scholarly journals Incidence of adverse drug reactions in patients taking anti-tuberculosis treatment

2019 ◽  
Vol 6 (6) ◽  
pp. 1732
Author(s):  
Tushar R. Gosai ◽  
Jayesh D. Balat ◽  
Hiren R. Trivedi
Keyword(s):  
Risk Factor ◽  
Prospective Study ◽  
Treatment Period ◽  
Adverse Reactions ◽  
Clinical History ◽  
Close Monitoring ◽  
Drug Reactions ◽  
Skin Reactions ◽  
High Incidence ◽  
Loss Of Balance

Background: High incidence of infection has caused a large number of morbidity and mortality which is partly due to serious adverse reactions induced by Anti-Tuberculosis (Anti-TB) drugs. In present prospective study an attempt is made to estimate the incidence and risk factor for ADRs among patients treated for tuberculosis.Methods: All the new patients starting their treatment with selected six DOT center were enrolled in study. All patient's complete clinical history was recorded. They were followed regularly for occurrence of ADR till end of their treatment.Results: Total of 108 patients (67 male and 41 female) had taken and completed their treatment during the study period (March 2007 - April 2008) and were observed for occurrence of ADR during their treatment period. Out of total108, 28 patients (25.9%) experienced one of the ADR, out of 28 patients, 12 (42.85%) patients developed GIT intolerance, and hepatitis was seen in 8 (28.57%) patients, while 4 (14.48%) patients developed skin reactions. Only 3 (7.14%) patient developed dizziness and loss of balance, which was relieved by reduction of dose of streptomycin.Conclusions: With close monitoring and on time action, RNTCP DOTs regimens can be safely and successfully administrated.

scholarly journals Analysis of Antineoplastics, Immunomodulators, Antibiotics and Analgesics Adverse Drug Reactions Reports Submitted to the Pharmacovigilance Database in Jordan

2017 ◽  
Vol 14 (2) ◽  
pp. 541-546
Author(s):  
Mohammed Alsbou ◽  
Adel Batarseh ◽  
Nidda Bawaresh ◽  
Jaber Jaber ◽  
Gadeer Qawasmi ◽  
...  
Keyword(s):  
Adverse Drug Reactions ◽  
Adverse Reactions ◽  
Blood System ◽  
Close Monitoring ◽  
Body System ◽  
Drug Reactions ◽  
Skin Reactions ◽  
Rational Drug ◽  
Acral Erythema ◽  
Pharmacovigilance Database

ABSTRACT: A national pharmacovigilance database was created recently at the Rational Drug Use and Pharmacovigilance Department at Jordan Food and Drug Administration (JFDA). This study was based on the analysis of the adverse drug reactions (ADRs) reports submitted to the national pharmacovigilance (PV) database in Jordan from 2010 to 2014.The aims of this study were to identify the most frequently body system classes and the most common ADRs for the four major classes of dugs implicated in the PV database and include: antineoplastics, immunomodulators, antibiotics and analgesics. The most affected systems by ADRs in our study were the skin and the gastrointestinal (GI) systems. The skin ADRs associated with the use of antineoplastics were skin rash, hand and foot syndrome and acral erythema, and the most frequent GI ADRs were vomiting and diarrhea. The most affected system by the use of the immunomodulators was the blood system and the most common ADRs were anemia, thrombocytopenia and neutropenia. The most commonly ADRs following analgesics use were GI bleeding and duodenal ulcer and the skin reactions were rash, itching and flushing. Analysis of the national PV database provides close monitoring and more information about the safety of medicine in Jordan. All Health care provider should be aware of the importance of reporting of adverse reactions and should be encouraged to report suspected ADRs and be trained in detecting, diagnosing and treating patients with adverse effects of drugs.

scholarly journals INVESTIGATION OF MEDICALLY INDUCED SKIN REACTIONS BASED ON THE ANALYSIS OF REPORTS OF ADVERSE DRUG REACTIONS IN THE REPUBLIC OF CRIMEA (FROM 2009 TO 2016)

2019 ◽  
Vol 7 (1) ◽  
pp. 32-41 ◽  
Author(s):  
A. V. Matveev ◽  
А. E. Krasheninnikov ◽  
E. A. Egorova ◽  
Е. I. Konyaeva
Keyword(s):  
Adverse Reactions ◽  
Drug Hypersensitivity ◽  
Clinical Manifestations ◽  
World Health ◽  
Report Cards ◽  
Hypersensitivity Reactions ◽  
Drug Reactions ◽  
Skin Reactions ◽  
Drug Hypersensitivity Reactions ◽  
The Republic

