scholarly journals Pharmacology and Adverse Events of Emergency-Use Authorized Medication in Moderate to Severe COVID-19

2021 ◽  
Vol 14 (10) ◽  
pp. 955
Author(s):  
Jen-Yu Hsu ◽  
Yan-Chiao Mao ◽  
Po-Yu Liu ◽  
Kuo-Lung Lai
Keyword(s):  
Adverse Events ◽  
Metabolic Pathways ◽  
Case Reports ◽  
Secondary Infection ◽  
Treatment Strategies ◽  
Serious Adverse Events ◽  
Small Molecule Drugs ◽  
Post Market ◽  
Inflammatory Processes ◽  
Effective Drugs

Some effective drugs have been approved or issued an Emergency Use Authorization for the treatment of COVID-19 in hospitalized patients, but post-market surveillance is warranted to monitor adverse events. We reviewed clinical trials and case reports in patients with moderate-to-severe COVID-19 infection who received remdesivir, baricitinib, tocilizumab, or sarilumab. The drug-specific pharmacokinetics, toxicity, and drug interactions are summarized in this study. Remdesivir and baricitinib are small-molecule drugs that are mainly metabolized by the kidneys, while tocilizumab and sarilumab are monoclonal antibody drugs with metabolic pathways that are currently not fully understood. The most common adverse events of these drugs are alterations in liver function, but serious adverse events have rarely been attributed to them. Only a few studies have reported that remdesivir might be cardiotoxic and that baricitinib might cause thromboembolism. Biological agents such as baricitinib, tocilizumab, and sarilumab could inhibit the pathway of inflammatory processes, leading to immune dysregulation, so the risk of secondary infection should be assessed before prescribing. Further recognition of the pathogenic mechanism and risk factors of adverse events is essential for optimizing treatment strategies.

scholarly journals Informing selection of drugs for COVID-19 treatment through adverse events analysis

2021 ◽  
Vol 11 (1) ◽  
Author(s):  
Wenjing Guo ◽  
Bohu Pan ◽  
Sugunadevi Sakkiah ◽  
Zuowei Ji ◽  
Gokhan Yavas ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Adverse Events ◽  
Safety Concern ◽  
Clinical Practices ◽  
Safety Concerns ◽  
Post Market ◽  
Z Scores ◽  
Favorable Safety ◽  
Effective Drugs ◽  
Selection Of

AbstractCoronavirus disease 2019 (COVID-19) is an ongoing pandemic and there is an urgent need for safe and effective drugs for COVID-19 treatment. Since developing a new drug is time consuming, many approved or investigational drugs have been repurposed for COVID-19 treatment in clinical trials. Therefore, selection of safe drugs for COVID-19 patients is vital for combating this pandemic. Our goal was to evaluate the safety concerns of drugs by analyzing adverse events reported in post-market surveillance. We collected 296 drugs that have been evaluated in clinical trials for COVID-19 and identified 28,597,464 associated adverse events at the system organ classes (SOCs) level in the FDA adverse events report systems (FAERS). We calculated Z-scores of SOCs that statistically quantify the relative frequency of adverse events of drugs in FAERS to quantitatively measure safety concerns for the drugs. Analyzing the Z-scores revealed that these drugs are associated with different significantly frequent adverse events. Our results suggest that this safety concern metric may serve as a tool to inform selection of drugs with favorable safety profiles for COVID-19 patients in clinical practices. Caution is advised when administering drugs with high Z-scores to patients who are vulnerable to associated adverse events.

scholarly journals Invasive Fungal Infections in Infants—Focus on Anidulafungin

2013 ◽  
Vol 7 ◽  
pp. CMPed.S8028 ◽  
Author(s):  
Michael H. Wilke
Keyword(s):  
Risk Factors ◽  
Adverse Events ◽  
Safety Profile ◽  
Fungal Infections ◽  
Case Reports ◽  
Small Body ◽  
Pediatric Intensive Care ◽  
Invasive Fungal Infections ◽  
Serious Adverse Events ◽  
Good Safety Profile

