Consequences to Patients, Clinicians, and Manufacturers When Titanic Adverse Drug Reactions are Identified (1997- 2019): A Report from the Southern Network on Adverse Reactions (SONAR)

2020 ◽  
Author(s):  
Charles L. Bennett ◽  
Shamia Hoque ◽  
David Aboulafia ◽  
Courtney Lubaczewski ◽  
Andrew C. Bennett ◽  
...  
Keyword(s):  
Adverse Drug Reactions ◽  
Adverse Reactions ◽  
Drug Reactions

Adverse Drug Reactions to Radiographic Contrast Media in a Teaching Hospital in North India: An Observational Study

2019 ◽  
Vol 14 (2) ◽  
pp. 122-126
Author(s):  
Deepti Chopra ◽  
Abhinav Jain ◽  
Richa Garg ◽  
Shreya Dhingra
Keyword(s):  
Observational Study ◽  
Contrast Media ◽  
Adverse Drug Reactions ◽  
Teaching Hospital ◽  
Adverse Reactions ◽  
North India ◽  
Drug Reactions ◽  
Iodinated Contrast ◽  
Radiographic Contrast ◽  
Radiographic Contrast Media

Background: Radiocontrast media are used extensively nowadays to visualize internal organs. Currently, non-ionic iodinated contrast media are used which are generally considered to be safe but some adverse reactions have been reported. Thus, the present study was carried out to analyze the nature and incidence of adverse drug reactions (ADRs) to radiographic contrast media in a teaching hospital. Methods:An observational study carried out for a period of six months in a teaching hospital. Contrast media induced adverse reactions were analyzed in terms of affected organs, rate, causality assessment, severity and preventability. The treatment and outcomes of adverse events were also recorded. Naranjo Probability Scale was used to evaluate the relationship between the contrast agent used and the suspected ADR. The severity of the suspected ADRs was determined using Hartwig Scale and preventability was assessed using modified Schumock and Thornton criterion. Results:A total of 15 suspected ADRs occurred in 11 patients with an incidence of 1.4%. It included 5 (45.4%) males and 6 (54.5%) females (p < 05). The highest percentage (72.7 %) of ADRs was seen in adult patients, the mean age being 40.8 years. Vomiting (33.3%) was the most common ADR noted followed by severe nausea and rashes. 64.7 % of ADRs were categorized as probable and 35.3 % were possible. Adverse reactions required treatment in 46.6% patients. There was no fatality reported. Conclusion:The reactions observed were mild to moderate in severity and occurred within 30 minutes of the administration of the contrast.

scholarly journals The Wonderful DMARD with Multiple Toxicities

2021 ◽  
Vol 5 (7) ◽  
pp. RV5-RV10
Author(s):  
Yashika Kaushal ◽  
Ratibha Kausal ◽  
Isha Sharma
Keyword(s):  
Immune System ◽  
Adverse Drug Reactions ◽  
Adverse Reactions ◽  
Close Monitoring ◽  
Drug Reactions ◽  
Therapy Discontinuation ◽  
Chemotherapy Agent ◽  
Reduce Activity ◽  
Potential Risk Factors ◽  
Rheumatic Drug

Methotrexate is a type of disease-modifying anti-rheumatic drug (DMARD). It is used to reduce activity of the immune system for people who have certain conditions. Methotrexate is a chemotherapy agent and immune system suppressant. Its use may be limited by concerns regarding its adverse reactions. The occurrence of adverse drug reactions in some cases leads to the therapy discontinuation. Although adverse drug reactions (ADR) of methotrexate generally do not pose a serious threat to the health of patients and a reduction in the dose of methotrexate leads to their elimination, in some cases severe toxicities of the drug occur unpredictably. These facts explain the need for close monitoring of the patient’s condition and the identification of potential risk factors for drug toxicity on the part of different organs and functional systems. The purpose of this review is to detail about safety and tolerability of methotrexate.

