The Role of Disproportionality Analysis of Pharmacovigilance Databases in Safety Regulatory Actions: a Systematic Review

Dias, Patrícia; Penedones, Ana; Alves, Carlos; Ribeiro, Carlos Fontes; Marques, Francisco Batel

doi:10.2174/1574886310666150729112903

Cited by 26 publications

(19 citation statements)

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“…Supporting Information Table S1, which is available online, defines calculation of ROR and its 95% confidence interval (CI). 16 An ROR with a 95% CI that not encompass 1.0 suggests "statistical significance," 17 and it has been suggested that an ROR greater than 4.0 indicates a "large" effect size. Secondary analyses were performed by selecting D-penicillamine as a positive control (because this drug is known to be associated with the induction or exacerbation of MG) 18 and acetaminophen as a negative control.…”

Section: Discussionmentioning

confidence: 99%

“…The main disproportionality explored the reporting odds ratio (ROR) of reporting MG (relative to all other ADRs) for statins. Supporting Information Table S1, which is available online, defines calculation of ROR and its 95% confidence interval (CI) . An ROR with a 95% CI that not encompass 1.0 suggests “statistical significance,“ and it has been suggested that an ROR greater than 4.0 indicates a “large” effect size.…”

Section: Methodsmentioning

confidence: 99%

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Statin‐induced myasthenia: A disproportionality analysis of the WHO's VigiBase pharmacovigilance database

et al. 2019

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Background Statins have been linked to myasthenia gravis (MG) in recent case reports. However, MG is not currently listed as an adverse drug reaction (ADR) in the summary of product characteristics. Methods We performed case/noncase analyses in VigiBase® (the World Health Organization international database of suspected ADR) to identify a signal of MG (expressed as the reporting odds ratio [ROR] and its 95% confidence interval [CI]) for statins. Results A total of 3967 reports mentioned MG. Of these, 169 were suspected to be statin‐induced. A disproportionality signal was found for MG and statins use (ROR [95%CI] = 2.66 [2.28–3.10]). Conclusions The present disproportionality analysis revealed a possible drug safety signal linking MG and statins. This potential signal is weak, and is offset by the cardiovascular benefits of statins. Clinicians should be aware of this potential ADR, because it may require consideration of statin withdrawal or treatment of MG.

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Section: Discussionmentioning

confidence: 99%

Section: Methodsmentioning

confidence: 99%

Statin‐induced myasthenia: A disproportionality analysis of the WHO's VigiBase pharmacovigilance database

et al. 2019

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“…We further downgraded the quality of evidence due to reporting bias because very small proportion of primary studies that examined benefits of atypical antipsychotics also examined drug-induced QT prolongation. Retrospective post-marketing case reports collection is biased because the reporting depends on clinician opinion regarding the association between ventricular tachycardia and administration of antipsychotic drugs (109).…”

Section: Discussionmentioning

confidence: 99%

“…(114,115,120). Proactive technologically advanced pharmacovigilance applications should be implemented to decrease the risk of drug-induced QT prolongation and cardiac arrhythmias (109,(121)(122)(123)(124).…”

Section: Discussionmentioning

confidence: 99%

Effects of atypical antipsychotic drugs on QT interval in patients with mental disorders

Aronow¹,

Shamliyan²

2018

Ann. Transl. Med.

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“…A recent systematic review highlighted that only a minority of studies aimed at confirming or supporting previous regulatory decisions on a given safety aspect [52], thus strengthening the aforementioned concept that DAs do not usually support, on their own, regulatory actions but must be integrated with other data sources.…”

Section: Investigate the Likelihood Of Drug-drug Interactionsmentioning

confidence: 99%

Evolving Roles of Spontaneous Reporting Systems to Assess and Monitor Drug Safety

Raschi¹,

Moretti²,

Salvo³

et al. 2019

Pharmacovigilance

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This chapter aims to describe current and emerging roles of spontaneous reporting systems (SRSs) for assessing and monitoring drug safety. Moreover, it offers a perspective on the near future, which entails the so-called era of Big Data, keeping in mind both regulator and researcher viewpoints. After a panorama on key data sources and analyses of post-marketing data of adverse drug reactions, a critical appraisal of methodological issues and debated future applications of SRSs will be presented, including the exploitation and challenges in evidence integration (i.e., merging and combining heterogeneous sources of data into a unique indicator of risk) and patient's reporting via social media. Finally, a call for a responsible use of these studies is offered, with a proposal on a set of minimum requirements to assess the quality of disproportionality analysis in terms of study conception, performing and reporting.

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The Role of Disproportionality Analysis of Pharmacovigilance Databases in Safety Regulatory Actions: a Systematic Review

Abstract: It was not found any safety signal issued by drug regulatory agencies exclusively generated by DA. More research devoted to this issue is needed, since the value of these methods on drug safety signaling and their impact on drug regulation actions remains to be established.

Cited by 26 publications

References 0 publications

Statin‐induced myasthenia: A disproportionality analysis of the WHO's VigiBase pharmacovigilance database

Statin‐induced myasthenia: A disproportionality analysis of the WHO's VigiBase pharmacovigilance database

Effects of atypical antipsychotic drugs on QT interval in patients with mental disorders

Evolving Roles of Spontaneous Reporting Systems to Assess and Monitor Drug Safety

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