Adverse drug reactions and adverse events of 33 varieties of traditional Chinese medicine injections on National Essential medicines List (2004 edition) of China: an overview on published literatures

PURPOSE: Our working hypothesis is that bioactive phytochemicals that are important constituents of Traditional Chinese Medicine and their defined mixtures have potential as complementary therapy for chemoprotection against adverse drug reactions whose toxicity is not related to the pharmacological action of the drug but where oxidative and nitrosative stress are causative factors. METHODS: In this investigation we measured cytotoxicity, lipid peroxidation, protein carbonylation and ROS/NOS-mediated changes in the disulfide proteome of Jurkat E6.1 cells resulting from exposure to sulfamethoxazole N-hydroxylamine with or without pre-treatment with low µM concentrations of baicalein, crocetin, resveratrol and schisanhenol alone and in defined mixtures to compare the ability of these treatment regimens to protect against ROS/RNS toxicity to Jurkat E6.1 cells in culture. RESULTS: Each of the Traditional Chinese Medicine constituents and defined mixtures tested had significant chemoprotective effects against the toxicity of ROS/RNS formed by exposure of Jurkat E6.1 cells to reactive metabolites of sulfamethoxazole implicated as the causative factors in adverse drug reactions to sulfa drugs used for therapy. At equimolar concentrations, the defined mixtures tended to be more effective chemoprotectants overall than any of the single constituents against ROS/RNs toxicity in this context. CONCLUSIONS: At low µM concentrations, defined mixtures of TCM constituents that contain ingredients with varied structures and multiple mechanisms for chemoprotection have excellent potential for complementary therapy with sulfa drugs to attenuate adverse effects caused by oxidative/nitrosative stress. Typically, such mixtures will have a combination of immediate activity due to short in vivo half-lives of some ingredients cleared rapidly following metabolism by phase 2 conjugation enzymes; and some ingredients with more prolonged half-lives and activity reliant on phase 1 oxidation enzymes for their metabolic clearance. This article is open to POST-PUBLICATION REVIEW. Registered readers (see “For Readers”) may comment by clicking on ABSTRACT on the issue’s contents page.

Download Full-text

Management of Chinese Pharmacists Carrying out Pharmaceutical Care to Reduce Adverse Drug Reactions of Traditional Chinese Medicine

10.47939/mh.v2i12.233 ◽

2012 ◽

Keyword(s):

Chinese Medicine ◽

Traditional Chinese Medicine ◽

Pharmaceutical Care ◽

Adverse Drug Reactions ◽

Drug Reactions

Download Full-text

Development of a Core Outcome Set for the Benefits and Adverse Events of Acute Heart Failure in Clinical Trials of Traditional Chinese Medicine and Western Medicine: A Study Protocol

Frontiers in Medicine ◽

10.3389/fmed.2021.677068 ◽

2021 ◽

Vol 8 ◽

Author(s):

Ruijin Qiu ◽

Songjie Han ◽

Xuxu Wei ◽

Changming Zhong ◽

Min Li ◽

...

Keyword(s):

Heart Failure ◽

Clinical Trials ◽

Chinese Medicine ◽

Traditional Chinese Medicine ◽

Adverse Events ◽

Health Professionals ◽

Core Outcome Set ◽

Essential Medicines ◽

Core Outcome ◽

Outcome Set

Aims: To identify a minimum set of efficacy and adverse events for patients with acute heart failure (AHF) among different stakeholders in clinical trials of traditional Chinese medicine and Western medicine.Methods and Analysis: First, we will develop a preliminary long list of outcomes that includes efficacy and adverse events/reactions via three steps: (i) systematic reviews of efficacy and safety outcomes for clinical trials of AHF; (ii) drugs included in the National Medical Insurance Catalog, the National Essential Medicines Catalog, and the WHO Essential Medicines List will be collected and safety outcomes extracted from the package inserts; and (iii) patients' or caregivers' semi-structured interviews will be carried out to add new viewpoints to the list. Second, after merging outcomes and grouping them under different outcome domains, questionnaires for health professionals and patients will be separately developed. Further, two rounds of Delphi survey for health professionals and a survey for patients and the public will be carried out. Third, different stakeholders will discuss and determine the final core outcome set (COS) for AHF in a consensus meeting.Ethics and Dissemination: The entire project has been approved by the Ethics Committee of the main institution. After the final COS is developed, it will be published and discussed widely in conferences.Clinical Trial Registration: This study is registered with the Core Outcome Measures in Effectiveness Trials database as study 1566 (available at: https://www.cometinitiative.org/Studies/Details/1566).