Drug hypersensitivity reactions are among the most important problems that arise when using drugs. The occurrence of such reactions in the population is at least 7% and tends to a constant increase. The most frequent manifestations of drug hypersensitivity reactions are medically induced skin lesions.The aimof this research was to study and analyze the cases of development of skin drug reactions on the basis of the reports on the adverse reactions (ADRs) of the drugs, registered in the Republic of Crimea in the period from 2009 to 2016.Materials and methods.The objects of the research were report cards about the adverse reactions, registered in the regional base (registry) of spontaneous messages called ARCADe (Adverse Reactions in Crimea, Autonomic Database) for the period from 2009 to 2016. During the analysis of the report cards, 2,698 cases of the development of skin drug reactions arising in response to the use of drugs in patients were selected. The study of the frequency of occurrence of skin drug reactions in the application of various groups of drugs was carried out taking into account the codes of the Anatomical Therapeutic Chemical (ATC) Сlassification System of drugs of the World Health Organization (WHO).Results.Of the study showed that the development of skin drug reactions was most often associated with the use of antimicrobial agents for internal use, nonsteroidal anti-inflammatory drugs (NSAIDs), drugs for the treatment of diseases of the gastrointestinal tract and agents that affect the nervous system. Among the clinical manifestations of skin drug reactions, generalized and localized rashes prevailed, and itching and hyperemia of the skin were much less common in patients. The analysis of age categories showed that the most frequently medically induced reactions occurred in children from birth to 3 years, as well as in the age group of patients from 46 to 60 years. The risk factors identified in the course of the analysis, were female gender, early childhood and old age, as well as the presence of aggravated drug allergy history.Conclusion.Drug hypersensitivity reactions create certain difficulties in clinical practice related to the diagnosis, treatment and prophylaxis, and may also cause danger to health or life of patients. In this connection, the study of such adverse reactions is the most important task of practical health care and requires direct participation of doctors of all specialties.

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.

Undesirable effects of polypharmacotherapy in patients with cancer-associated pain treated under palliative care

Ból ◽  
2017 ◽  
Vol 18 (4) ◽  
pp. 11-19
Author(s):  
Jarosław Woroń ◽  
Wojciech Leppert ◽  
Radosław Tymiński ◽  
Michał Graczyk ◽  
Halina Kutaj–Wąsikowska ◽  
...  
Keyword(s):  
Palliative Care ◽  
Drug Interactions ◽  
Adverse Drug Reactions ◽  
Adverse Reactions ◽  
Legal Aspects ◽  
Drug Reactions ◽  
Patients With Cancer ◽  
High Incidence

In patients with pain associated with cancer that is treated as part of palliative care, the most commonly used method is polypharmacotherapy. From the analysis of adverse reactions in this group of patients, it appears that the high incidence of adverse drug reactions occurring in this group of patients is due to the undesired drug interactions. Based on pharmacoepidemiological analysis of pharmacotherapy of 600 patients, 373 cases of adverse drug reactions were identified, with the consequence of adverse drug reactions. The paper presents an analysis of these interactions, identifying their sources and methods of prevention, and discussing their legal aspects.

scholarly journals Cutaneous Adverse Drug Reactions / Dematološka neželjena dejstva lekova

2012 ◽  
Vol 4 (2) ◽  
pp. 61-76
Author(s):  
Lidija Kandolf-Sekulović ◽  
Tatjana Radević
Keyword(s):  
Adverse Effects ◽  
Adverse Drug Reactions ◽  
Adverse Reactions ◽  
Skin Diseases ◽  
Clinical Manifestations ◽  
Drug Intake ◽  
Drug Reactions ◽  
Drug Induced ◽  
Skin Reactions ◽  
Wide Range

