The safety of carbamylated monomeric allergoids for sublingual immunotherapy. Data from a pharmacovigilance study

Immunotherapy ◽  
2020 ◽  
Vol 12 (3) ◽  
pp. 195-202 ◽  
Author(s):  
Enrico Compalati ◽  
Cristoforo Incorvaia ◽  
Sara Urbano ◽  
Paola Strada ◽  
Franco Frati
Keyword(s):  
Adverse Drug Reactions ◽  
Sublingual Immunotherapy ◽  
Systemic Reaction ◽  
Subcutaneous Immunotherapy ◽  
Drug Reactions ◽  
Safety Database ◽  
Systemic Reactions ◽  
Spontaneous Reports ◽  
Post Marketing

Aim: Sublingual immunotherapy (SLIT) is significantly less concerned by systemic reactions than subcutaneous immunotherapy. Allergoids were introduced to reduce systemic reaction to subcutaneous immunotherapy, but may also be used for SLIT. Methods: This pharmacovigilance study evaluated the post-marketing reports collected in a safety database, including the number and the type (serious or not serious) of adverse drug reactions (ADRs) in Italy by SLIT with the carbamylated monomeric allergoid (CMA). Results: More than 15,000,000 CMA tablets were administered, with 25 spontaneous reports of ADRs, only two being serious. Conclusion: The rate of ADRs to CMA we found in this pharmacovigilance survey, corresponding to 0.0004% of all administered doses, is far lower than the rates commonly reported for allergen SLIT products.

scholarly journals A Multi-Agent System for Reporting Suspected Adverse Drug Reactions

2014 ◽  
Vol 6 (3) ◽  
Author(s):  
Yanqing Ji ◽  
Fangyang Shen ◽  
See-Yan Lau ◽  
John Tran
Keyword(s):  
Adverse Drug Reactions ◽  
Healthcare Professionals ◽  
Public Health Problem ◽  
Reporting Rate ◽  
Drug Reactions ◽  
Data Mining Approach ◽  
Spontaneous Reports ◽  
Post Marketing ◽  
Multi Agent ◽  
Suspected Adverse Drug Reactions

Adverse drug reactions (ADRs) represent a serious worldwide public health problem. Current post-marketing ADR detection approaches largely rely on spontaneous reports filed by various healthcare professionals such as physicians, pharmacists et.al.. Underreporting is a serious deficiency of these methods - the actually reported adverse events represent less than 10% of all cases. Studies show that two important reasons that cause the underreporting are: 1) healthcare professionals are unaware of encountered ADRs, especially for those unusual ADRs; 2) they are too busy to voluntarily report ADRs since it takes a lot of time to fill out the reporting forms. This paper addresses these two issues by developing a multi-agent ADR reporting system. The system 1) helps healthcare professionals detect the potential causal relationship between a drug and an ADR by analyzing patients’ electronic records via both case-based analysis and statistical data mining approach; 2) allows healthcare professionals to add new rules to signal potential ADRs based on their medical expertise; 3) makes the reporting much easier by automatically linking the patients’ electronic data with the reporting form. A functioning prototype of the system has been developed. The proposed data analysis approaches as well as the performance of the system have been tested. The results indicate that this system has a great potential to improve the spontaneous reporting rate of suspected adverse drug reactions.

scholarly journals Dose dependence of efficacy but not of safety in sublingual immunotherapy

2016 ◽  
Vol 65 (1) ◽  
Author(s):  
F. Frati ◽  
C. Incorvaia ◽  
F. Marcucci ◽  
L. Sensi ◽  
G. Di Cara ◽  
...  
Keyword(s):  
Sublingual Immunotherapy ◽  
Clinical Symptoms ◽  
Meta Analysis ◽  
Dose Dependence ◽  
Subcutaneous Immunotherapy ◽  
High Dose ◽  
Systemic Reactions ◽  
Significant Difference

Sublingual immunotherapy (SLIT) currently represents, as indicated by meta-analysis of its efficacy and safety, a valid option to the generally used traditional subcutaneous immunotherapy (SCIT) for treating respiratory allergy. Regarding efficacy, recent studies demonstrated that, similar to what has already been observed in SCIT as well as in experimental and clinical studies about the magnitudo of allergen exposure, the effectiveness on both clinical symptoms and immunologic changes depends on the amount of allergen administered during treatment. In addition, in vitro studies addressed with the role of dendritic cells, currently considered to be of pivotal importance in orienting toward tolerance the immune response to allergens, showed that the internalisation of allergen molecules, which is followed by tolerogenic presentation to T cells, depends on the amount of allergen. However, such dose dependence is not apparent concerning the safety. In fact, the comparison of studies respectively conducted with high and low allergen doses did not show differences in the rate of systemic reactions, which in any case never had the presentation of anaphylaxis, and instead a significant difference in the rate of local reactions, following the oral and gastrointestinal contact with the allergen extract, in favour of high dose studies.

