scholarly journals Evaluation of completeness of adverse drug reaction case reports published in biomedical Journals: A preliminary analysis

2018 ◽  
Vol 4 (2) ◽  
pp. 98-101
Author(s):  
Jitendra Hotwani ◽  
◽  
Disha Rambhia ◽  
Manthan Mehta ◽  
◽  
...  
Keyword(s):  
Adverse Drug Reaction ◽  
Drug Reaction ◽  
Preliminary Analysis ◽  
Case Reports ◽  
Biomedical Journals

scholarly journals Amoxicillin Induced Steven Johnson’s Syndrome: A Case Report

2020 ◽  
Vol 10 (4-s) ◽  
pp. 220-222
Author(s):  
R Mahendra Kumar ◽  
Sanatkumar Nyamagoud ◽  
Krishna Deshpande ◽  
Ankitha Kotian
Keyword(s):  
Adverse Drug Reaction ◽  
Drug Reaction ◽  
Case Reports ◽  
The Body ◽  
Stevens Johnson Syndrome ◽  
Hypersensitivity Reactions ◽  
Johnson Syndrome ◽  
Oral Consumption ◽  
Life Threatening

Stevens-Johnson syndrome (SJS) is a very rare, potentially fatal skin reaction that is typically the result of reaction to the drug. In particular, SJS is characterized by extensive skin and mucous membrane lesions (i.e. mouth, nose, esophagus, anus, and genitalia), epidermis detachment, and acute skin blisters. In 95 % of case reports, drugs were found to be an important cause for the development of SJS. This story is a case of A 42 year old male hospitalized with rashes all over the body and fever, after oral consumption of Amoxicillin drug for sore throat. This case study discusses the possibility that serious hypersensitivity reactions with Amoxicillin can rarely occur and can be extremely harmful and life-threatening Menacing. Keywords: Toxic Epidermal Necrolysis, Stevens Johnson Syndrome, Adverse drug reaction, Nikolsky’s sign

Capecitabine-induced myopericarditis – A case report and review of literature

2018 ◽  
Vol 25 (4) ◽  
pp. 1006-1010 ◽  
Author(s):  
Sydney Saunders ◽  
Maria Anwar
Keyword(s):  
Adverse Drug Reaction ◽  
Drug Reaction ◽  
Case Report ◽  
Literature Search ◽  
Case Reports ◽  
Locally Advanced ◽  
Rectal Adenocarcinoma ◽  
Review Of Literature ◽  
Medication Discontinuation ◽  
Laboratory Investigations

Objective To describe a possible case of capecitabine-induced myopericarditis in a patient at the Cardio-Oncology Clinic in Calgary, AB. Design A literature search and adverse drug reaction assessment with the Naranjo tool was conducted. Results A 39-year-old male with recurrent locally advanced rectal adenocarcinoma presented two days after adjuvant treatment with capecitabine and oxaliplatin complaining of intermittent, severe interscapular pain. Based on symptoms, laboratory investigations, and imaging, the patient was diagnosed with acute myopericarditis. Management included aspirin, colchicine, and discontinuing adjuvant chemotherapy. A literature review revealed one case report of capecitabine-induced myopericarditis; however, more data were found regarding the cardiotoxicity of fluorouracil, for which capecitabine is a pro-drug. No case reports were found for oxaliplatin. Conclusion Due to the timeline of capecitabine administration, symptom onset, and improvement upon medication discontinuation, capecitabine is the probable cause of the myopericarditis. Although rare, it is important to consider the possibility of myopericarditis in patients receiving a fluoropyrimidine who present with cardiovascular symptoms.