Abstract Adverse drug reactions may be defined as undesirable clinical manifestations resulting from administration of a particular drug; this includes reactions due to overdose, predictable side effects, and unanticipated adverse manifestations. Adverse drug effects on the skin are among the most frequent reactions and, according to a study, account for approximately 14% of all adverse drug reactions. However, the incidence of cutaneous adverse effects in general population is unknown. Systemic drug administration results in various cutaneous adverse reactions, and medications used in the treatment of skin diseases themselves have their own adverse effects. Adverse drug reactions include a wide range of effects, from harmless exanthema of short duration, urticaria to systemic cutaneous reactions such as drug rash with eosinophilia and systemic symptoms (DRESS) or toxic epidermal necrolysis. Exanthematous eruptions and urticaria are the two most common forms of cutaneous drug reactions. Less common include fixed eruptions, lichenoid, pustular, bullous and vasculitis reactions. The most severe cutaneous and mucosal adverse drug reactions are epidermal necrolysis, which is usually drug-induced, DRESS syndrome, and acute generalized exanthematous pustulosis. Therefore, the diagnostic of adverse drug reactions requires a detailed history of drug intake and development of skin disorders, excellent knowledge of clinical presentations for a wide range of drug-induced skin reactions as well as of the very medications being taken by patients. In addition to details on drug intake, it is necessary to learn about taking herbal and alternative preparations, which may also cause adverse reactions. A drug started within 6 weeks of the development of disorders is considered the most common cause of adverse reaction, as well as drugs taken periodically but regularly. Once a reaction has occurred, it is important to prevent future similar reactions with the same drug or a cross-reacting medication. Early withdrawal of all potentially responsible drugs is essential, particularly in case of severe 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 Safety of COVID-19 Vaccinations—We Should Rethink the Policy

Vaccines ◽  
2021 ◽  
Vol 9 (7) ◽  
pp. 693
Author(s):  
Harald Walach ◽  
Rainer J. Klement ◽  
Wouter Aukema
Keyword(s):  
Side Effects ◽  
Confidence Interval ◽  
Field Study ◽  
Adverse Reactions ◽  
Safety Data ◽  
European Medicines Agency ◽  
Point Estimate ◽  
Drug Reactions ◽  
Vaccination Policy ◽  
Risks And Benefits

Background: COVID-19 vaccines have had expedited reviews without sufficient safety data. We wanted to compare risks and benefits. Method: We calculated the number needed to vaccinate (NNTV) from a large Israeli field study to prevent one death. We accessed the Adverse Drug Reactions (ADR) database of the European Medicines Agency and of the Dutch National Register (lareb.nl) to extract the number of cases reporting severe side effects and the number of cases with fatal side effects. Result: The NNTV is between 200–700 to prevent one case of COVID-19 for the mRNA vaccine marketed by Pfizer, while the NNTV to prevent one death is between 9000 and 50,000 (95% confidence interval), with 16,000 as a point estimate. The number of cases experiencing adverse reactions has been reported to be 700 per 100,000 vaccinations. Currently, we see 16 serious side effects per 100,000 vaccinations, and the number of fatal side effects is at 4.11/100,000 vaccinations. For three deaths prevented by vaccination we have to accept two inflicted by vaccination. Conclusions: This lack of clear benefit should cause governments to rethink their vaccination policy.

scholarly journals Prospective study of 5-day challenge with penicillins in children

2020 ◽  
Vol 4 (1) ◽  
pp. e000734
Author(s):  
Birgitte Tusgaard Petersen ◽  
Josefine Gradman
Keyword(s):  
Prospective Study ◽  
Children And Adolescents ◽  
Provocation Test ◽  
Specific Ige ◽  
Hypersensitivity Reactions ◽  
Skin Reactions ◽  
Full Dose ◽  
Culprit Drug ◽  
Drug Provocation Test ◽  
Registration Number

ObjectivesTo examine if a 5-day challenge with penicillin improves the diagnostic sensitivity compared with a single full dose in children with mild skin reactions.DesignSubjects referred with suspected allergy to penicillin were consecutively included. Irrespectively of the morphology of the index reaction and the result of specific IgE, all subjects underwent a two-step titrated drug provocation test (DPT) with the culprit drug followed by a 5-day challenge at home.ParticipantsChildren and adolescents aged 0–18 years referred to allergic workup for penicillin hypersensitivity at two paediatric Danish centres. Only subjects with non-severe skin reactions were included.ResultsA total of 305 subjects were included and 22 (7%) of the DPTs were positive. Three subjects reacted within 1 hour of the first full dose and nine reacted 1–8 hours after the first full dose. Additional 10 positive reactions were observed during the prolonged provocation. Seven subjects reacted after the second full dose and three reacted after 3–6 days. Only mild skin rashes were observed. Eighteen subjects had a specific IgE to a penicillin >0.1 kU/L. Only one of these had a positive DPT.ConclusionIn children, a DPT with penicillins should include at least two full doses. In children with mild hypersensitivity reactions it may be safe to perform DPTs despite a low specific IgE.Trial registration numberNCT04331522

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