NDLI: Safety of Perflutren Ultrasound Contrast Agents: A Disproportionality Analysis of the US FAERS Database.

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Safety of Perflutren Ultrasound Contrast Agents: A Disproportionality Analysis of the US FAERS Database.

Content Provider	World Health Organization (WHO)-Global Index Medicus
Author	Hauben, Manfred Hung, Eric Y. Hanretta, Kelly C. Bangalore, Sripal Snow, Vincenza
Spatial Coverage	United States
Description	Country affiliation: United States Author Affiliation: Hauben M ( New York University Medical Center, New York, NY, USA.); Hung EY ( Pfizer, Incorporated, 219 East 42nd Street, New York, NY, 10017, USA.); Hanretta KC ( Pfizer, Incorporated, 219 East 42nd Street, New York, NY, 10017, USA. eric.hung@pfizer.com.); Bangalore S ( Mount Sinai School of Medicine, New York, NY, USA.); Snow V ( New York University Medical Center, New York, NY, USA.)
Abstract	INTRODUCTION: Perflutren microbubble/microsphere ultrasound contrast agents have a black-box warning based on case reports of serious cardiopulmonary events. There have been several subsequent observational safety studies. Large spontaneous reporting databases may help detect/refine signals of rare adverse events that elude other data sources/study designs. OBJECTIVE: The objective of this study was to supplement existing knowledge of the reported safety of perflutren using statistical analysis of spontaneous reports. METHODS: We analyzed information from the US Food and Drug Administration Adverse Event Reporting System using a disproportionality analysis. Analysis of overall reporting for perflutren was supplemented by subset (age, indication) analysis. A signal of disproportionate reporting (SDR) was defined as EB05 >2. RESULTS: Overall, 18/380 Preferred Terms and 1/83 Standardized Medical Queries had SDRs. Most were small (EB05 = 2-4). Back pain and flank pain were the largest SDRs followed by events compatible with signs/symptoms of hypersensitivity. The general pattern of SDRs in the subset analysis was consistent with the overall analysis. Almost all events with SDRs were literally or conceptually labeled. Except for chest pain (higher in the age <65 years subgroup) and back pain (higher in the age ≥65 years subgroup), there were no statistically significant differences between age subsets. Except for the Preferred Terms Pruritus and Urticaria and the narrow Standardized Medical Queries Ventricular tachyarrhythmia, Angioedema, Oropharyngeal allergic conditions, and Hypersensitivity (higher in the stress test subgroup), there were no statistically significant reporting differences between indication subsets. There were no SDRs associated with the major cardiovascular events of death, myocardial infarction/ischemia, angina, arrhythmias, or convulsions in any analysis. CONCLUSIONS: Our combined signal detection/evaluation analysis did not identify SDRs of novel adverse events or major cardiovascular events associated with perflutren ultrasound contrast agents. The negative results for major cardiovascular events extend previous signal evaluation exercises supporting the relative cardiovascular safety of these agents.
File Format	HTM / HTML
ISSN	01145916
Issue Number	11
Volume Number	38
e-ISSN	11791942
Journal	Drug Safety
Language	English
Publisher	Springer
Publisher Date	2015-11-01
Publisher Place	New Zealand (Aotearoa)
Access Restriction	One Nation One Subscription (ONOS)
Subject Keyword	Discipline Toxicology Adverse Drug Reaction Reporting Systems Statistics & Numerical Data Contrast Media Adverse Effects Databases, Factual Fluorocarbons Adolescent Adult Standards Aged Female Humans Male Middle Aged United States Epidemiology Young Adult Journal Article
Content Type	Text
Resource Type	Article
Subject	Toxicology Pharmacology Pharmacology (medical)

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