Safety profile of antiviral medications: A pharmacovigilance study using the Italian spontaneous-reporting database

Pugi, Alessandra; Bonaiuti, Roberto; Maggini, Valentina; Mihalj, Martina; Tuccori, Marco; Leone, Roberto; Rossi, Marco; Motola, Domenico; Piccinni, Carlo; Ferrazin, Fernanda; Sottosanti, Laura; Mugelli, Alessandro; Vannacci, Alfredo; Lapi, Francesco

doi:10.2146/ajhp120665

Cited by 10 publications

(11 citation statements)

References 51 publications

(62 reference statements)

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“…These limitations might contribute to the occurrence of false signal of disproportionate reporting or alternatively true safety signals may appear without disproportional reporting . However, in the subset analysis, the presence of disproportionate reporting was associated with the update of section 4.4, implying serious events were probably often reported disproportionately …”

Section: Discussionmentioning

confidence: 99%

Characteristics of drugs safety signals that predict safety related product information update

Insani

Păcurariu

Mantel‐Teeuwisse

et al. 2018

Pharmacoepidemiology and Drug

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PurposeInvestigation of drug safety signals is one of the major tasks in pharmacovigilance. Among many potential signals identified, only a few reflect adverse drug reactions requiring regulatory actions, such as product information (PI) update. Limited information is available regarding the signal characteristics that might predict PI update following signal evaluation. The objective of this study was to identify signal characteristics associated with PI updates following signal evaluation by the European Medicines Agency Pharmacovigilance Risk Assessment Committee during 2012 to 2016.MethodsA comparative study was performed based on data from 172 safety signals. Characteristics of signals were extracted from the European Pharmacovigilance Issues Tracking Tool database. Multivariable logistic regression analysis was used to assess the relationship between signal characteristics and the decision to update the PI.ResultsMultivariable logistic regression analysis showed that the presence of evidence in multiple types of data sources (adjusted odds ratio [OR] 7.8 95% CI [1.5, 40.1]); mechanistic plausibility of the drug‐event association (adjusted OR 3.9 95% CI [1.9, 8.0]); seriousness of the event (adjusted OR 4.2 95% CI [1.3, 13.9]); and age of drugs ≤5 years (adjusted OR 3.9 95% CI [1.2, 12.7]) were associated with the decision to change the PI (P < 0.05).ConclusionsThis study identified 4 characteristics of drug safety signals that have shown to be associated with PI changes as outcome of signal evaluation. These characteristics may be used as criteria for selection and prioritization of potential signals that are more likely to necessitate product information updates.

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Section: Discussionmentioning

confidence: 99%

Characteristics of drugs safety signals that predict safety related product information update

Insani

Păcurariu

Mantel‐Teeuwisse

et al. 2018

Pharmacoepidemiology and Drug

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“…Besides, there is no reason to believe pharmacological properties of the interferon–ribavirin combination could directly explain the findings. In fact, this regimen is notoriously linked to various adverse reactions that may affect every system,34 and ranked among the top in the drug lists that could adversely cause renal failure 35…”

Section: Discussionmentioning

confidence: 99%

Association between antiviral treatment and extrahepatic outcomes in patients with hepatitis C virus infection

Hsu

Huang

et al. 2014

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201

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“…The association between biologics and adverse events (as described with SOCs used in MedDRA) was assessed through a case/non-case methodology, which yielded an estimate of the ROR for each adverse event, along with a 95% confidence interval, as a measure of disproportionality. 21,22 A ROR value >1, along with a 95% confidence interval not including 1, was the criterion used for highlighting an association between a biologic and an adverse event. The ROR allows comparing the frequency of an adverse event reported for a particular drug with the frequency of reports of the same event for all other drugs.…”

Section: Discussionmentioning

confidence: 99%

Safety profiles of adalimumab, etanercept and infliximab: a pharmacovigilance study using a measure of disproportionality in a database of spontaneously reported adverse events

2014

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Safety profile of antiviral medications: A pharmacovigilance study using the Italian spontaneous-reporting database

Abstract: Analysis of data from a large Italian database showed that, among antiviral agents, the ribavirin-interferon combination, acyclovir, valacyclovir, indinavir, and zidovudine accounted for the most serious hematologic, neuropsychiatric, and renal ADRs.

Cited by 10 publications

References 51 publications

Characteristics of drugs safety signals that predict safety related product information update

Characteristics of drugs safety signals that predict safety related product information update

Association between antiviral treatment and extrahepatic outcomes in patients with hepatitis C virus infection

Safety profiles of adalimumab, etanercept and infliximab: a pharmacovigilance study using a measure of disproportionality in a database of spontaneously reported adverse events

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