scholarly journals Signal Messages in Pediatric Practice

2018 ◽  
Vol 6 (4) ◽  
pp. 180-186
Author(s):  
G. V. Kutekhova ◽  
E. O. Zhuravleva ◽  
M. A. Darmostukova ◽  
I. I. Snegireva ◽  
N. Yu. Velts ◽  
...  
Keyword(s):  
Weight Gain ◽  
Adverse Reactions ◽  
Control Program ◽  
Individual Case ◽  
Pediatric Practice ◽  
Global Database ◽  
Spontaneous Reports ◽  
Post Marketing ◽  
Pharmacovigilance Risk Assessment Committee ◽  
Assessment Committee

Abstract. Detection and analysis of drug safety signals in children is a mandatory part of pharmacovigilance. The criteria for evaluating signals of adverse effects were considered. Spontaneous reports databases as a source for detecting signaling information about adverse reactions, including in children were used. More than 17.5 million cases of adverse reactions identified in WHO global database of individual case safety reports — VigiBase which was detected since 1968 in 120 countries — members of the WHO Drug Treatment Control Program. Of these, 1.5 million cases of adverse reactions occur in childhood. Objective: search and analysis for signal information in the post-marketing period of the use of drugs in children to increase the safety of pharmacotherapy in pediatric practice. Results: а causal relationship between desloratadine and weight gain was detected. Desloratadine is an active metabolite of loratadine so the researchers have considered reports on desloratadine and also on loratadine. In VigiBase there are reports of weight gain when taking desloratadine (44 messages) and loratadine (115 messages) in 2016. Among them, 22 reports on weight gain in children from 2 to 11 years. The Pharmacovigilance Risk Assessment Committee of the European Medical Agency (PRAC EMA) recommended marketing authorization holders to add an information about weight gain in children in prescribing information of drugs which contains desloratadine and loratadine. In September 2017, the Committee on Drugs for Human Use, following a review and analysis of VigiBase, approved the recommendations of PRAC EMA. Appropriate changes were made to the instructions for medical use for loratadine tablets. Conclusions. These results confirm the importance of long post-marketing studies, the results of which will provide significant assistance in improving the safety of pharmacotherapy in children.

scholarly journals Analysis of Thrombotic Adverse Reactions of COVID-19 AstraZeneca Vaccine reported to EudraVigilance database

2021 ◽  
Author(s):  
Mansour Tobaiqy ◽  
Hajer Elkout ◽  
Katie MacLure
Keyword(s):  
Adverse Reactions ◽  
Blood Clot ◽  
Descriptive Study ◽  
World Health ◽  
European Medicines Agency ◽  
Research Groups ◽  
Spontaneous Reports ◽  
Pharmacovigilance Risk Assessment Committee ◽  
Assessment Committee ◽  
Health Organization

The development of safe, effective, affordable vaccines against COVID-19 remains the cornerstone to mitigating this pandemic. Early December 2020, multiple research groups had designed potential vaccines. From 11 March 2021, several European countries temporarily suspended the use of the Oxford-AstraZeneca vaccine amid reports of blood clot events and death of a vaccinated person, despite the European Medicines Agency and the World Health Organization assurance that there was no indication that vaccination was linked. This study aimed to identify and analyse the thrombotic adverse reactions associated with Oxford-AstraZeneca vaccine. This was a retrospective descriptive study using spontaneous reports submitted to the EudraVigilance database in the period from 17 February to 12 March 2021. There were 54,571 adverse reaction reports of which 28 were associated with thrombotic adverse reactions. Three fatalities were related to Pulmonary Embolism and 1 fatality to Thrombosis. With 17 million people having had the AstraZeneca vaccine, these are extremely rare events. The EMA Pharmacovigilance Risk Assessment Committee (18 March 2021) concluded that the vaccine was safe, effective and the benefits outweighed the risks. Conducting further analyses based on more detailed thrombotic adverse event reports, including patients characteristics and comorbidities, may enable assessment of the causality with higher specificity.

scholarly journals Analysis of Thrombotic Adverse Reactions of COVID-19 AstraZeneca Vaccine Reported to EudraVigilance Database

Vaccines ◽  
2021 ◽  
Vol 9 (4) ◽  
pp. 393
Author(s):  
Mansour Tobaiqy ◽  
Hajer Elkout ◽  
Katie MacLure
Keyword(s):  
Adverse Reactions ◽  
Blood Clot ◽  
Descriptive Study ◽  
World Health ◽  
European Medicines Agency ◽  
Research Groups ◽  
Spontaneous Reports ◽  
The World ◽  
Pharmacovigilance Risk Assessment Committee ◽  
Assessment Committee