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

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.

Cutaneous reactions to drugs

2020 ◽  
pp. 5752-5760
Author(s):  
Sarah Walsh ◽  
Daniel Creamer ◽  
Haur Yueh Lee
Keyword(s):  
Adverse Drug Reactions ◽  
Adverse Reactions ◽  
Normal Function ◽  
Stevens Johnson Syndrome ◽  
Drug Reactions ◽  
Drug Induced ◽  
Drug Eruptions ◽  
Fixed Drug ◽  
Iatrogenic Illness ◽  
Systemic Symptoms

Adverse reactions to medications are common and important cause of iatrogenic illness. Severe cutaneous adverse drug reactions include toxic epidermal necrolysis, Stevens–Johnson syndrome, drug reaction with eosinophilia and systemic symptoms, and acute generalized exanthematous pustulosis, which together constitute 2% of all adverse drug reactions and may be life-threatening. Less severe drug-induced skin reactions such as exanthems, urticaria, lichenoid drug rashes, and fixed drug eruptions are more common, sometimes termed benign cutaneous adverse reactions, and generally resolve without sequelae. Drugs may also cause adverse events due to alteration of the normal function of the skin or its appendages. This may take the form of photosensitivity, abnormal pigmentation, or disrupted growth of hair or nails.

Incidence of Roentgen Contrast Medium Reactions after Intravenous Injection in Pre-Registration Trials and Post-Marketing Surveillances

1993 ◽  
Vol 34 (3) ◽  
pp. 210-213 ◽  
Author(s):  
E. Andrew ◽  
T. Haider
Keyword(s):  
Relative Risk ◽  
Adverse Drug Reactions ◽  
Odds Ratio ◽  
Adverse Reactions ◽  
Drug Reactions ◽  
Feasible Method ◽  
Ionic Contrast ◽  
Different Types ◽  
Post Marketing ◽  
The Absolute

The relative risk of adverse drug reactions of ionic versus non-ionic contrast media injected i.v. were compared for different types of trials using odds-ratio. The absolute and relative risk found in large post-marketing trials were compared with that found in the iohexol pre-registration trials. The absolute risks were 2 to 10 times higher in the pre-registration trials compared to the post-marketing surveillances. The relative risk for all adverse drug reactions was 3 to 6 times higher for ionic vs. non-ionic media and independent of pre- or post-registration studies. The odds-ratio seems to be a feasible method of comparing the relative risk of adverse reactions in various trials.

Using the adverse reactions register to study the effects of age and sex on adverse drug reactions

1987 ◽  
Vol 6 (7) ◽  
pp. 863-867 ◽  
Author(s):  
Judy M. Simpson ◽  
D. N. Bateman ◽  
M. D. Rawlins
Keyword(s):  
Adverse Drug Reactions ◽  
Adverse Reactions ◽  
Drug Reactions ◽  
Age And Sex

The Incidence and Nature of Adverse Reactions during Intravenous Acetylcysteine Therapy for Acetaminophen Overdose

2000 ◽  
Vol 16 (2) ◽  
pp. 47-49 ◽  
Author(s):  
Matitiahu Lifshitz ◽  
Perez Kornmehl ◽  
Haim Reuveni
Keyword(s):  
Adverse Drug Reactions ◽  
Adverse Reactions ◽  
Medical Center ◽  
Clinical Manifestations ◽  
Cost Benefit ◽  
Maculopapular Rash ◽  
Oral Formulation ◽  
Drug Reactions ◽  
Acetaminophen Overdose ◽  
History Of