Introduction Invasive fungal infection in pediatric intensive care units (PICU) is a rising challenge. Candida species are the most common microorganisms in these infections. Due to growing resistance against fluconazole, echinocandins are being used for the appropriate therapy. However, the recent IDSA guidelines recommend them only in cases where fluconazole or Amphotericin B cause treatment failure or are contraindicated. In a literature review, the importance of invasive fungal infections in PICU settings and the role of anidulafungin shall be examined. Materials and Methods Articles were retrieved form PubMed covering the years 2000–2012. Various search terms were used. Then the articles were clustered in different types like ‘review,’ ‘pharmacokinetics,’ ‘case reports’ and others. Results From 67 search results, 14 articles were selected. Of these, 7 were related to anidulafungin, while 7 were related to echinocandins or fungal infections in the PICU. Anidulafungin was examined in 4 PK/PD studies where a good safety profile was found. No serious adverse events occurred. The articles reporting risk factors show that central venous catheters, receipt of antibiotics, receipt of parenteral nutrition, and neutropenia are the most important independent risk factors for invasive fungal infections in PICU. Three reviews of antifungal agents show that echinocandins may be useful due to their safety profile; micafungin is the best examined one and further trials are needed. Discussion The published literature on invasive fungal infections in PICU settings has grown over the years. There are only a few articles, however, which are directly related to the use of anidulafungin in this setting. A most recent publication showed good PK/PD dynamics and a good safety profile for anidulafungin. So far, no RCT in the area of invasive candidiasis in infants and neonates has been published. A review of currently registered trials at ClinicalTrials.gov has shown one more trial related to PK/PD and two trials that investigate the use of anidulafungin or anidulafungin in combination with Voriconazole in pediatrics. Conclusion The small body of existing literature on anidulafungin in infants shows success in treatment, no drug-related adverse events, and good pharmacodynamics. A dosing of 0.75 mg/kg/day or 1.5 mg/kg/day is as effective as 50 mg/day or 100 mg/day in adults. More trials on the use in clinical reality of PICU or NICU should follow.

scholarly journals Successful Treatment by Surgery and Lenvatinib of a Patient with Adrenal Metastasis of Papillary Thyroid Cancer

2020 ◽  
Vol 2020 ◽  
pp. 1-4
Author(s):  
Hajime Nakamura ◽  
Kohichi Takada ◽  
Kazuyuki Murase ◽  
Hiroki Sakamoto ◽  
Naotaka Hayasaka ◽  
...  
Keyword(s):  
Thyroid Cancer ◽  
Adverse Events ◽  
Papillary Thyroid Cancer ◽  
Surgical Resection ◽  
Tyrosine Kinases ◽  
Treatment Strategies ◽  
Stable State ◽  
Adrenal Metastasis ◽  
Papillary Thyroid ◽  
Serious Adverse Events

Papillary thyroid cancer (PTC) is considered an indolent cancer, but some PTC patients do present with distant metastases and treatment strategies for such patients are not well established. Recently, lenvatinib, an inhibitor of multiple tyrosine kinases, has been introduced to treat patients with advanced PTC but carries a risk of serious adverse events such as hemorrhage. Here, we report a PTC patient with a left adrenal metastasis and lenvatinib-induced hemorrhage who underwent successful surgical resection and was subsequently treated with a lower dose of lenvatinib. The patient has now been in a stable state with no adverse events for nearly two years. This case highlights the importance of surgical resection of metastatic PTC and subsequent lenvatinib therapy, even when the tumor is at an advanced stage.

scholarly journals Feasibility and Safety of 3-Weekly Carboplatin/Paclitaxel Regimen in Advanced Squamous cell Carcinoma of the Anal Canal

2021 ◽  
pp. 1-5
Author(s):  
Abraão Dornellas ◽  
Abraão Dornellas ◽  
Renata C. Bonadio ◽  
Priscila M. G. Moraes ◽  
Maria I. Braghiroli ◽  
...  
Keyword(s):  
Adverse Events ◽  
Cox Regression ◽  
Negative Impact ◽  
Multivariable Analysis ◽  
Treatment Strategies ◽  
Complete Response ◽  
Median Number ◽  
Rank Test ◽  
Hiv Positive ◽  
Serious Adverse Events