The development of safe, effective, affordable vaccines against COVID-19 remains the cornerstone to mitigating this pandemic. Early in December 2020, multiple research groups had designed potential vaccines. From 11 March 2021, several European countries temporarily suspended the use of the Oxford–AstraZeneca vaccine amid reports of blood clot events and the death of a vaccinated person, despite the European Medicines Agency (EMA) and the World Health Organization’s assurance that there was no indication that vaccination was linked. This study aimed to identify and analyse the thrombotic adverse reactions associated with the Oxford–AstraZeneca vaccine. This was a retrospective descriptive study using spontaneous reports submitted to the EudraVigilance database in the period from 17 February to 12 March 2021. There were 54,571 adverse reaction reports, of which 28 were associated with thrombotic adverse reactions. Three fatalities were related to pulmonary embolism; one fatality to thrombosis. With 17 million people having had the AstraZeneca vaccine, these are extremely rare events The EMA’s Pharmacovigilance Risk Assessment Committee (18 March 2021) concluded that the vaccine was safe, effective and the benefits outweighed the risks. Conducting further analyses based on more detailed thrombotic adverse event reports, including patients’ characteristics and comorbidities, may enable assessment of the causality with higher specificity.

Abatacept in rheumatoid arthritis and the risk of cancer: a world observational post-marketing study

Rheumatology ◽  
2019 ◽  
Vol 59 (9) ◽  
pp. 2360-2367
Author(s):  
Sibylle de Germay ◽  
Haleh Bagheri ◽  
Fabien Despas ◽  
Vanessa Rousseau ◽  
François Montastruc
Keyword(s):  
Adverse Effects ◽  
Individual Case ◽  
World Health ◽  
Biologic Dmards ◽  
Global Database ◽  
Non Melanoma Skin Cancer ◽  
Increased Risk ◽  
Specific Cancer ◽  
Post Marketing ◽  
Risk Of Cancer

Abstract Objectives We aimed to investigate whether abatacept used in patients for RA was associated with an increased risk of reporting overall cancer and specific cancers, including breast, lung, lymphoma, melanoma and non-melanoma skin cancer when compared with other biologic DMARDs (bDMARDs). Methods We performed an observational study within VigiBase, the World Health Organization’s global database of individual case safety reports, from 2007 to 2017 to compare the cases of cancer reported in RA patients exposed to abatacept with those reported in RA patients exposed to other bDMARDs. We conducted disproportionality analyses allowing the estimation of reporting odds ratios (RORs) with 95% CIs of the exposure odds among spontaneous reporting of cancers to the exposure odds among other reported adverse effects. Results We identified 15 846 adverse effects reported in RA patients who received abatacept and 290 568 adverse effects reported in RA patients treated with other bDMARDs. Compared with other bDMARDs, the use of abatacept was not associated with an increased risk of reporting cancer overall [ROR 0.98 (95% CI 0.91, 1.05)]. Analyses by specific cancer sites showed a significantly increased ROR for melanoma [1.58 (95% CI 1.17, 2.08)], but not for other specific cancer sites. Conclusion Compared with other bDMARDs, exposure to abatacept in RA patients was only significantly associated with an increased risk of reporting melanoma. This increased risk is consistent with the properties of abatacept (CTLA-4 agonist) since it has an opposite action than ipilimumab, an antibody that blocks CTLA-4 and is approved for the treatment of malignant melanoma. Trial registration ClinicalTrials.gov (http://clinicaltrials.gov), NCT03980639.

scholarly journals Safety of Remdesivir and Tocilizumab in COVID-19 Treatment

2020 ◽  
Vol 8 (3) ◽  
pp. 160-162
Author(s):  
Article Editorial
Keyword(s):  
Adverse Reactions ◽  
Safety Data ◽  
Individual Case ◽  
Federal State ◽  
Symptomatic Therapy ◽  
Medicinal Products ◽  
Treatment Protocols ◽  
Global Database ◽  
Life Threatening ◽  
The Russian Federation

An important part of treating patients infected with SARS-CoV-2 is to ensure effective pathogenetic and symptomatic therapy before life-threatening complications, such as pneumonia, acute respiratory distress syndrome, or sepsis begin to develop. Current COVID-19 treatment protocols often use remdesivir and tocilizumab, though safety data on these drugs are insufficient. Therefore, experts of the Centre for Evaluation of Medicinal Products’ Safety of the Federal State Budgetary Institution “Scientific Centre for Expert Evaluation of Medicinal Products” of the Ministry of Health of the Russian Federation studied adverse reactions to remdesivir and tocilizumab, which are registered in the VigiBase (as of August 27, 2020), the global database of individual case safety reports.

