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 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 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 Procedural Pain and Serious Adverse Events with Bone Marrow Aspiration and Biopsy: Real World Experience from India

Blood ◽  
2020 ◽  
Vol 136 (Supplement 1) ◽  
pp. 38-38
Author(s):  
Chepsy C Philip ◽  
Inderjit Singh ◽  
Rachel Thaper ◽  
Alice David ◽  
Suvir Singh ◽  
...  
Keyword(s):  
Bone Marrow ◽  
Adverse Event ◽  
Adverse Events ◽  
Pain Perception ◽  
Bone Marrow Aspiration ◽  
Procedural Pain ◽  
Routine Practice ◽  
Serious Adverse Events ◽  
Serious Adverse Event ◽  
Factors Associated

Background: Bone Marrow aspiration and Biopsy (BMAB) is perceived by patients as a painful procedure with fearsome complications. Though informed as safe and well tolerated; there is limited data about the complications and degree of pain experienced by patients undergoing BMAB.[1] Further scarce is data from the developing world where procedural fear discourages patients from pursuing treatment and diagnosis.[2] Methods Aims: To estimate the level of pain and frequency of serious adverse eventsexperienced by patients undergoing BMAB at our center. We also attempted to identify factors associated with increased pain perception. Study setting: This study was conducted at a tertiary level teaching hospital, the Christian Medical College & Hospital, Ludhiana. Ethics approval was obtained from the Institutional research committee (CMC/1495). Study period: 01 April 2015 through 30 Nov 2019 Study Design: This is a comparative cross sectional study where comparison of those with relatively more pain to those with less was done to elicit the factors associated with pain perception. Study Population: All consecutive patients who underwent a BMAB and provided informed consent which was taken pre-procedure, were included. We excluded patients who underwent the procedure under general anesthesia. Logistics of the Study: The BMAB was performed variably by Consultant Physicians, Trainee Physicians and Physician Assistants. All patients were pre-medicated with tramadol intravenous pre-procedure, and the preferred approach was from the posterior superior iliac spine (PSIS) in a left lateral decubitus under local anesthesia with lignocain. Patients were sent home or returned to their ward after upto 60 minutes of observation. A serious adverse event was considered as one requiring a prolonged observation beyond routine practice or extending to an admission to manage adverse events following and related to the BMAB. Data sources and variables Information regarding age at diagnosis, address and sex, indication to perform the BMAB, coded as malignant and non-malignant was collected from each patient. Number of prior procedures and details regarding food intake were collected as recalled by the patient. Level of pain was noted soon after the BMAB using a combined Wong-Baker grimace with numeric pain scale by the patient themselves. Statistical Analysis: Descriptive statistics were used to characterize variables. Univariate and Multivariate Logistic Regression were used to identify factors associated with higher pain severity (Score >2). Results: A total of 942 BMAB procedures were performed in this period. Baseline characteristics as tabulated below (Table1). Although the Mean + SD pain score was only 2.7 + 1.39, fourteen patients (1.48%) reported severe pain (>8). The following risk-factors were associated with increased pain on multivariate analysis: those experiencing their first BMAB procedure had very low odds of pain (OR (95 % CI): 0.23 (0.15-0.37)). However, when more than one attempt of biopsy was made, the odds of pain was much higher (OR (95 % CI): 1.62 (1.29-2.05)). Food and drink intake prior to procedure was associated only at the univariate level. Those who did not take any food prior to procedure had very high odds of pain (odds ratio (OR) 1.81 (95 % CI 1.01-3.22)). However, those who took juice had very low odds (OR (95 % CI): 0.619 (0.43-0.90)). Nine (0.95%) serious adverse events were reported. There were no deaths. The major serious adverse event was hemorrhage resulting from pseudo-aneurysm of the posterior iliac artery, which comprised 2 of the 9 serious adverse events. Other serious adverse events included persistent vomiting and severe aching pain in the ipsilateral leg. Conclusions: In our analysis BMAB is associated with a low level of procedural pain and is safe. The pain perception was not influenced by the operator. Factors associated with decreased pain perception were first procedural BMAB experience and successful completion of the procedure in the first attempt. Having at least a snack or a juice pre-procedure could reduce pain perception. Serious adverse events are rare in our experience. Disclosures No relevant conflicts of interest to declare.