Introduction: Anal cancer is a rare disease, and there is a lack of phase 3 studies in the advanced setting. Currently, the standard treatment is based on interAACT phase 2 study using Carboplatin (C) (AUC 5, D1q28) plus Paclitaxel (P) (80 mg/m2, D1,8,15q28). This study demonstrated a median OS of 20m, a response rate of 59% and serious adverse events in 36% of patients (pts). However, this regimen requires more infusions and hospital visits than a 3-weekly CP regimen, resulting in high social and financial cost. Objective: To retrospectively access safety and efficacy of treatment with 3-weekly CP in advanced SCCA. Methods: We performed a single-center retrospective analysis of patients (pts) who received first-line treatment with 3-weekly CP for inoperable locally recurrent or metastatic SCCA between Jun/2011 and Jun/2018. Study data were collected using REDCap®. Survival analyses were estimated with the Kaplan-Meier method and compared by log-rank test. Prognostic factors were evaluated by Cox regression. Results: 47 patients were included. Median age was 57 years, 60% (n=28) were female and 21% (n=10) HIV positive.16% (n=7) had metastatic disease at diagnosis. The majority of pts (n=42) were treated with paclitaxel (P) 175 mg/m2 plus carboplatin (C) AUC 5 every 3 weeks. The median number of cycles was 4 and dose reduction by toxicity was necessary for 30% (n=14). Grade 3/4 adverse events were neutropenia 19% (n=9), anemia 4% (n=2), fatigue 4% (n=2), neuropathy 2% (n=1). Two pts had interruption due to toxicity and no treatment-related death. 64% of patients benefited from treatment, 4% with complete response. The median overall survival (OS) was 10 months(m). In a multivariable analysis, HIV-positive (HIV+) status (HR 3.1; 95%CI 1.8-8.4; p 0.001) and ECOG 2/3 (HR 3.9; 95%CI 1.2-8.1; p 0.01) showed a negative impact on OS. Median OS was 16m for HIV- vs 4m for HIV+ group; and 20m for ECOG 0/1 vs 4m for ECOG 2/3. Conclusion: The present study suggests that 3-weekly CP has similar outcomes to the InterAACT regimen. Nevertheless, pts who are HIV+ or have ECOG 2/3 had poor outcomes and other treatment strategies should be studied for these pts.

scholarly journals United States Pharmacopeia (USP) Safety Review of Gamma-Aminobutyric Acid (GABA)

Nutrients ◽  
2021 ◽  
Vol 13 (8) ◽  
pp. 2742
Author(s):  
Hellen A. Oketch-Rabah ◽  
Emily F. Madden ◽  
Amy L. Roe ◽  
Joseph M. Betz
Keyword(s):  
Blood Pressure ◽  
Adverse Events ◽  
Dietary Supplement ◽  
Clinical Studies ◽  
Case Reports ◽  
Endocrine System ◽  
Chronic Administration ◽  
Fermented Milk ◽  
Gamma Aminobutyric Acid ◽  
Serious Adverse Events

Gamma-amino butyric acid (GABA) is marketed in the U.S. as a dietary supplement. USP conducted a comprehensive safety evaluation of GABA by assessing clinical studies, adverse event information, and toxicology data. Clinical studies investigated the effect of pure GABA as a dietary supplement or as a natural constituent of fermented milk or soy matrices. Data showed no serious adverse events associated with GABA at intakes up to 18 g/d for 4 days and in longer studies at intakes of 120 mg/d for 12 weeks. Some studies showed that GABA was associated with a transient and moderate drop in blood pressure (<10% change). No studies were available on effects of GABA during pregnancy and lactation, and no case reports or spontaneous adverse events associated with GABA were found. Chronic administration of GABA to rats and dogs at doses up to 1 g/kg/day showed no signs of toxicity. Because some studies showed that GABA was associated with decreases in blood pressure, it is conceivable that concurrent use of GABA with anti-hypertensive medications could increase risk of hypotension. Caution is advised for pregnant and lactating women since GABA can affect neurotransmitters and the endocrine system, i.e., increases in growth hormone and prolactin levels.

scholarly journals Efficacy and Tolerability of Lacosamide in Lennox–Gastaut Syndrome: A Systematic Review and Meta-analysis

2022 ◽  
Author(s):  
Prateek Kumar Panda ◽  
Indar Kumar Sharawat ◽  
Lesa Dawman ◽  
Pragnya Panda ◽  
Ananthanarayanan Kasinathan ◽  
...  
Keyword(s):  
Systematic Review ◽  
Adverse Events ◽  
Seizure Frequency ◽  
Retrospective Studies ◽  
Case Reports ◽  
Random Effect ◽  
Random Effect Model ◽  
Case Series ◽  
Eligibility Criteria ◽  
Serious Adverse Events