SELF-REPORTED ALLERGY TO THYROID REPLACEMENT THERAPY: A MULTICENTER RETROSPECTIVE CHART REVIEW

2020 ◽  
Vol 26 (7) ◽  
pp. 761-767
Author(s):  
Natalia Chamorro-Pareja ◽  
Ismael Carrillo-Martin ◽  
Daniela A. Haehn ◽  
Sydney A. Westphal ◽  
Miguel A. Park ◽  
...  
Keyword(s):  
Adverse Drug Reaction ◽  
Drug Reaction ◽  
Replacement Therapy ◽  
Chart Review ◽  
Case Reports ◽  
Drug Hypersensitivity ◽  
Retrospective Chart Review ◽  
The United States ◽  
Autoimmune Hypothyroidism ◽  
Drug Hypersensitivity Reaction

Objective: To determine patterns of adverse drug reactions (ADRs), including immediate drug hypersensitivity reactions (DHRs) and predictable ADRs, to thyroid replacement therapy (TRT). TRT is the treatment of choice for hypothyroidism. Levothyroxine (LT4) is among the most commonly prescribed medications in the United States, with over 70 million prescriptions annually. Documented immediate DHRs to TRT are rare, with only a few case reports. Methods: An 11-year (2008–2018) retrospective medical chart review of identified patients with self-reported allergy to TRT. ADRs to TRT were divided into immediate DHRs and predictable ADRs. Results: A total of 466 patients were included in our study. We found an overall incidence of ADRs to TRT of 0.3%. Median age was 61.2 years; 85.8% were women, and 94.4% were Caucasian. The principal indication for TRT was autoimmune hypothyroidism (73.6%), followed by postsurgical hypothyroidism (17.4%) and subclinical hypothyroidism (6.7%). Predictable ADR manifestations to TRT were reported more commonly than DHR manifestations (57.5% vs. 42.5%, respectively). The most frequently reported of the former were palpitations (16.4%), nausea/vomiting (9.3%), and tremor (6.3%), while rash (23.8%), hives (9.5%), and pruritus (7.1%) were the most common regarding the latter. Fifty-six percent of the patients with an ADR to TRT tolerated an alternative TRT presentation. Conclusion: In our cohort, the majority of self-reported allergies to TRT were due to predictable ADRs rather than an immediate DHR. Abbreviations: ADR = adverse drug reaction; DHR = drug hypersensitivity reaction; FDA = Food and Drug Administration; LT3 = liothyronine; LT4 = levothyroxine; SCAR = severe cutaneous adverse drug reaction; TRT = thyroid replacement therapy

Evaluation of the Reproducibility of the Naranjo Adverse Drug Reaction Probability Scale Score in Published Case Reports

2014 ◽  
Vol 34 (11) ◽  
pp. 1159-1166 ◽  
Author(s):  
Ruby Liang ◽  
Bjug Borgundvaag ◽  
Mark McIntyre ◽  
Crystal Thwaites ◽  
Kelsey Ragan ◽  
...  
Keyword(s):  
Adverse Drug Reaction ◽  
Drug Reaction ◽  
Scale Score ◽  
Case Reports ◽  
Reaction Probability ◽  
Probability Scale

Ten years of adverse drug reaction reports for the multiple sclerosis immunomodulatory therapies: a Canadian perspective

2008 ◽  
Vol 14 (1) ◽  
pp. 94-105 ◽  
Author(s):  
H.L. Tremlett ◽  
J. Oger
Keyword(s):  
Multiple Sclerosis ◽  
Adverse Drug Reaction ◽  
Drug Reaction ◽  
Case Reports ◽  
Monitoring Program ◽  
The Elderly ◽  
Adr Reporting ◽  
Post Marketing Surveillance ◽  
Post Marketing ◽  
Drug Withdrawals

Adverse drug reaction (ADR) reporting is essential in the post-marketing surveillance of drugs, detection of serious adverse reactions, and has been the basis for drug withdrawals. The study aimed to examine ADR reporting patterns to the multiple sclerosis (MS) immunomodulatory drugs (IMD) in Canada. All ADRs reported to the Canadian ADR Monitoring Program (CADRMP) from 1965 to March 2006 ( n = 193 208) were accessed and ADRs in which an IMD for MS (beta-interferon or glatiramer acetate) was the suspected drug extracted ( n = 888 reports were dated March/96—March/06). Almost half of all IMD ADRs reports (438/888) were sourced through the patient compared to 14.9% (10 649/71 373) of all ADRs reported to CADRMP over the same period. Of IMD ADR reports, 88.7% (788/888) were directed through the manufacturer compared to 57.7% (41197/71373) of all ADRs. Encouragement to others involved in patient care, such as pharmacists, nurses and physicians might enhance reporting of MS ADRs. Despite the limitations of ADR reporting data, previously unpublished case reports in several understudied MS populations were detailed: paediatrics (≤16 years old, n = 4), the elderly (≥65 years, n = 23) and during pregnancy ( n = 12). In addition, 46 deaths suspected by the reporter as being related to IMD treatment were detailed as well as three possible drug interactions. Multiple Sclerosis 2008; 14: 94—105. http://msj.sagepub.com

