Serious adverse events with infliximab: analysis of spontaneously reported adverse events.

Serious adverse events with infliximab: analysis of spontaneously reported adverse events. Research Abstract Details 

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Serious adverse events with infliximab: analysis of spontaneously reported adverse events. Abstract Text:

Richard A Hansen,Gerald Gartlehner,Gregory E Powell,Robert S Sandler,

BACKGROUND & AIMS: Serious adverse events such as bowel obstruction, heart failure, infection, lymphoma, and neuropathy have been reported with infliximab. The aims of this study were to explore adverse event signals with infliximab by using a long period of post-marketing experience, stratifying by indication. METHODS: The relative reporting of infliximab adverse events to the U.S. Food and Drug Administration (FDA) was assessed with the public release version of the adverse event reporting system (AERS) database from 1968 to third quarter 2005. On the basis of a systematic review of adverse events, Medical Dictionary for Regulatory Activities (MedDRA) terms were mapped to predefined categories of adverse events, including death, heart failure, hepatitis, infection, infusion reaction, lymphoma, myelosuppression, neuropathy, and obstruction. Disproportionality analysis was used to calculate the empiric Bayes geometric mean (EBGM) and corresponding 90% confidence intervals (EB05, EB95) for adverse event categories. RESULTS: Infliximab was identified as the suspect medication in 18,220 reports in the FDA AERS database. We identified a signal for lymphoma (EB05 = 6.9), neuropathy (EB05 = 3.8), infection (EB05 = 2.9), and bowel obstruction (EB05 = 2.8). The signal for granulomatous infections was stronger than the signal for non-granulomatous infections (EB05 = 12.6 and 2.4, respectively). The signals for bowel obstruction and infusion reaction were specific to patients with IBD; this suggests potential confounding by indication, especially for bowel obstruction. CONCLUSIONS: In light of this additional evidence of risk of lymphoma, neuropathy, and granulomatous infections, clinicians should stress this risk in the shared decision-making process.

Serious adverse events with infliximab: analysis of spontaneously reported adverse events. Publishing Authors By Initials

RA Hansen,G Gartlehner,GE Powell,RS Sandler,

For similar peptides: intercellular signaling peptides and proteins: cytokines: monokines: tumor necrosis factor-alpha research abstracts see: peptides: intercellular signaling peptides and proteins: cytokines: monokines: tumor necrosis factor-alpha research

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Serious adverse events with infliximab: analysis of spontaneously reported adverse events. Journal Published:

PUBLICATION TYPE: Research Support, Non-U.S. Gov

Journal: Clinical gastroenterology and hepatology : the off

VOLUME: 5

Page Numbers: 729-35

Journal Abbreviation: Clin. Gastroenterol. Hepatol.

ISSN: 1542-7714

DAY: 4

MONTH: 05

YEAR: 2007

Serious adverse events with infliximab: analysis of spontaneously reported adverse events. Information

Number of References:

LANGUAGE: eng

NlmUniqueID: 101160775

Serious adverse events with infliximab: analysis of spontaneously reported adverse events. Keywords Mesh Terms:

KEYWORDS: Tumor Necrosis Factor-alpha

MESH TERMS: antagonists & inhibitors

Chemical & Substance for Abstract: Serious adverse events with infliximab: analysis of spontaneously reported adverse events. Information

Substance Name: infliximab

Registry Number: 0

Grant and Affiliation Information for Serious adverse events with infliximab: analysis of spontaneously reported adverse events.

AFFILIATION: Center for Pharmaceutical Outcomes and Policy, Division of Pharmaceutical Outcomes and Policy, School of Pharmacy, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina 27599, USA. rahansen@unc.edu

Country: United States

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MEDLINETA: Clin Gastroenterol Hepatol

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