Replication of the Weber Effect Using Postmarketing Adverse Event Reports Voluntarily Submitted to the United States Food and Drug Administration

Hartnell, Nicole R.; Wilson, James P.

doi:10.1592/phco.24.8.743.36068

Cited by 136 publications

(90 citation statements)

References 5 publications

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“…Secondly, it may be because of Weber effect where peak of ADR reporting occurs during the initial period of post-marketing phase. 36 We also observed similar findings in other spontaneous reporting studies from Government or public charity hospitals across India. CDSCO should actively involve private hospitals/ practitioners to have more data about the newer drugs.…”

supporting

confidence: 90%

Adverse drug reactions in a tertiary care teaching hospital in India: analysis of spontaneously reported cases

Bhabhor

Patel

Vahora

et al. 2014

Int J Basic Clin Pharmacol

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Background: Epidemiological data are limited regarding clinical characteristic of adverse drug reactions (ADRs) in India. Aim: The aim was to assess ADRs with reference to the causative drugs, seriousness and their other clinical characteristics in Indian tertiary care teaching hospital. Methods: A spontaneous reporting based ADR monitoring study was conducted over a period of 2 years. The World Health Organization (WHO) definition of an ADR and its seriousness was adopted. The organ system involvement was labeled by WHO-ADR terminology. ADRs were analyzed for causality by Naranjo's algorithm, preventability by modified Schumock and Thornton's criteria and types of reactions by Rawlins and Thompson classification. Subgroup analysis was performed between serious and non-serious reactions. Results: Of the total of 135 reactions reported 111 reactions from 97 patients were included for analysis. The incidences of overall and serious ADRs were 0.25 and 0.06 per 1000 patients, respectively. The most commonly implicated organ systems were skin and appendages (52.25%). The major causative drug classes were antimicrobials (40.28%), central nervous system (23.61%) and autacoids (15.97%). About twothirds of the reactions (65.77%) were classified as probable and one-tenth (8.10%) as preventable. The factors significantly associated with serious reactions were age group 40-60 years (odds ratio [OR]: 5.51), parenteral drugs (OR: 2.96), central and peripheral nervous system disorders (OR: 5.06), body as a whole -general disorders (OR: 9.05) and acute onset reactions (OR: 52.62). Conclusion: Antimicrobials are common causative agents. Cohort study is recommended to confirm the risk factors of serious ADRs in Indian population.

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supporting

confidence: 90%

Adverse drug reactions in a tertiary care teaching hospital in India: analysis of spontaneously reported cases

Bhabhor

Patel

Vahora

et al. 2014

Int J Basic Clin Pharmacol

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“…Reported AE rates were calculated based on prescription denominators for the observed utilization periods (10,20,45,69,102, and 120 million administrations). Longitudinal changes were described and compared with AE data of the 3 major regions-the USA, EU, and Japan.…”

Section: Discussionmentioning

confidence: 99%

“…The latter observation is comparable with the``Weber eŠect,'' in which the number of spontaneously reported AEs for a medication tends to increase in the initial years after product approval and, decrease in subsequent years. 19,20 According to thè`W eber eŠect,'' the peak of AE reporting is within theˆrst 2 years of use of a drug. In the case of Gd-DTPA, the peak for non-SAE reporting was observed in theˆrst 9 years of use.…”

Section: Discussionmentioning

confidence: 99%

Safety of Gadopentetate Dimeglumine after 120 Million Administrations over 25 Years of Clinical Use

Matsumura

Hayakawa

Shimada

et al. 2013

MRMS

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“…It is widely accepted that when a drug first receives marketing authorization, there is generally a substantial increase in the spontaneous reporting of ADRs (especially during the first two years on the market), which then plateaus and eventually declines. This epidemiological phenomenon is called "Weber effect" and was repeatedly shown for non-steroideal antinflammatory drugs [63][64][65]. This aspect may be related to the increased attention of clinicians towards a novel drug and may intuitively imply that the number of new signals detected reaches a peak over time with a subsequent decline.…”

Section: Dmas: Caveatsmentioning

confidence: 90%

Data Mining Techniques in Pharmacovigilance: Analysis of the Publicly Accessible FDA Adverse Event Reporting System (AERS)

Poluzzi¹,

Raschi²,

Piccinni³

et al. 2012

Data Mining Applications in Engineering and Medicine

174

195

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Background: Acute kidney injury (AKI) is associated with signi cant increases in short-and long-term morbidity and mortality. Drug-induced AKI is a major concern in the present healthcare system. Our spontaneous reporting system (SRS) analysis assessed links between AKIs, along with patients' age, as healthcare-associated risks and administered anti-infectives. We also generated anti-infectives-related AKI-onset pro les. Method: We calculated adjusted reporting odds ratios (RORs) for reports of anti-infectives-related AKIs (per Medical Dictionary for Regulatory Activities) in the Japanese Adverse Drug Event Report database and evaluated associations between anti-infectives and age by association rule mining. We evaluated time-to-onset data and hazard types using the Weibull parameter. Results: Among 534,688 reports (submission period: April 2004-June 2018), there were 21,727 AKI events. Anti-infective treatments including glycopeptide antibacterials, uoroquinolones, third-generation cephalosporins, triazole derivatives, and carbapenems were associated with 596, 494, 341, 315, and 313 AKI incidences, respectively. Adjusted RORs of anti-infectives-related AKIs increased among older patients and were higher in anti-infective combination therapies [anti-infectives, ≥ 2; ROR, 2.75 (2.56-2.95)] than in monotherapies [ROR, 1.52 (1.45-1.61)]. In association rule mining, the number of anti-infectives and age were associated with anti-infectives-related AKI lift values (as consequent). Moreover, 48.1% of AKIs occurred within 5 days (median, 5.0 days) of anti-infective therapy initiation. Conclusion: Thus, adjusted RORs derived from our new SRS analysis indicate potential AKI risks linked to age and number of administered anti-infectives.

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Replication of the Weber Effect Using Postmarketing Adverse Event Reports Voluntarily Submitted to the United States Food and Drug Administration

Cited by 136 publications

References 5 publications

Adverse drug reactions in a tertiary care teaching hospital in India: analysis of spontaneously reported cases

Adverse drug reactions in a tertiary care teaching hospital in India: analysis of spontaneously reported cases

Safety of Gadopentetate Dimeglumine after 120 Million Administrations over 25 Years of Clinical Use

Data Mining Techniques in Pharmacovigilance: Analysis of the Publicly Accessible FDA Adverse Event Reporting System (AERS)

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