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.

scholarly journals Global Perspective of Paediatric Pharmacovigilance and its Importance: Where Have We Reached?

2021 ◽  
pp. 276-288
Author(s):  
S. Narmada ◽  
M. P. Gowrav ◽  
Akhilesh Akki ◽  
Vishakharaju Motupalli ◽  
V. Balamuralidhara ◽  
...  
Keyword(s):  
Adverse Drug Reactions ◽  
Adverse Reactions ◽  
Healthcare Providers ◽  
The United States ◽  
Reporting Rate ◽  
Global Perspective ◽  
Drug Reactions ◽  
Paediatric Patients ◽  
Post Marketing Surveillance ◽  
Post Marketing

Pharmacovigilance is a tool proposed during the post-marketing process of the pharmaceutical product lifecycle to monitor drug safety in everyday life and to identify adverse drug reactions. The identification of adverse reactions, however, is a significant cause of concern and a challenge to pharmacovigilance structures. Regulators use three basic principles in determining the risk-benefit balance to decide whether to approve a drug or a biological product and to maintain it on the market: safety, quality and effectiveness. In particular, paediatric patients, especially new-borns and infants, are at risk of drug-related adverse reactions. Drugs are also prescribed in an unlicensed and/or off-label manner to new-borns, infants and teenagers, leading paediatric patients to a higher risk of experiencing adverse drug reactions (ADRs). ADRs in children < 2 years of age are often reported and can often be alarming. The practise of paediatric pharmacovigilance needs to be strengthened by stimulating spontaneous paediatric reporting and successful post-marketing surveillance. The current study highlights the importance of paediatric pharmacovigilance and the role of different stakeholders like healthcare providers, regulators, and consumers in increasing the ADR reporting rate. Also, it discusses the pharmacovigilance tools and various initiatives that are taken by various regulatory authorities like the United States, the United Kingdom, Japan, and India.

Adverse reactions: getting the best from the yellow card system

1980 ◽  
Vol 18 (19) ◽  
pp. 75-76
Keyword(s):  
Adverse Drug Reactions ◽  
Adverse Reactions ◽  
Drug Reactions ◽  
Yellow Card ◽  
Post Marketing Surveillance ◽  
Post Marketing ◽  
Card System ◽  
The Many ◽  
Source Of Information

Yellow cards provide the Committees on Safety of Medicines (CSM) and Dental and Surgical Materials (CDSM) with their major source of information on the occurrence of adverse drug reactions. Of the many forms of post-marketing surveillance now in use, it is the most widely applied and probably the cheapest. Three-quarters of the 23,000 reports received by the Committees in 1978 and 1979 were through the yellow card system. However, probably only 10% of serious adverse reactions are reported to the Committees.1 Why is reporting reactions important, and how can doctors help to make the system work better?

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 Steroid-Resistant Graves’ Orbitopathy Treated with Tocilizumab in Real-World Clinical Practice: A 9-Year Single-Center Experience

2021 ◽  
Vol 10 (4) ◽  
pp. 706
Author(s):  
José V. Pérez-Moreiras ◽  
María Varela-Agra ◽  
M. Consuelo Prada-Sánchez ◽  
Guillermo Prada-Ramallal
Keyword(s):  
Adverse Drug Reactions ◽  
Disease Recurrence ◽  
Clinical Activity ◽  
Eyelid Retraction ◽  
Single Center ◽  
Drug Reactions ◽  
Steroid Resistant ◽  
Single Center Experience ◽  
Graves Orbitopathy ◽  
The Absolute

This study aimed to assess the effectiveness and safety of tocilizumab use for the treatment of active steroid-resistant Graves’ orbitopathy (GO). A retrospective longitudinal study was conducted by reviewing the medical records at a single center between November 2009 and December 2018. A total of 114 patients with steroid-resistant Graves’ orbitopathy were examined and treated with tocilizumab, of which 54 adults met the inclusion criteria. No concomitant medication for the treatment of orbitopathy was used. The main primary outcomes included changes from baseline in the Clinical Activity Score (CAS) and thyrotropin receptor antibody (TRAb) levels throughout therapy with tocilizumab. The absolute responses to treatment were defined as the achievement of CAS ≤ 1 and TRAb ≤ 10 U/L. A composite ophthalmic score including CAS, proptosis, eyelid retraction, and diplopia was used to evaluate individual improvement in GO. Adverse drug reactions were also assessed. Analysis of the patient’s CAS and TRAb levels showed meaningful reductions during tocilizumab treatment. Differences between values at baseline and subsequent time points were statistically significant (p < 0.001 for all comparisons). The absolute CAS response (CAS = 0 or 1) was achieved in 74% (37/50) of patients after the fourth dose of tocilizumab (at week 16), with a TRAb response being achieved in 55% (23/42) of patients. The relative CAS response (reduction ≥ 2 points) was achieved in 90.9% of patients (40/44) after the first dose of tocilizumab (at week 4). Measurements of proptosis (reduction ≥ 2 mm in 78% of patients, 42/54) and eyelid retraction (reduction ≥ 2 mm in 75%, 33/44), and the prevalence of diplopia (improvement in 68%, 19/28) were significantly reduced after the last dose of tocilizumab (p < 0.001 for all comparisons). GO improved in 98% (53/54) of patients when at least two criteria of the composite evaluation were required. Four patients exhibited disease recurrence, defined as an increase in CAS of ≥2 points in the six months following the date of inactivation. Most adverse drug reactions were mild or moderate in severity. In conclusion, our data suggest that a course of at least 4 months (one monthly dose) of tocilizumab therapy provides a significant benefit to patients with active moderate-to-severe steroid-resistant GO.

Alert systems for post-marketing surveillance of adverse drug reactions

1993 ◽  
Vol 12 (24) ◽  
pp. 2383-2393 ◽  
Author(s):  
Michaela Praus ◽  
Fritz Schindel ◽  
Reinhard Fescharek ◽  
Sabine Schwarz
Keyword(s):  
Adverse Drug Reactions ◽  
Drug Reactions ◽  
Post Marketing Surveillance ◽  
Post Marketing

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.

scholarly journals Drug-Drug-Dietary interactions in pharmacotherapy of GIT medication: A review

2020 ◽  
Vol 11 (SPL4) ◽  
pp. 2903-2909
Author(s):  
Akula sowjanya ◽  
Abhisek Pal
Keyword(s):  
Drug Therapy ◽  
Drug Interactions ◽  
Food Consumption ◽  
Adverse Drug Reactions ◽  
Drug Effect ◽  
Google Scholar ◽  
Drug Reactions ◽  
Common Drug ◽  
Different Types ◽  
Dietary Interactions

Successful drug therapy depends on the interaction between drug-drug and drug-diet. Drug interactions are a vital reason for causing adverse drug reactions and modify one drug effect by another drug and these kinds of interactions can increase or decrease the effectiveness of the drug. Polypharmacy could be a major risk for Drug-Drug and Drug-food interactions. Food Consumption can alter the effect of drugs by interfering either with their pharmacokinetics or pharmacodynamics processes. Anti-ulcer drugs are used to treat different types of ulcer and that may interact with another drug showing undesirable effects. GIT medications interfere with another type of medication either with at the pharmacokinetic and pharmacodynamic level. The main objective of this article is to review data regarding common Drug-drug & Drug-food interactions related to GIT medications. Data was collected from Google Scholar, PubMed, and Scopus databases, and they were reviewed for publication on drug-drug & drug-food interactions related to GIT medications. This data is very helpful for pharmacists while reviewing and analyzing prescribed medication, especially in geriatrics prescriptions.

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