Abstract Purpose Lennox–Gastaut syndrome (LGS) is one of the most difficult to treat childhood-onset epileptic encephalopathies. There is growing evidence that lacosamide is safe and efficacious in patients and adults with refractory epilepsy. However, the evidence regarding the efficacy of lacosamide in LGS is controversial so far. We aimed to evaluate the efficacy and tolerability of lacosamide in patients with LGS. Methods We conducted a systematic review on MEDLINE, EMBASE, COCHRANE CENTRAL, Google Scholar, and Web of Science, collating all available literature till July 31, 2020. The qualitative review included case reports, case series, and both controlled/uncontrolled trials as well as retrospective studies, but for determining pooled estimates, we only included studies with a sample size of 5 or more. The primary outcome was the efficacy of lacosamide in patients with LGS. Clinical variables related to efficacy and adverse events attributed to lacosamide were extracted from each publication. The pooled estimate of variables related to these parameters was performed using a random-effect model. Results Of the 68 items identified by the search, 14 were reviewed as full-text. Eleven articles including two prospective and six retrospective studies fulfilled eligibility criteria and described outcomes in 81 patients (42 adults, 39 children, 60% male, range—1.4–61 years). On average, 35.2%, 27.9%, 7.3%, and 29.4% patients had > 50% reduction, < 50% reduction, no change, and worsening of seizure frequency, respectively. Although 36% of patients had adverse events like somnolence, behavioral abnormalities including irritability, aggressiveness, nausea, tremor, memory problems, dizziness, gastrointestinal discomfort, vomiting, and weight loss, no serious adverse events were noted. Conclusion The evidence available in the current literature is not sufficient to support or refute the use of lacosamide in patients with LGS. Although it is one of the possible therapeutic options worth exploring in patients with LGS, caution is still necessary, as there are reports of worsening of seizure frequency in some patients.

scholarly journals Clinical features and therapeutic efficacy in patients with pulmonary multidrug-resistant cavitary tuberculosis at Russian penitentiary system

2008 ◽  
pp. 67-72
Author(s):  
A. S. Kononets ◽  
S. G. Safonova ◽  
S. V. Sidorova ◽  
N. E. Khoroshilova ◽  
L. I. Golubeva ◽  
...  
Keyword(s):  
Adverse Events ◽  
Pulmonary Tuberculosis ◽  
Wide Spectrum ◽  
Treatment Strategies ◽  
Multidrug Resistant ◽  
High Rate ◽  
Serious Adverse Events ◽  
Chemotherapeutic Regimen ◽  
Surgical Interventions ◽  
Additional Resistance

The aim of this study was to analyze the course of the disease and efficacy of treatment of pulmonary multidrugresistant (MDR) cavitary tubercu losis in antituberculosis settings of Russian penitentiary system. Drug resistant was studied using the method of absolute concentrations. Among 190 males with MBTpositive cavitary pulmonary tuberculosis followedup in antituberculosis hospitals of Russian penitentiary system in Voronezh in 2003–2006, 79 patients (41.6 ± 3.4 %) were yielded MDR strains resistant to the firstline antimucobacterial drugs and 111 patients (58,4 ± 3,4 %) had strains resistant both to the firstline and the secondline drugs (isoniazid and rifampicin). Moreover, MBT strains resistant to cycloserine and quinolones were found in patients who have not been previously treated with these drugs. Both newly diagnosed patients with pulmonary tubercu losis and those with recurrent cavitary pulmonary tuberculosis had a high rate of primary and secondary MDR to the firstline and the secondline antimicobacterial drugs. Administration of I and IIA chemotherapeutic regimens in these patients resulted in occurrence of additional resistance to a wide spectrum of the firstline and the secondline antibiotics. Patients with chronic pulmonary tuberculosis are at high risk of MDR to combi nations of the firstline and the secondline drugs and need other treatment strategies including surgical interventions. Tuberculosis patients with MDR to combinations of the firstline and the secondline drugs were characterized by more severe chronic course of the disease with extended lesions and large cavities in the lungs. Adverse events to the secondline drugs were seen in 42.6 % of the patients with cavitary tuberculosis. Of them, serious adverse events requiring cancellation of the drug and change in chemotherapeutic regimen were noted in 17.9 % of cases.

scholarly journals Rectal perforations caused by cleansing enemas in chronically constipated patients: Two case reports