Adr In Journals: Are They Translated Into Regulatory Frameworks?

2021 ◽  
Vol 16 ◽  
Author(s):  
Annapurna Kolupoti ◽  
Ananya Chakraborty ◽  
Shahistha K
Keyword(s):  
Adverse Drug Reaction ◽  
Drug Reaction ◽  
Case Reports ◽  
Package Insert ◽  
Geographic Location ◽  
Scientific Publication ◽  
Geographic Region ◽  
Package Inserts ◽  
Regulatory Authorities ◽  
The Uk

Introduction: An adverse drug reaction case report refers to a scientific publication that is written by a health care professional who suspects a causal relationship between a drug and an adverse drug reaction (ADR). ADR case reports help to identify potential risks associated with the use of the drug. Most of the case reports do not mention reporting the ADR to regulatory authorities. With this objective, the aim of this study was to analyze the number of Adverse Drug Reaction (ADR) published as case reports (PubMed indexed journals) from January 2018 to June 2019 and observe if they are translated into a regulatory framework like Vigibase and package inserts. Materials And Methods: 321 ADRs were obtained with the keywords “Adverse Drug Reaction.” Out of those, 158 were independently extracted by two investigators, observed and categorized according to classes of the drugs, geographic location, severity, hospitalization, completeness of ADR, and whether they were reported to the regulatory authority (VigiBase) or listed in the package insert. Literature review articles were excluded. Results: Out of the 158 ADRs, antibiotics accounted for 12.65%, CNS drugs and monoclonal antibodies accounted for 11.39%, anticancer drugs for 9.49%, CVS drugs for 4.43%, anti-virals for 3.79%, and the others for 45.56%. According to geographic region, 26 ADRs published were from USA, 4 from Australia, 3 from Italy, 17 from India, 9 from Turkey, 1 from Singapore and the UK, 20 from China, 2 from Denmark and Canada, 10 from Japan, 9 from France, 1 from Austria, 5 from Korea, 3 from South America, and 2 from Switzerland. Depending upon the severity, causality assessment was performed for 45 ADRs only; it was not performed for 113 ADRs. 41.13% of patients (from 65 case reports) were hospitalized. Among the 158 ADRs, 14 ADRs were not found in VigiBase. 32 ADRs were not mentioned in the drug package inserts. When categorized according to the completeness of case reports, weight accounted for 1.89%, lab values and procedure for diagnosis accounted for 96.8%, risk factors for 95.56%, prior exposure for 88.60%, post ADR status for 60.12%, and the start-stop medication, route of administration, first dose, last dose, and the duration of illness accounted for 100%. Conclusion: Depending upon our observation, we have noticed that there is a deficiency in reporting of suspected ADR to the regulatory authorities. Reporting can be included as mandatory criteria for ADR case reports. Also, there is an increased need for various healthcare workers to be aware about reporting ADR.

scholarly journals Tramadol-induced hiccups: a case–noncase study in the European pharmacovigilance database

2021 ◽  
Vol 12 ◽  
pp. 204209862110212
Author(s):  
Montserrat García ◽  
Unax Lertxundi ◽  
Carmelo Aguirre
Keyword(s):  
Adverse Drug Reaction ◽  
Drug Reaction ◽  
World Health Organization ◽  
Case Reports ◽  
Opioid Analgesic ◽  
World Health ◽  
Plain Language ◽  
The World ◽  
Pharmacovigilance Database ◽  
Health Organization