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 A single-centre retrospective study of systemic reactions to subcutaneous immunotherapy

2020 ◽  
Author(s):  
Kara Robertson ◽  
Nazanin Montazeri ◽  
Urvashi Shelke ◽  
Samira Jeimy ◽  
Harold Kim
Keyword(s):  
Incidence Rate ◽  
Best Practice ◽  
Systemic Reaction ◽  
Retrospective Chart Review ◽  
Patient Characteristics ◽  
Subcutaneous Immunotherapy ◽  
Single Centre ◽  
Epinephrine Administration ◽  
Epinephrine Injection ◽  
Systemic Reactions

Abstract BackgroundSubcutaneous immunotherapy (SCIT) is the standard approach for treating patients with sensitizations to aeroallergens. However, immunotherapy can trigger severe systemic reactions if delivered inappropriately or to high risk patients. We sought to characterize and quantify SCIT systemic reactions requiring epinephrine administration during a 6-year period in a Canadian setting following the recommendations for components and dosages published in the 2010 Canadian Society of Allergy and Clinical Immunology (CSACI) Immunotherapy Manual. MethodsA single centre retrospective chart review was performed for all patients with systemic reactions to subcutaneous immunotherapy requiring intramuscular epinephrine injection between January 2011 and October 2017. Each systemic reaction requiring epinephrine was reviewed for baseline patient characteristics, details of the reaction, and reaction severity. Research ethics approval was obtained through McMaster University.Results28 of 380 patients experienced a systemic reaction requiring epinephrine administration, with an incidence rate of 1 per 1,047 injection visits (0.095%). 26 of the 28 reactions occurred within the mandatory 30-minute observation period post allergen immunotherapy. Of the 28 patients that experienced a systemic reaction to SCIT, 11 patients had asthma and 5 patients had a history of possible food allergy. All of the systemic reactions occurred during injections from vial number 4, and five patients reacted to their first shot of a re-ordered extract. 10 of the 28 patients required more than one intramuscular injection of epinephrine, and 20 of 28 patients were transferred to the hospital by ambulance.ConclusionsThis is the first Canadian study to review patients with systemic reactions to subcutaneous immunotherapy. Several best practice methods were employed throughout the study to optimize subcutaneous delivery of immunotherapy extract, and our recorded per injection incidence rate for systemic reactions was comparable or below the rate published in similar studies. The recommendations in the CSACI Immunotherapy Manual provide an approach to standardizing prescriptions for SCIT to maximize immunotherapy efficacy and reduce the risk of systemic reactions, though similar studies in larger multicenter settings are needed to confirm these observations. These observations provide important objective information to clinicians about the potential risks for systemic reactions in patients considering SCIT.

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.

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.

Spontaneous reports of hypersensitivity adverse drug reactions in Portugal: a retrospective analysis

2020 ◽  
Vol 19 (6) ◽  
pp. 763-769
Author(s):  
Diogo Mendes ◽  
Ana Rita Oliveira ◽  
Carlos Alves ◽  
Francisco Batel Marques
Keyword(s):  
Retrospective Analysis ◽  
Adverse Drug Reactions ◽  
Drug Reactions ◽  
Spontaneous Reports

scholarly journals A single centre retrospective study of systemic reactions to subcutaneous immunotherapy

2020 ◽  
Vol 16 (1) ◽  
Author(s):  
Kara Robertson ◽  
Nazanin Montazeri ◽  
Urvashi Shelke ◽  
Samira Jeimy ◽  
Harold Kim
Keyword(s):  
Incidence Rate ◽  
Best Practice ◽  
Systemic Reaction ◽  
Retrospective Chart Review ◽  
Patient Characteristics ◽  
Subcutaneous Immunotherapy ◽  
Single Centre ◽  
Epinephrine Administration ◽  
Epinephrine Injection ◽  
Systemic Reactions

Abstract Background Subcutaneous immunotherapy (SCIT) is the standard approach for treating patients with sensitizations to aeroallergens. However, immunotherapy can trigger severe systemic reactions if delivered inappropriately or to high risk patients. We sought to characterize and quantify SCIT systemic reactions requiring epinephrine administration during a 6-year period in a Canadian setting following the recommendations for components and dosages published in the 2010 Canadian Society of Allergy and Clinical Immunology (CSACI) Immunotherapy Manual. Methods A single centre retrospective chart review was performed for all patients with systemic reactions to subcutaneous immunotherapy requiring intramuscular epinephrine injection between January 2011 and October 2017. Each systemic reaction requiring epinephrine was reviewed for baseline patient characteristics, details of the reaction, and reaction severity. Research ethics approval was obtained through McMaster University. Results 28 of 380 patients experienced a systemic reaction requiring epinephrine administration, with an incidence rate of 1 per 1,047 injection visits (0.095%). 26 of the 28 reactions occurred within the mandatory 30-minute observation period post allergen immunotherapy. Of the 28 patients that experienced a systemic reaction to SCIT, 11 patients had asthma and 5 patients had a history of possible food allergy. All of the systemic reactions occurred during injections from vial number 4, and five patients reacted to their first shot of a re-ordered extract. 10 of the 28 patients required more than one intramuscular injection of epinephrine, and 20 of 28 patients were transferred to the hospital by ambulance. Conclusions This is the first Canadian study to review patients with systemic reactions to subcutaneous immunotherapy. Several best practice methods were employed throughout the study to optimize subcutaneous delivery of immunotherapy extract, and our recorded per injection incidence rate for systemic reactions was comparable or below the rate published in similar studies. The recommendations in the CSACI Immunotherapy Manual provide an approach to standardizing prescriptions for SCIT to maximize immunotherapy efficacy and reduce the risk of systemic reactions, though similar studies in larger multicenter settings are needed to confirm these observations. These observations provide important objective information to clinicians about the potential risks for systemic reactions in patients considering SCIT.

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