2020 ◽  
Vol 8 ◽  
pp. 2050313X2093825
Author(s):  
Seokyoun Lee ◽  
Jungnam Kwon ◽  
Junhee Lee
Keyword(s):  
Adverse Events ◽  
Elderly Patients ◽  
General Condition ◽  
Case Reports ◽  
Adverse Outcomes ◽  
Common Disease ◽  
Poor General Condition ◽  
Rectal Perforation ◽  
Serious Adverse Events ◽  
Generalized Peritonitis

Constipation is a common disease that is frequently treated with cleansing enemas. Enemas are considered as effective and in some cases may cause serious adverse events. Iatrogenic perforations due to enemas lead to adverse outcomes in elderly patients with a poor general condition. Perforation remains an infrequent and rarely reported complication. In this work, we describe the cases of two patients with rectal perforation caused by a cleansing enema. The first patient had rectal perforation that led to a para-rectal abscess and the second patient had generalized peritonitis caused by rectal perforation.

A Cumulative Review of the Range and Incidence of Significant Adverse Events Associated with Acupuncture

2004 ◽  
Vol 22 (3) ◽  
pp. 122-133 ◽  
Author(s):  
Adrian White
Keyword(s):  
Adverse Events ◽  
Case Reports ◽  
Central Nervous System Infection ◽  
Auricular Acupuncture ◽  
External Ear ◽  
Serious Adverse Events ◽  
Medical Treatments ◽  
Serious Adverse Event ◽  
The Central Nervous System ◽  
Common Infection

Objective To summarise the range and frequency of significant adverse events associated with acupuncture in order to provide evidence on which to base continuing efforts to improve the safety of acupuncture practice. Methods Searches were conducted of computerised databases, previous reviews of case reports, population surveys, prospective surveys of acupuncture practice and relevant sections of textbooks for primary and secondary reports to indicate the range of significant adverse events associated with acupuncture. Data from prospective surveys of acupuncture were combined to estimate the incidence of serious adverse events. Results A total of 715 adverse events was included. There were 90 primary reports of trauma, and 186 secondary reports; the most common were pneumothorax and injury to the central nervous system. Infection accounted for 204 primary reports and 91 secondary reports. Over 60% of these cases were hepatitis B. The next most common infection was of the external ear, as a complication of auricular acupuncture. The 144 miscellaneous events mainly comprised seizures and drowsiness judged severe enough to cause a traffic hazard. There were 12 primary reports of deaths. According to the evidence from 12 prospective studies which surveyed more than a million treatments, the risk of a serious adverse event with acupuncture is estimated to be 0.05 per 10 000 treatments, and 0.55 per 10 000 individual patients. Conclusions The risk of serious events occurring in association with acupuncture is very low, below that of many common medical treatments. The range of adverse events reported is wide and some events, specifically trauma and some episodes of infection, are likely to be avoidable.

scholarly journals Safety of Acupuncture Practice in Japan: Patient Reactions, Therapist Negligence and Error Reduction Strategies

2008 ◽  
Vol 5 (4) ◽  
pp. 391-398 ◽  
Author(s):  
Hitoshi Yamashita ◽  
Hiroshi Tsukayama
Keyword(s):  
Adverse Events ◽  
Clinical Training ◽  
Adverse Reactions ◽  
Case Reports ◽  
Feedback System ◽  
Minor Bleeding ◽  
Serious Adverse Events ◽  
Continued Education ◽  
Reduction Strategies ◽  
Almost All

Evidence-based approach on the safety of acupuncture had been lagging behind both in the West and the East, but reliable data based on some prospective surveys were published after the late 1990s. In the present article, we, focusing on ‘Japanese acupuncture’, review relevant case reports and prospective surveys on adverse events in Japan, assess the safety of acupuncture practice in this country, and suggest a strategy for reducing the therapists’ error. Based on the prospective surveys, it seems reasonable to suppose that serious adverse events are rare in standard practice by adequately trained acupuncturists, regardless of countries or modes of practice. Almost all of adverse reactions commonly seen in acupuncture practice—such as fatigue, drowsiness, aggravation, minor bleeding, pain on insertion and subcutaneous hemorrhage—are mild and transient, although we should be cautious of secondary injury following drowsiness and needle fainting. After demonstrating that acupuncture is inherently safe, we have been focusing on how to reduce the risk of negligence in Japan, as well as educating acupuncturists more about safe depth of insertion and infection control. Incident reporting and feedback system is a useful strategy for reducing therapist errors such as forgotten needles. For the benefit of acupuncture patients in Japan, it is important to establish mandatory postgraduate clinical training and continued education system.

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