Objective: To determine the incidence of adverse drug reactions in patients with acetaminophen overdose following administration of intravenous acetylcysteine, and to evaluate the cost-benefit ratio of intravenous compared with oral acetylcysteine therapy. Methods: The incidence of adverse drug reactions to intravenous acetylcysteine therapy was studied retrospectively in all patients with acetaminophen overdose who were admitted to Soroka University Medical Center, Beer-Sheva, Israel, from 1994 to 1998. Data were obtained from hospital records. All patients were treated with a 20-hour intravenous regimen according to the Prescott protocol. Special attention was paid to the clinical manifestations of adverse reactions, time of onset, and history of patient allergy and asthma. Cost of therapy (drug prices, hospital per diems) for intravenous versus oral acetylcysteine administration was evaluated in accordance with average rates prevailing in Israel in December 1998. Results: Ninety-two patients, 32 adolescents aged 12–18 years (mean ± SD 14.2 ± 1.9) and 60 adults aged 18–52 years (28.2 ± 3.2), were treated with intravenous acetylcysteine for acetaminophen overdose during the study period. Three patients (3.2%) developed adverse reactions: one adult presented with a maculopapular rash and pruritus, and two adolescents developed mild urticaria; no other adverse reactions were reported. All adverse reactions occurred during administration of the loading dose, 15–20 minutes after initiation of therapy. The reactions subsided a few hours after the acetylcysteine infusion was stopped and did not require antiallergy therapy. None of the three patients had a history of allergy. The 20-hour intravenous acetylcysteine protocol is approximately three times less expensive than the recommended oral regimen in terms of drug cost and length of hospitalization. Conclusions: Intravenous acetylcysteine is a relatively safe antidote for acetaminophen poisoning. The incidence rate of adverse reactions is low, and they are mild and easily controlled by termination of the infusion. We recommend intravenous acetylcysteine therapy, particularly for patients with vomiting caused by the acetaminophen overdose or by oral acetylcysteine therapy. The 20-hour intravenous acetylcysteine therapy has a cost-benefit advantage over oral therapy; however, the oral formulation is not approved by the FDA.

Antidepressant-Induced Adverse Reactions in a Patient with Hemorrhagic Stroke

2005 ◽  
Vol 39 (10) ◽  
pp. 1755-1757 ◽  
Author(s):  
Zoran Bogdanovic ◽  
Jhansi R Nalamati ◽  
John K Kilcullen ◽  
Sunil Dhuper
Keyword(s):  
Adverse Drug Reactions ◽  
Adverse Reactions ◽  
Hemorrhagic Stroke ◽  
Hormone Secretion ◽  
Drug Reactions ◽  
Inappropriate Antidiuretic Hormone Secretion ◽  
Number Of Patients ◽  
Close Supervision ◽  
Post Stroke Depression ◽  
History Of

Objective: To report a case of antidepressant-induced adverse drug reactions in a patient with hemorrhagic stroke. Case Summary: A 56-year-old man developed life-threatening adverse reactions after fluoxetine was added to his previously prescribed regimen of buspirone and olanzapine. One week after starting fluoxetine 60 mg/day, the patient developed syndrome of inappropriate antidiuretic hormone secretion and serotonin syndrome concurrently. The patient had experienced a hemorrhagic stroke before the adverse drug reactions occurred. DISCUSSION: A patient with a history of hemorrhagic stroke developed serious adverse drug reactions when fluoxetine was added to his drug therapy. When the combination therapy was stopped, all adverse effects gradually disappeared and laboratory abnormalities were corrected. The likelihood that the adverse reactions were caused by fluoxetine is probable according to the Naranjo probability scale. In addition, a history of stroke may be a risk factor for the development of such reactions. CONCLUSIONS: Today, patients with depression after experiencing a stroke are treated more effectively, but antidepressant-induced adverse drug reactions may be serious. A growing number of patients are treated for post-stroke depression; they require close supervision and careful dosing of antidepressants to prevent full-blown adverse reactions from occurring.

scholarly journals Adverse drug reactions due to cancer chemotherapy in a tertiary care hospital in south Karnataka: a prospective observational study