Background: Hiccups are usually benign and self-limiting, but can sometimes be persistent. If left untreated, they can provoke severe discomfort, and even death. Hiccups can be idiopathic, organic, psychogenic, and caused by drugs. Although some case reports have suggested a possible association between tramadol and hiccups, to our knowledge, no study has analyzed this possible relationship. The aim of this study was to analyze whether a disproportionate number of cases of hiccups are reported for tramadol in the EudraVigilance database. Methods: A case–noncase study was conducted to assess the association between hiccups and tramadol, calculating reporting odds ratios (RORs) from 1 January 1995 to 11 September 2020. Cases were selected using the preferred term ‘Hiccups’. The noncases used as controls were all other adverse drug reaction reports recorded in EudraVigilance during the same period. Exposure was defined as exposure to tramadol among cases and noncases. To reduce the risk of confounding by indication, the RORs for tramadol compared with other opioids were obtained. Additionally, we performed a confirmatory analysis in the World Health Organization pharmacovigilance database, VigiBase®. Results: There were 3089 cases of hiccups in the 7,213,623 reports. Tramadol was involved in 50 cases. The ROR for tramadol exposure was 3.35 [95% confidence interval (CI) 2.53–4.43]. This association persisted when comparing tramadol with other opioids; ROR: 2.13 (95% CI 1.52–2.99). Disproportionality was also observed in VigiBase®: ROR 1.69 (95% CI 1.47–1.93). Conclusion: Our study confirms, for the first time, a possible signal for a tramadol–hiccups association. Nevertheless, observational analytical studies are needed to confirm these results Plain Language Summary Evaluation of the relationship between the tramadol and the risk of hiccups Introduction: Hiccups are sudden involuntary contractions of the diaphragm. This involuntary contraction causes the vocal cords to close very briefly, which produces the characteristic sound of a hiccup. Hiccups are usually benign and self-limiting, but can sometimes be persistent. If left untreated, they can provoke severe discomfort, depression, disability, and in the most extreme cases, even death. Drugs are a rare cause of hiccups. Methods: This study investigated the possible association between tramadol and hiccups (an unmentioned adverse drug reaction in the Summary of Product Characteristics) in the European pharmacovigilance database (EudraVigilance) and a confirming analysis in the World Health Organization pharmacovigilance database (VigiBase). Results: Our analysis shows that hiccups is relatively more frequently reported in association with tramadol than with other medicinal products, with EudraVigilance and VigiBase confirming this association. Conclusion: Tramadol is an opioid analgesic indicated, alone or in combination with dexketoprofen or paracetamol for pain with various causes, so healthcare professionals and patients should be aware of this possible association.

A Case Report of Tadalafil-Associated Fixed Drug Eruption

2017 ◽  
Vol 31 (6) ◽  
pp. 678-681 ◽  
Author(s):  
Ada W. Chiu ◽  
Robert Stenstrom
Keyword(s):  
Adverse Drug Reaction ◽  
Drug Reaction ◽  
Case Report ◽  
Drug Eruption ◽  
Case Reports ◽  
Good Evidence ◽  
Medical Attention ◽  
Medication History ◽  
Fixed Drug Eruption ◽  
Fixed Drug

Tadalafil is a drug approved for use in erectile dysfunction, but increasingly being used recreationally. There have only been scant case reports on tadalafil causing fixed drug eruption (FDE). Patients who use tadalafil recreationally are less likely to seek medical attention and the diagnosis can often be missed, given the difficulty in diagnosis. However, clinical examination together with a detailed medication history can provide clinicians with good evidence of the association without invasive biopsies. We discuss a 37-year-old male who developed FDE after 2 separate exposures to tadalafil used for recreational purpose. The scar from the first reaction served as a landmark for the second exposure. His lesions resolved 2 days after the initial presentation. The Naranjo adverse drug reaction probability scale (score = 9) indicates a definite adverse drug reaction to tadalafil. We hope to raise awareness of this drug reaction with this case report.

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