scholarly journals Zolpidem for Insomnia: A Double-Edged Sword. A Systematic Literature Review on Zolpidem-Induced Complex Sleep Behaviors

2021 ◽  
pp. 025371762199237
Author(s):  
Niti Mittal ◽  
Rakesh Mittal ◽  
M. C. Gupta
Keyword(s):  
Adverse Reactions ◽  
Case Reports ◽  
Case Series ◽  
Eligibility Criteria ◽  
Study Objective ◽  
Spontaneous Reports ◽  
Cochrane Database ◽  
Sleep Behaviors ◽  
Therapeutic Doses ◽  
Favorable Side Effect Profile

Background: Being a nonbenzodiazepine, zolpidem is believed to have a favorable side-effect profile and is widely prescribed for insomnia. However, in the past few years, numerous neuropsychiatric adverse reactions, particularly complex sleep behaviors (CSBs), have been reported with zolpidem. Objective: To conduct a systematic review of zolpidem-associated CSBs. Data Sources: An electronic search was conducted using MEDLINE, Embase, PubMed, and Cochrane database of systematic reviews to extract relevant articles till July 2020. Study Eligibility Criteria: Any type of literature article (case report, case series, and observational or interventional study) reporting CSBs associated with zolpidem. Results: In this review, we present aggregate summarized data from 148 patients presenting with zolpidem-induced CSBs (79 patients from 23 case reports and 5 case series; 69 patients out of 1454 taking zolpidem [4.7%] from three observational clinical studies). Various types of CSBs associated with zolpidem were reported, most common being sleepwalking/somnambulism and sleep-related eating disorder. On causality assessment, around 88% of cases were found to have a probable association with zolpidem. Limitations: Extraction of data from observational studies and spontaneous reports, due to nonavailability of any randomized controlled trials relevant to the study objective. Conclusion and Implication of Key Findings: Zolpidem-induced CSBs, although not very common, may develop when the drug is used at therapeutic doses for insomnia. Doctors need to be alert to monitor such adverse effects of zolpidem and exercise caution while prescribing it.

scholarly journals Characteristics of interstitial lung disease in patients from post-marketing data on metastatic breast cancer patients who received abemaciclib in Japan

Breast Cancer ◽  
2021 ◽  
Author(s):  
Yucherng Chen ◽  
Satoshi Noma ◽  
Yoshio Taguchi ◽  
Masashi Takahashi ◽  
Junji Tsurutani ◽  
...  
Keyword(s):  
Interstitial Lung Disease ◽  
Lung Disease ◽  
Group Performance ◽  
Eastern Cooperative Oncology Group ◽  
Age Distribution ◽  
Metastatic Breast ◽  
Advanced Age ◽  
Spontaneous Reports ◽  
Post Marketing ◽  
Marketing Data

Abstract Background This study evaluated characteristics of patients treated with abemaciclib and diagnosed with interstitial lung disease (ILD), using 12-month post-marketing data from the real-world setting in Japan. Methods Spontaneous reports of adverse events in patients receiving abemaciclib were collected regularly from healthcare providers (HCPs) from November 30, 2018, to November 29, 2019. Detailed follow-up was requested on suspected ILD cases via questionnaires and/or interviews. Radiological images (when available) were reviewed by an ILD adjudication committee of specialists. The age distribution of patients prescribed abemaciclib in Japan was estimated based on insurance claims data. Results Of 4700 patients estimated to be exposed to abemaciclib, 82 cases of ILD were reported (46 serious, 13 fatal). Most (91%) had ≥ 1 symptom at diagnosis, commonly dyspnea/shortness of breath (59%), cough (44%), and/or fever (37%). The majority (68%) received steroid therapy (24 [56%] recovered/recovering; 5 [12%] not recovered; 13 [30%] deaths, 1 [2.3%] unknown). No specific imaging patterns or sites of predilection were identified, but a diffuse alveolar damage (DAD) pattern was observed at outcome in 3 of 4 evaluated fatal cases (16 in total evaluated). Features of fatal cases included advanced age, pre-existing interstitial change, and advanced Eastern Cooperative Oncology Group Performance Status. Conclusion Advanced age and a DAD pattern were identified as potential risk factors for cases with poorer outcomes, as previously reported for drug-induced ILD. HCPs should consider the benefit–risk profile when prescribing abemaciclib, informing patients of risks and regularly monitoring treated patients to ensure early detection and treatment of ILD.

