scholarly journals Assessment of causality and severity of various reported adverse drug reactions by different classes of anti-cancer drugs

Author(s):  
Shaheena Rasool ◽  
Masarat Nazeer ◽  
Mehwish Majeed

Background: Chemotherapy involves highly complex regimens and hence accounts to high susceptibility towards Adverse Drug Reactions. All antineoplastic drugs have potential to cause one or more Adverse Drug Reactions which may vary from mild to severe form. So the aim of this study was to determine the prevalence of Adverse Drug Reactions in patients treated with chemotherapy.Methods: After getting approval from the Institutional Ethical Committee, the prospective observational study was conducted in the Department of Pharmacology in association with Department of Radiation Oncology and Department of Medicine, Government Medical College, Srinagar between April 2015 to October 2016. All patients of either sex and any age receiving anti-cancer drugs in the inpatient department of radiation oncology were included. The mean age of the study population was 51 years and 53.9% of them were males and 46.1% of them were females. The WHO-UMC system was used for assessment of case programme and case reports. The severity of adverse drug reactions was determined by using modified Hart wig and Siegel scale.Results: Most of the reported ADR’s were moderate to mild in severity according to modified Hart wig and Siegel scale. Most of the frequent ADR’s were certain followed by probable and possible according to WHO-UMC causality assessment.Conclusions: Antineoplastic drugs have a narrow therapeutic index and the dosage needed to achieve a therapeutic response usually proves toxic to the body’s rapidly proliferating cells. Measures need to be put into place to reduce the physical, emotional and economic burden on the patient due to adverse drug reactions. Therefore, there is a need for vigilant ADR monitoring to decrease morbidity and mortality due to ADR’s which require further studies on large populations.

Author(s):  
N.V Rajeshkumar ◽  
Shinichi Yabuuchi ◽  
Shweta G. Pai ◽  
Anirban Maitra ◽  
Manuel Hidalgo ◽  
...  

AbstractGuided by the principle of primum non nocere (first do no harm), we report a cautionary note on the potential fatal toxicity of chloroquine (CQ) or hydroxychloroquine (HCQ) in combination with anti-diabetic drug metformin. We observed that the combination of CQ or HCQ and metformin, which were used in our studies as potential anti-cancer drugs, killed 30-40% of mice. While our observations in mice may not translate to toxicity in humans, the reports that CQ or HCQ has anti-COVID-19 activity, the use of CQ resulting in toxicity and at least one death, and the recent Emergency Use Authorization (EUA) for CQ and HCQ by the US Food and Drug Administration (FDA) prompted our report. Here we report the lethality of CQ or HCQ in combination with metformin as a warning of its potential serious clinical toxicity. We hope that our report will be helpful to stimulate pharmacovigilance and monitoring of adverse drug reactions with the use of CQ or HCQ, particularly in combination with metformin.


2016 ◽  
Vol 11 (1) ◽  
pp. 104-108 ◽  
Author(s):  
Luca Gallelli ◽  
Giuseppe Gallelli ◽  
Giuseppe Codamo ◽  
Angela Argentieri ◽  
Andzelika Michniewicz ◽  
...  

2020 ◽  
Vol 11 ◽  
pp. 204209862092248
Author(s):  
Sunil Shrestha ◽  
Krisha Danekhu ◽  
Bhuvan KC ◽  
Subish Palaian ◽  
Mohamed Izham Mohamed Ibrahim

Background: Bibliometric analyses have been used previously to study the measures of quality and impact of research performed in several health-related areas such as adverse drug reactions (ADRs) and pharmacovigilance (PV), etc. This method can assess the research performance of publications quantitatively and statistically. There is no evidence of bibilometric studies analyzing ADRs and PV from Nepal. Therefore, the present study aimed to assess scientific output on ADRs and PV-related research activities in Nepal using a bibliometric analysis of publications from 2004 January to December 2018, that is, 15 years. Methods: A systematic search was conducted in PubMed, Web of Science, Google Scholar, Scopus and Nepal Journal Online (NepJOL) databases. ‘Adverse Drug Reactions‘ or ‘ADRs‘ or ‘ADR‘ or ‘Adverse drug reaction‘ or ‘AE‘ or ‘Adverse Event‘ or ‘Drug-Induced Reaction‘ or ‘Pharmacovigilance‘ or ‘PV‘ and ‘Nepal‘. The search covered 15 years (January 2004 to December 2018) of study on ADRs and PV in Nepal. Only articles retrieved from databases were included, whereas published/unpublished drug bulletins, pharmacy newsletters and thesis were excluded. The articles thus retrieved were recorded, and thereafter analyzed. Word count code was used for the analysis of keywords used in the retrieved articles. Results: A total of 124 articles were retrieved, with the highest rate of publications in 2006 and 2007, with 16 papers each. Among the articles, 10 (8.1%) were published in Kathmandu University Medical Journal (KUMJ). Single papers were published in 38 different journals. Brief reports (1.6%), case reports (31.2%), case series (0.8%), education forums (0.8%), letters to the editor (5.6%), original research articles (41.9%), review articles (9.7%), short communications and short reports (8.1%) on ADRs and PV were recorded. Out of 124 papers, 52 (41.9%) were original research publications. The majority (74.1%) of research was done in the category of ADR incidence, types, prevention, and management, followed by policy and suggestions for strengthening national and regional pharmacovigilance centers of Nepal (14.5%). Conclusions: During the study years, there was an increase in scientific publications on drug safety. A total of 124 published articles were found during bibliometric analysis of ADRs and PV research activities in Nepal.


Author(s):  
Jaime A. Soto ◽  
María Isabel Méndez ◽  
Jonathan D. Berman

We present case reports of two patients treated with miltefosine for mucocutaneous leishmaniasis whose gastrointestinal symptoms were initially diagnosed as a drug reaction and only later recognized as due to COVID-19. Gastrointestinal symptoms of COVID-19 are unusual, whereas gastrointestinal adverse drug reactions are very common. These reports exemplify that this infrequent presentation of COVID-19 is likely to be ascribed to a more common etiology such as a gastrointestinal drug reaction.


2004 ◽  
Vol 15 (4) ◽  
pp. 221-239 ◽  
Author(s):  
C. Scully ◽  
J.-V. Bagan

A wide spectrum of drugs can sometimes give rise to numerous adverse orofacial manifestations, particularly dry mouth, taste disturbances, oral mucosal ulceration, and/or gingival swelling. There are few relevant randomized double-blind controlled studies in this field, and therefore this paper reviews the data from case reports, small series, and non-peer-reviewed reports of adverse drug reactions affecting the orofacial region (available from a MEDLINE search to April, 2003). The more common and significant adverse orofacial consequences of drug therapy are discussed.


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