Atomoxetine in the treatment of attention deficit hyperactivity disorder and suicidal ideation

Capuano, Annalisa; Scavone, Cristina; Rafaniello, Concetta; Arcieri, Romano; Rossi, Francesco; Panei, Pietro

doi:10.1517/14740338.2014.941804

Cited by 17 publications

(13 citation statements)

References 27 publications

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“…This study has a number of limitations and strengths. First of all, it is based on the spontaneous reporting system, and it is well known that it is affected by constraints that include underreporting, lack of clinical data, and improper causality attribution [ 69 , 70 ]. Considering these intrinsic limitations, we cannot rule out the presence of other information not listed in ICSRs which might have influenced the proper evaluation of each report (i.e., the lack of the date of infliximab’s administration, the dose, concomitant clinical conditions or medications).…”

Section: Discussionmentioning

confidence: 99%

Real World Data on the Utilization Pattern and Safety Profile of Infliximab Originator Versus Biosimilars in Italy: A Multiregional Study

et al. 2018

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BackgroundIn recent years, several biosimilar drugs, including those of infliximab, have obtained marketing authorization from the European Medicines Agency (EMA). Given the peculiarity of the safety profile of biological medical products (originator and biosimilars), the evaluation of their tolerability represents an important component of pre-marketing and post-marketing clinical development. For example, infliximab products may cause adverse drug reactions (ADRs) including acute infusion reactions, delayed hypersensitivity reactions, and loss of efficacy, as a direct consequence of immunogenicity. Therefore, specific contraindications, special warnings and precautions have been introduced in the infliximab Summary of Product Characteristics (SPC).ObjectiveThe aim was to assess the magnitude of preventable ADRs in individual case safety reports (ICSRs) having infliximab as a suspected drug across Italy (using the spontaneous reporting systems), and the probability of reporting infections, infusion reactions, lack of efficacy, and hypersensitivity for originator and biosimilars of infliximab.MethodsWe analyzed ADRs reported across the 2015–2017 period in the databases of five Italian regions: Campania, Lombardy, Sicily, Tuscany, and Veneto. Preventability of ADRs was assessed using the P-method. To compare the probability of reporting infections, infusion reactions, lack of efficacy, and hypersensitivity as ADRs as opposed to other types of ADRs between originator and biosimilars of infliximab, we used the reporting odds ratio (ROR). For descriptive purposes, the number of ICSRs involving infliximab, the number of infliximab vials distributed in the aforementioned Italian regions and the relative reporting rate stratified by semester were reported.ResultsFrom October 2015 to October 2017, 459 ICSRs reported infliximab as a suspected drug (222 ICSRs related to infliximab originator and 237 to infliximab biosimilars). In the same period, 81,906 vials of infliximab were distributed, resulting in a reporting rate of six ICSRs/1000 vials. Overall, 34 cases (7.41%) were categorized as preventable. The most frequently detected critical criteria were “documented hypersensitivity to administered drug or drug class,” “inappropriate prescription for patient’s underlying medical condition” and “incorrect dose.” Biosimilars had, in adjusted analyses, an increased probability of being reported as suspected in ICSRs reporting infusion reactions (ROR 4.09; 95% confidence interval [CI] 1.26–13.32) when compared to Remicade®. On the contrary, they had a decreased probability of being reported as suspected in ICSRs reporting infections or lack of efficacy (ROR 0.33; 95% CI 0.12–0.89; ROR 0.35; 95% CI 0.20–0.61).ConclusionOur study demonstrates that, along with a rapid increase in the utilization of infliximab biosimilars across Italy, there was also an increase in reporting ADRs induced by infliximab biosimilars. Of the reported ADRs, 7.4% were considered preventable. In adjusted analyses, infliximab biosimilars were shown to have ...

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Section: Discussionmentioning

confidence: 99%

Real World Data on the Utilization Pattern and Safety Profile of Infliximab Originator Versus Biosimilars in Italy: A Multiregional Study

et al. 2018

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“…It was not in the focus of our study to examine suicidal behavior, as a safety concern about ADHD drug treatment. We excluded those studies, which aim was to examine pharmacological treatment ( e.g ., atomoxetine) induced suicide in patients with ADHD, e.g ., Capuano et al[23], who present a series of cases of Italian children who experienced suicidal ideation during ADHD pharmacological therapy with atomoxetine.…”

Section: Methodsmentioning

confidence: 99%

Attention-deficit/hyperactivity disorder and suicide: A systematic review

Balázs

Keresztény

2017

WJP

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AIMTo investigate suicidality and attention-deficit/hyperactivity disorder (ADHD), this paper aims to systematically review the literature as an extension of previous reviews.METHODSWe searched five databases (Ovid MEDLINE, Psychinfo, PubMed, Scopus, Web of Science) with two categories of search terms: (1) suicide; suicidal; suicide behavior; suicide attempt; suicidal thought; and (2) ADHD.RESULTSThe search resulted 26 articles. There is a positive association between ADHD and suicidality in both sexes and in all age groups. Comorbid disorders mediate between suicidality and ADHD.CONCLUSIONRecognizing ADHD, comorbid conditions and suicidality is important in prevention.

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“…The study demonstrated no increase in the risk of sudden death associated with stimulants or atomoxetine, however, an increased risk of suicide was seen [8]. Further observational studies include case series descriptions from spontaneous reports [2,9] and published case reports on suicidal ideation and/or behaviours [10,11].…”

Section: Introductionmentioning

confidence: 99%

Use of atomoxetine and suicidal ideation in children and adolescents: Results of an observational cohort study within general practice in England

et al. 2017

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This study found no evidence of an increased risk of suicidal ideation during treatment with atomoxetine, compared to the period prior to starting treatment. Amongst age specific subgroups, this risk may change. Nonetheless, individual case assessment suggested a causal relationship in some patients, hence physicians need to be aware of the possibility of developing this event, and furthermore consider how best to detect it in this paediatric population. This study demonstrates the importance of combining quantitative statistical analyses with a qualitative case series assessment.

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Atomoxetine in the treatment of attention deficit hyperactivity disorder and suicidal ideation

Abstract: There is a need to improve our knowledge about the efficacy and safety of ATX, MPH and other drugs used in the treatment of ADHD both in children and adults during the post-marketing experience.

Cited by 17 publications

References 27 publications

Real World Data on the Utilization Pattern and Safety Profile of Infliximab Originator Versus Biosimilars in Italy: A Multiregional Study

Real World Data on the Utilization Pattern and Safety Profile of Infliximab Originator Versus Biosimilars in Italy: A Multiregional Study

Attention-deficit/hyperactivity disorder and suicide: A systematic review

Use of atomoxetine and suicidal ideation in children and adolescents: Results of an observational cohort study within general practice in England

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