Download Full-text

Improving reporting of adverse events and adverse drug reactions following injections of Chinese materia medica

Journal of Evidence-Based Medicine ◽

10.1111/j.1756-5391.2010.01055.x ◽

2010 ◽

Vol 3 (1) ◽

pp. 5-10 ◽

Cited By ~ 12

Author(s):

Zhao-Xiang Bian ◽

Hao-Yao Tian ◽

Lin Gao ◽

Hong-Cai Shang ◽

Tai-Xiang Wu ◽

...

Keyword(s):

Adverse Events ◽

Adverse Drug Reactions ◽

Drug Reactions ◽

Chinese Materia Medica ◽

Materia Medica

Download Full-text

Major Aspects of Detection and Monitoring of Adverse Reactions Associated with Cephalosporin Antibiotic Treatment

Safety and Risk of Pharmacotherapy ◽

10.30895/2312-7821-2021-9-1-34-42 ◽

2021 ◽

Vol 9 (1) ◽

pp. 34-42

Author(s):

E. Yu. Demchenkova ◽

G. I. Gorodetskaya ◽

I. A. Mazerkina ◽

M. V. Zhuravleva ◽

A. S. Kazakov ◽

...

Keyword(s):

Adverse Events ◽

Adverse Drug Reactions ◽

Patient Information ◽

Adverse Reactions ◽

Stevens Johnson Syndrome ◽

Drug Reactions ◽

Patient Information Leaflets ◽

Information Leaflets ◽

Spontaneous Reports ◽

Cephalosporin Antibiotics

Widespread use of cephalosporin antibiotics in clinical practice calls for greater attention to the risk of adverse drug reactions. Information on serious or unexpected adverse events reported during post-marketing experience is submitted to national and international pharmacovigilance databases. Analysis of these reports helps to identify new adverse drug reactions.The aim of the study was to analyse the safety profile of cephalosporin antibiotics based on spontaneous reports in the international VigiBase database.Materials and methods: the analysis of the adverse reaction profile of cephalosporin antibiotics was based on MedDRA system organ classes and included spontaneous reports submitted to VigiBase from the moment of its creation until August 2020.Results: the authors identified the most clinically significant adverse reactions for different cephalosporin generations. They compared and analysed information on adverse events in VigiBase and in patient information leaflets of medicinal products authorised in the Russian Federation. It was demonstrated that some serious events described in VigiBase spontaneous reports for V-generation cephalosporins are not included in the “Side effects” section of the patient information leaflets. According to VigiBase, the use of ceftaroline was associated with the development of generalised exfoliative dermatitis, Stevens–Johnson syndrome, tubulointerstitial nephritis, while the use of ceftolozane was associated with acute kidney injury, renal insufficiency, sepsis, pneumonia, and respiratory insufficiency.Conclusion: reporting of unexpected and serious adverse drug reactions to cephalosporin antibiotics is an important task of healthcare practitioners. Availability of information on class-specific and generation-specific serious adverse reactions will help predict and prevent their development.

Download Full-text

NEUROPSYCHIATRIC ADVERSE EFFECTS OF ANTIBACTERIAL AGENTS

International Journal of Pharmacy and Pharmaceutical Sciences ◽

10.22159/ijpps.2021v13i12.42482 ◽

2021 ◽

pp. 1-8

Author(s):

SANTA TREASA CYRIAC ◽

DIVYA SARA IYPE

Keyword(s):

Adverse Effects ◽

Adverse Events ◽

Adverse Drug Reactions ◽

Bacterial Growth ◽

Antibacterial Agents ◽

Acute Psychosis ◽

Drug Reactions ◽

Medical Practitioners ◽

General Management ◽

Neuropsychiatric Adverse Effects

Anti-bacterial are agents that inhibit bacterial growth or kills bacteria and are a sub-type of antimicrobials. These are drugs used to treat infections, but they sometimes pose a threat of adverse events. Some of these adverse events are neuropsychiatric, which are generally hard to diagnose and is often paid less attention. They account for about 30% of total Adverse drug reactions (ADRs) caused by drugs in patients without mental abnormalities. The spectrum ranges from episodes of seizure to acute psychosis. The article emphasizes the frequency of such adverse events and means to raise awareness among medical practitioners regarding the same. The various neuropsychiatric adverse effects and the agents responsible have been reviewed, along with their possible mechanisms and general management. The information for writing this review was selected by searching for keywords such as Neurotoxicity, GABA, Psychosis, Naranjo scale, and Antibiomania in databases such as Google Scholar, PubMed, Elsevier, etc. After searching the articles in the above-mentioned databases, the articles were screened concerning their importance with our work and according to their title and abstract. Additional articles were discovered by checking the references in the current study's citations. Using this method, the various neuropsychiatric adverse effects of Antibacterial agents were summarized in this review.

Download Full-text