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 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.

scholarly journals QT changes of unforeseen implications and bedaquiline: an observational study

2020 ◽  
Author(s):  
Sandip Mukhopadhyay ◽  
Samya Dutta ◽  
Rupam Ta
Keyword(s):  
Adverse Events ◽  
Observational Study ◽  
Real World ◽  
Adverse Reactions ◽  
Serious Adverse Events ◽  
Serious Adverse Event ◽  
The Real ◽  
Baseline Values ◽  
Access Program

Background: Bedqauiline (BDQ) is a relatively new agent for multidrug (MDR) and extremely drug resistant (XDR) TB. It is important to look for cardiac safety and the bizarre adverse reactions after initiation of the drugs from the real world studies. Methods: An observational study was conducted on the institutionalized MDR and XDR patients under the conditional access program of BDQ in India. Daily ECG, adverse events and change in laboratory values for first two weeks were recorded with mortality and serious adverse events till first three months of initiation of BDQ containing regimen. Results: Among the total of 49 patients, nausea (n=33) was the most reported side effect. Though a mean rise of QTcF (12%) was noted after 14 days, individually, both prolongations (QTcF >440 ms) and shortening (from baseline values) of QTcF were noted in 95.92% (n=47) and 89.8% (n=44) patients. Three distinct QT patterns noted in ECG were, a) initial rise then fall (n=8), b) initial fall then rise (n=9) and c) rise followed by further rise (32). There was no serious adverse event leading to drug withdrawal or mortality in the first three months. Conclusions: Prolongation of QTcF occurs in alarming numbers during first two weeks of BDQ therapy as well as shortened QT. However, BDQ was otherwise tolerated well by the real world MDR & XDR-TB patients in short term. Intensive ECG and clinical monitoring is recommended to detect possible serious implications of such ECG changes in the long term.

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.

scholarly journals Serious adverse events and lifetime risk of reoperation after elective shoulder replacement: population based cohort study using hospital episode statistics for England

BMJ ◽  
2019 ◽  
pp. l298 ◽  
Author(s):  
Richard S Craig ◽  
Jennifer C E Lane ◽  
Andrew J Carr ◽  
Dominic Furniss ◽  
Gary S Collins ◽  
...  
Keyword(s):  
Adverse Events ◽  
Revision Surgery ◽  
Population Based ◽  
Hospital Episode Statistics ◽  
Lifetime Risk ◽  
Shoulder Replacement ◽  
Serious Adverse Events ◽  
Serious Adverse Event ◽  
Replacement Surgery ◽  
Post Surgery

AbstractObjectivesTo provide accurate risk estimates of serious adverse events after elective shoulder replacement surgery for arthritis, including age and sex specific estimates of the lifetime risk of revision surgery.DesignPopulation based cohort study.SettingHospital episode statistics for NHS England, including civil registration mortality data.Participants58 054 elective shoulder replacements in 51 895 adults (aged ≥50 years) between April 1998 and April 2017.Main outcome measuresThe lifetime risk of revision surgery, calculated using an actuarial life table approach and the cumulative probability method. Rates of serious adverse events at 30 and 90 days post-surgery: pulmonary embolism, myocardial infarction, lower respiratory tract infection, acute kidney injury, urinary tract infection, cerebrovascular events, and all cause death. Secondary outcome measures were the number of surgeries performed each year and Kaplan-Meier estimates of revision risk at 3, 5, 10, and 15 years.ResultsThe number of shoulder replacements performed each year increased 5.6-fold between 1998 and 2017. Lifetime risks of revision surgery ranged from 1 in 37 (2.7%, 95% confidence interval 2.6% to 2.8%) in women aged 85 years and older to 1 in 4 (23.6%, 23.2% to 24.0%) in men aged 55-59 years. The risks of revision were highest during the first five years after surgery. The risk of any serious adverse event at 30 days post-surgery was 1 in 28 (3.5%, 3.4% to 3.7%), and at 90 days post-surgery was 1 in 22 (4.6%, 4.4% to 4.8%). At 30 days, the relative risk of pulmonary embolism compared with baseline population risk was 61 (95% confidence interval 50 to 73) for women aged 50-64. Serious adverse events were associated with increasing age, comorbidity, and male sex. 1 in 5 (21.2%, 17.9% to 25.1%) men aged 85 years and older experienced at least one serious adverse event within 90 days.ConclusionsYounger patients, particularly men, need to be aware of a higher likelihood of early failure of shoulder replacement and the need for further and more complex revision replacement surgery. All patients should be counselled about the risks of serious adverse events. These risks are higher than previously considered, and for some could outweigh any potential benefits. Our findings caution against unchecked expansion of shoulder replacement surgery in both younger and older patients. The more accurate age and sex specific estimates of risk from this study are long overdue and should improve shared decision making between patients and clinicians.Study registrationClinicalTrials.govNCT03573765.

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