Temporal Patterns of NSAID Spontaneous Adverse Event Reports

Wallenstein, Eric J.; Fife, Daniel

doi:10.2165/00002018-200124030-00006

Cited by 52 publications

(36 citation statements)

References 2 publications

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“…Another study by Hartnell and Wilson (25) investigating the Weber effect in the United States with respect to nonsteroidal antiinflammatory drugs showed that it occurred with all five drugs included in their report, with peak incidences of adverse events occurring in the 2nd year after each drug was introduced. A study by Wallenstein and Fife (15) showed that three of five nonsteroidal antiinflammatory drugs they studied followed a temporal pattern consistent with the Weber effect, whereas two of five did not. The influence of the Weber effect suggests that the increase in adverse events associated with gadobenate dimeglumine in our study could be attributed to epidemiologic reporting bias and may not reflect a true difference in adverse events based on the pharmacologic structure of the contrast medium.…”

Section: Discussionmentioning

confidence: 95%

“…These dates were chosen to reflect a period 2 years before and 3.5 years after a change in prime vendor contract at our institution that resulted in the substitution of gadobenate dimeglumine for gadopentetate dimeglumine. A 3.5-year period (instead of a 2-year period) after this switch was chosen to account for the Weber effect, which can be responsible for transient elevations in the rates of adverse events after introduction of a new drug or changes in use of an existing drug (13)(14)(15) and which tends to peak in the 2nd year.…”

Section: Participantsmentioning

confidence: 99%

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Effect of Abrupt Substitution of Gadobenate Dimeglumine for Gadopentetate Dimeglumine on Rate of Allergic-like Reactions

Davenport¹,

Dillman²,

Cohan³

et al. 2013

Radiology

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Purpose:To evaluate the effect of abruptly substituting gadobenate dimeglumine for gadopentetate dimeglumine on allergiclike reactions. Materials and Methods:The institutional review board approved and waived patient consent for this HIPAA-compliant retrospective study. Allergic-like reactions related to gadolinium-based contrast media were assessed 2 years before and 3.5 years after gadobenate dimeglumine was substituted for gadopentetate dimeglumine. Reaction rates and severity were compared by using x 2 tests, Fisher exact tests, odds ratios (ORs), and confidence intervals (CIs). Results:Allergic Conclusion:After gadobenate dimeglumine was substituted for gadopentetate dimeglumine, a significant transient increase occurred in the frequency of reported allergic-like reactions that demonstrated a temporal pattern suggestive of the Weber effect (a transient increase in adverse event reporting that tends to peak in the 2nd year after a new agent or indication is introduced).

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Section: Discussionmentioning

confidence: 95%

Section: Participantsmentioning

confidence: 99%

Effect of Abrupt Substitution of Gadobenate Dimeglumine for Gadopentetate Dimeglumine on Rate of Allergic-like Reactions

Davenport¹,

Dillman²,

Cohan³

et al. 2013

Radiology

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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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“…However, the diagnosis of AML may be assumed to be generally reliable because ITP patients are diagnosed and treated by specialists in hematology who are assumed to be specialists in AML compared to general practitioners. Finally, our analysis is affected by various limitations of spontaneous reports conducted in postmarketing settings, such as underreporting, the effects of publicity and media attention and the temporal relationship between drug launch and the rate of reporting (19)(20)(21)(22). Moreover, detailed information, such as the type of AML based on the FAB classification, is not included in the FAERS.…”

Section: Discussionmentioning

confidence: 99%

Association between Acute Myelogenous Leukemia and Thrombopoietin Receptor Agonists in Patients with Immune Thrombocytopenia

et al. 2013

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Objective The development of myeloid malignancies is a concern when administering thrombopoietin receptor (or the myeloproliferative leukemia virus proto-oncogene product, MPL) agonists. Progression from myelodysplastic syndrome (MDS) to acute myelogenous leukemia [AML, 9 (6.12%) AML patients among 147 MDS subjects] was reported in a clinical trial. However, only one (0.15%) case of AML among 653 immune thrombocytopenic purpura (ITP) subjects was reported. Our objective was to determine whether there is currently a safety signal in the FDA files termed Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS) for AML in ITP patients who receive MPL agonists. Methods We conducted a case-controlled study using the FAERS as a source of case and control data. We compared demographic characteristics, such as gender, age and exposure to MPL agonists between AML patients and others among ITP subjects registered between 2002 and 2011. Results Total of 4,821 ITP subjects were identified, including 62 AML patients. The number of patients treated with romiplostim and eltrombopag was 54 (1.74%) AML patients among 3,102 ITP subjects and nine (1.52%) AML patients among 594 ITP subjects, respectively. It should be noted that all AML patients were exposed to one or more MPL agonists. Another factor associated with AML was male gender. Conclusion We herein report an association between AML and MPL agonist use in ITP subjects. Due to various biases and the incompleteness of the FAERS data, further studies are warranted to determine whether the detected signal is a real risk. Physicians should not alter their prescribing behaviors based on this single preliminary analysis.

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Temporal Patterns of NSAID Spontaneous Adverse Event Reports

Abstract: The temporal patterns of adverse event reports are more complex than those described in Weber's classic report. The number of reports does not reliably rise and then fall after launch and the reporting rate does not reliably decrease with time from launch.

Cited by 52 publications

References 2 publications

Effect of Abrupt Substitution of Gadobenate Dimeglumine for Gadopentetate Dimeglumine on Rate of Allergic-like Reactions

Effect of Abrupt Substitution of Gadobenate Dimeglumine for Gadopentetate Dimeglumine on Rate of Allergic-like Reactions

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

Association between Acute Myelogenous Leukemia and Thrombopoietin Receptor Agonists in Patients with Immune Thrombocytopenia

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