatients compared with outpatients for myocardial infarction. This study characterizes postoperative adverse event timing following hand surgery. Surgeons should have the lowest threshold for testing for each complication during the time period of greatest risk. This is a therapeutic, Level III study.
PubMed: 35256826
DOI: 10.1055/s-0040-1709212 -
Journal of Clinical Medicine Sep 2023Febuxostat and allopurinol are the most commonly used uric acid-lowering medications, and their safety is of great concern, especially the cardiovascular adverse...
BACKGROUND
Febuxostat and allopurinol are the most commonly used uric acid-lowering medications, and their safety is of great concern, especially the cardiovascular adverse reactions associated with febuxostat. We propose to study the cardiovascular toxicity of febuxostat and allopurinol using the FDA Adverse Event Reporting System (FAERS) database.
METHODS
A total of 64 quarters of FAERS data were downloaded from 2004 to 2019. Febuxostat- and allopurinol-related cardiovascular adverse events were extracted after data cleaning. Signal detection was conducted by reporting odds ratio (ROR) and proportional reporting ratio (PRR).
RESULTS
There were 2939 and 25,219 reports of febuxostat- and allopurinol-related cardiovascular adverse events (CVAEs), respectively. The most frequent CVAEs with febuxostat and allopurinol were edema peripheral (14.38%) and peripheral swelling (8.76%), respectively. In elderly gout patients, febuxostat is associated with an increased risk of heart failure, ischemic heart disease, hypertension, and cardiomyopathy. Febuxostat in combination with acetic acid derivatives nonsteroidal anti-inflammatory drug (NSAIDS) also increases the risk of cardiovascular adverse events.
CONCLUSIONS
Compared with allopurinol, febuxostat may increase cardiovascular toxicity in patients with gout.
PubMed: 37763029
DOI: 10.3390/jcm12186089 -
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 -
Dermatology and Therapy Feb 2021Brodalumab is a human interleukin-17 receptor A antagonist indicated for the treatment of moderate-to-severe plaque psoriasis in adult patients who are candidates for...
INTRODUCTION
Brodalumab is a human interleukin-17 receptor A antagonist indicated for the treatment of moderate-to-severe plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy and have failed to respond or have lost response to other systemic therapies. In the United States, brodalumab carries a boxed warning about suicidal ideation and behavior; however, no causal association was established between brodalumab and suicides reported during pivotal trials. We have previously reported results from an analysis of 1-year pharmacovigilance data in patients in the United States who took brodalumab, in which the most commonly reported adverse event was psoriasis flare. There were no completed suicides, suicide attempts, or serious fungal infections. Here, we provide a 2-year US pharmacovigilance report.
METHODS
This analysis summarizes pharmacovigilance data reported to Ortho Dermatologics by US patients and healthcare providers from August 15, 2017, through August 14, 2019. The most common adverse events listed in the brodalumab package insert (incidence ≥ 1%; arthralgia, headache, fatigue, diarrhea, oropharyngeal pain, nausea, myalgia, injection-site reactions, influenza, neutropenia, and tinea infections) and adverse events of special interest are reported.
RESULTS
Data were collected from 2677 patients in the United States who took brodalumab, with an estimated exposure of 1656 patient-years. Arthralgia was the most commonly reported adverse event (73 events; 0.04 events per patient-year). No suicide attempts or completed suicides were reported; there were 25 reports of depression. There were 46 serious infections and no serious fungal infections. One event of Crohn's disease was reported, which led to discontinuation. There were 13 malignancies, with none deemed related to brodalumab.
CONCLUSIONS
This pharmacovigilance report supports the safety profile of brodalumab previously reported from long-term analyses of clinical trials and 1-year pharmacovigilance data.
PubMed: 33337520
DOI: 10.1007/s13555-020-00472-x -
Cureus Sep 2022An adverse event is any abnormal clinical finding associated with the use of a therapy. Adverse events are classified by reporting an event's seriousness, expectedness,... (Review)
Review
An adverse event is any abnormal clinical finding associated with the use of a therapy. Adverse events are classified by reporting an event's seriousness, expectedness, and relatedness. Monitoring patient safety is of utmost importance as more and more data becomes available. In reality, very low numbers of adverse events are reported via the official path. Chart review, voluntary reporting, computerized surveillance, and direct observation can detect adverse drug events. Medication errors are commonly seen in hospitals and need provider and system-based interventions to prevent them. The need of the hour in India is to develop and implement medication safety best practices to avoid adverse events. The utility of artificial intelligence techniques in adverse event detection remains unexplored, and their accuracy and precision need to be studied in a controlled setting. There is a need to develop predictive models to assess the likelihood of adverse reactions while testing novel pharmaceutical drugs.
PubMed: 36258971
DOI: 10.7759/cureus.29162