Masking by vaccines in pediatric drug safety signal detection in the <scp>EudraVigilance</scp> database

Dodd, Caitlin; Păcurariu, Alexandra; Osokogu, Osemeke U.; Weibel, Daniel; Ferrajolo, Carmen; Vo, Dang H.; Becker, Benedikt; Kors, Jan A.; Sturkenboom, Miriam

doi:10.1002/pds.4623

Cited by 4 publications

(3 citation statements)

References 19 publications

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“…Consequently, safety signals pertaining to other drugs may be concealed by the large influx of “atypical” reports. This consequence has been observed with Levothyrox® in EudraVigilance®, as it blunted—if not erased—other concomitant safety signals to be captured by automated methods [9, 36]. To circumvent this issue, but still maintain a sympathetic and benevolent ear to the complaints and frustrations of patients, we propose the creation of an auxiliary circuit on drug agencies websites, different from that of pharmacovigilance, to funnel patients' dissatisfaction and complaints to health authorities.…”

Section: Discussionmentioning

confidence: 99%

Spontaneous reporting of adverse drug reactions as an outlet for patient dismay? The case of Levothyrox® change of excipients

Romani

Fresse

Parassol‐Girard

et al. 2022

Fundamemntal Clinical Pharma

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Following minor changes of excipients of Levothyrox®, the French Pharmacovigilance Database was overwhelmed by patients' spontaneous reports of adverse drug reactions associated with the new formula. After noticing that most of these reports differed from those related to other drugs, we aimed to characterize their features and compared them with spontaneous reports associated with other chronic treatments as comparators. We randomly sampled patient reports associated with either Levothyrox® new formula (n = 200) or comparator drugs (n = 200) from March 2017 till March 2018 from the National Pharmacovigilance Database. We evaluated the number of incriminated drugs and adverse drug reactions per report and verified whether they were “expected” or not according to the Summary of Product Characteristics. Levothyrox®‐associated reports included, on average, more adverse drug reactions (8 ± 4) than comparators (2 ± 2, P < 0.01) and mentioned mostly one drug (98.5% of reports), whereas comparators mentioned two at least (P < 0.001). The quantitative distribution of adverse drug reactions per report differed quite significantly, appearing almost Gaussian for Levothyrox® whereas Poisson‐like for comparators (P < 0.0001). Age did not differ significantly in the two groups (54.2 vs. 49.7, NS), but female predominated in Levothyrox® group (94.5%) as compared with comparators (60.8%, P < 0.001). A mere third of the Levothyrox®‐associated adverse drug reactions were deemed “expected,” versus two thirds for comparators (P < 0.001). The pattern of spontaneous reports associated with Levothyrox®, whether fueled by media or influenced by social networks, appears atypical, as compared with that of comparators. Such reports, by their abundance, may impair the automatic detection of relevant concomitant signals.

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Section: Discussionmentioning

confidence: 99%

Spontaneous reporting of adverse drug reactions as an outlet for patient dismay? The case of Levothyrox® change of excipients

Romani

Fresse

Parassol‐Girard

et al. 2022

Fundamemntal Clinical Pharma

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“…We first calculated the PRR in reports concerning children only, then in the whole dataset including children and adults to examine masking of safety signals if stratification for children had not been done. We also repeated the analyses of paediatric reports while stratifying for age and sex [17]. Finally, we calculated another measurement of disproportionality-the PRR by therapeutic area (PRR-TA)-for paediatric reports.…”

Section: Signal Detectionmentioning

confidence: 99%

“…Spontaneous reports only contain information on the event and the drug of interest, not on the non-exposed events or exposure without events, so cannot be used to measure incidence rates. However, signal detection based on disproportionality analyses is still possible [15,17,18]. Since the risk of adverse events can be age specific, stratification of these analyses is recommended [19].…”

Section: Introductionmentioning

confidence: 99%

Exploratory Study of Signals for Asthma Drugs in Children, Using the EudraVigilance Database of Spontaneous Reports

et al. 2019

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Introduction As asthma medications are frequently prescribed for children, knowledge of the safety of these drugs in the paediatric population is important. Although spontaneous reports cannot be used to prove causality of adverse events, they are important in the detection of safety signals. Objective Our objective was to provide an overview of adverse drug events associated with asthma medications in children from a spontaneous reports database and to identify new signals. Methods Spontaneous reports concerning asthma drugs were obtained from EudraVigilance, the European Medicine Agency's database for suspected adverse drug reactions. For each drug-event combination, we calculated the proportional reporting ratio (PRR) in the study period 2011-2017. Signals in children (aged 0-17 years) were compared with signals in the whole population. Analyses were repeated for different age categories, by sex and by therapeutic area. Results In total, 372,345 reports in children resulted in 385 different signals concerning asthma therapy. The largest group consisted of psychiatric events (65 signals). Only 30 signals were new, with seven, including herpes viral infections, associated with omalizumab. Stratification by age, sex and therapeutic area provided additional new signals, such as hypertrichoses with budesonide and encephalopathies with theophylline. Of all signals in children, 60 (16%) did not appear in the whole population. Conclusions The majority of signals regarding asthma therapy in children were already known, but we also identified new signals. We showed that signals can be masked if age stratification is not conducted. Further exploration is needed to investigate the risk and causality of the newly found signals.

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Introduction to Pharmacovigilance

Soni,

Nandave,

Kumar

2024

Pharmacovigilance Essentials

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Masking by vaccines in pediatric drug safety signal detection in the EudraVigilance database

Cited by 4 publications

References 19 publications

Spontaneous reporting of adverse drug reactions as an outlet for patient dismay? The case of Levothyrox® change of excipients

Spontaneous reporting of adverse drug reactions as an outlet for patient dismay? The case of Levothyrox® change of excipients

Exploratory Study of Signals for Asthma Drugs in Children, Using the EudraVigilance Database of Spontaneous Reports

Introduction to Pharmacovigilance

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