scholarly journals Coadministration of tizanidine and ciprofloxacin: a retrospective analysis of the WHO pharmacovigilance database

2021 ◽  
Author(s):  
Annette Rudolph ◽  
Hendrike Dahmke ◽  
Hugo Kupferschmidt ◽  
Andrea Burden ◽  
Stefan Weiler
Keyword(s):  
Real World ◽  
Safety Issue ◽  
Demographic Data ◽  
Fatal Outcome ◽  
Individual Case ◽  
World Health ◽  
Global Database ◽  
The Usa ◽  
Pharmacovigilance Database ◽  
The Impact

Abstract Purpose Tizanidine, an alpha-adrenergic substance with antinociceptive and antihypertensive effects, is extensively metabolized via cytochrome P450 (CYP) 1A2. Therefore, coadministration with potent CYP1A2 inhibitors, such as ciprofloxacin, is contraindicated. However, both drugs are broadly utilized in various countries. Their concomitant use bears an inherent high risk for clinically significant symptoms, especially in multimorbid patients experiencing polypharmacy. This study aims to investigate the impact of coadministration of tizanidine and ciprofloxacin using real-world pharmacovigilance data and to raise awareness of this potentially underestimated safety issue. Methods We conducted a retrospective study including Individual Case Safety Reports (ICSR) registered until March 1, 2017, in the World Health Organization (WHO) global database. Demographic data, drug administration information, the course of the adverse drug reaction (ADR), its severity, and outcomes were analyzed for cases reporting ciprofloxacin comedication. Results In 91 (2.0%) of the identified 4192 worldwide ICSR on tizanidine, coadministration of ciprofloxacin was reported. Most of the patients were female (n = 59, 64.8%) with a median age of 54 years (range 13–85 years). The countries contributing most reports were the USA (n = 54, 59.3%) and Switzerland (n = 16, 17.6%). ADRs reported most often affected the nervous system and the cardiac function, especially with large tizanidine doses or drugs with CNS and cardiovascular depressant effects. In two cases, a fatal outcome was reported. Conclusion Despite the existing formal contraindication, the concomitant use of tizanidine and ciprofloxacin can be observed in real-world clinical practice. Reactions mainly affected the central nervous and the cardiovascular system resulting in potentially severe adverse effects. The concomitant use of tizanidine and ciprofloxacin should absolutely be avoided.

Ibuprofen and risk of hypoglycemia in diabetic and non-diabetic consumers: analysis of international pharmacovigilance data

2021 ◽  
Vol 9 (1) ◽  
pp. 5
Author(s):  
Mulugeta Russom ◽  
Filipos Yohannes ◽  
Abel Tekle ◽  
Ruth Ghirmay
Keyword(s):  
Individual Case ◽  
Causal Link ◽  
Epidemiological Evidence ◽  
Global Database ◽  
Bradford Hill ◽  
Bradford Hill Criteria ◽  
History Of ◽  
Hill Criteria ◽  
Time To Onset ◽  
Totality Of Evidence

Introduction: Ibuprofen was associated with hypoglycemia in a single published case report in a diabetic patient. Ibuprofen, however, has never been associated so far with hypoglycemia in previously healthy non-diabetic individuals and thus, it is not listed as adverse effect in its summary of product characteristics approved by major regulatory authorities. Objective: This study was conducted to assess the causal relationship between ibuprofen and hypoglycemia in diabetic and non-diabetic individuals. Materials and Methods: Analysis of the literature and the WHO global database of individual case safety reports, VigiBase, was made to explore evidence on the association of ibuprofen and hypoglycemia. The unpublished data and the currently availablepublished toxicological, biological, clinical and epidemiological evidence, if any, was systematically organized using Austin Bradford Hill criteria, causality assessment framework, to assess the causal link between ibuprofen and hypoglycemia. Results: In VigiBase, there were 125 cases of hypoglycemia associated with ibuprofen, reported from 19 countries. About 50% had history of diabetes. Ibuprofen was reported as sole suspect in 36.8% of the cases and the only drug administered in18.4%. Hypoglycemia resolved following discontinuation of ibuprofen in 21.6% and recurred in three patients with rechallenge. Outcome was fatal in 10.5%. Where ibuprofen was solely administered, median time-to-onset of hypoglycemia was one-day following administration of the drug. In an experimental study, a significant decrease in blood glucose level was observed at a higher dose of ibuprofen compared to a low-dose. Conclusion: Currently available totality of evidence reflects a possible causal association between ibuprofen and hypoglycemia that need to be substantiated with further studies.

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.

Sign in / Sign up

Export Citation Format

Share Document