2019 ◽  
Vol 8 (12) ◽  
pp. 2635
Author(s):  
Sowmya M. S. ◽  
Basavanna P. L. ◽  
L. Raghavendra Gupta
Keyword(s):  
Observational Study ◽  
Adverse Drug Reactions ◽  
Cancer Chemotherapy ◽  
Prospective Observational Study ◽  
Adverse Reactions ◽  
Tertiary Care ◽  
Care Hospital ◽  
Chemotherapeutic Drugs ◽  
Drug Reactions ◽  
Active Monitoring

Background: Cancer is a multi-cellular disease which can arise from any cell type and organs. Adverse drug reactions (ADR) are undesirable consequence of cancer chemotherapeutic drugs. A great importance has to be given for their assessment, detection, monitoring, reporting and preventing these ADR for the beneficial effects of the patients. So the present study was undertaken for the purpose of detecting and quantifying those adverse reactions which is of some importance in therapeutic setting.Methods: A prospective observational study conducted in chemotherapy ward, male and female patients of any age receiving cancer chemotherapy and presenting with ADR’s in duration of 3 months.Results: 160 patients were observed. Out of 160 patients 123 presented with ADR’s. Most common ADR’s were loss of appetite (67.6), diarrhea (61.8%), vomiting (21.5%), nausea (17.7%), anemia (24.7%). Cisplatin, paclitaxel, oxaliplatin, doxorubicin, gefitinib are common drugs causing ADR’s.Conclusions: Cancer chemotherapeutic drugs are associated with various adverse reactions. This study shows the importance of active monitoring of these reactions and measures to prevent their effects early in the treatment of cancer.

scholarly journals Dermoscopic Aspects of Cutaneous Adverse Drug Reactions

2021 ◽  
pp. e2021136
Author(s):  
Gabriela Rossi ◽  
André Da Silva Cartell ◽  
Renato Marchiori Bakos
Keyword(s):  
Adverse Drug Reactions ◽  
Adverse Reactions ◽  
Stevens Johnson Syndrome ◽  
Drug Reactions ◽  
Acute Generalized Exanthematous Pustulosis ◽  
Johnson Syndrome ◽  
Vascular Structures ◽  
Systemic Symptoms ◽  
Exanthematous Pustulosis ◽  
Cutaneous Adverse Reactions

Background: Little is known about the dermoscopic evaluation of cutaneous adverse drug reactions (CADRs). Objectives: To evaluate the dermoscopic patterns of CADRs and identify those associated with severe cutaneous adverse reactions to drugs (SCARDs). Patients and Methods: Patients included in this study from May 2015 to April 2016 had presented with CADRs. CADR presentation and classification were based on standard criteria. SCARDs included Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), overlap SJS/TEN, drug reaction with eosinophilia and systemic symptoms (DRESS), and acute generalized exanthematous pustulosis (AGEP). The dermoscopic features of CADRs were described and compared according to the severity of the reactions. Results: Sixty-nine patients were included. Sixteen patients (23.2%) presented SCARDs. The main dermoscopic findings in SJS, overlap SJS/TEN and TEN were black dots or necrotic areas (100%). Erosion [respectively, 4/6 (66.7%), 3/3 (100%) and 1/1 (100%)], necrotic borders [respectively, 4/6 (66.7%), 3/3 (100%) and 1/1, (100%)] and epidermal detachment [respectively, 5/6 (83.3%); 2/3 (66.7%) and 1/1 (100%)] were also common among these reactions. Erythema and purpuric dots were the main dermoscopic findings [respectively, 5/6 (83.3%) and 4/6 (66.7%)] in DRESS. In non-severe reactions, the most prevalent structures were erythema and purpura in exanthema [respectively, 31/33 (93.9%) and 24/33 (72.7%)] and erythema and vascular structures in urticarial reactions [respectively, 6/6 (100%) and 3/6 (50%)]. Black dots or necrotic areas, epidermal detachment, necrotic borders and erosion were highly associated with SCARDs (P < 0.001). Conclusions: Dermoscopy improves clinical recognition of SCARDs.

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