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FDAble, LLC Publishes Safety Signal Analysis of Torisel®

Report examines adverse reactions reported for Torisel® with emphasis on infusion site extravasation and possible FDA regulatory actions.


Glastonbury, Connecticut USA, June 15, 2011 — FDAble, LLC announced today the availability of its report, “Analysis of Torisel®: Adverse Events, Extravasation & Safety Signals.”

The U.S. Food and Drug Administration (FDA) is currently evaluating the anti-cancer agent, temsirolimus, for "Potential Signals of Serious Risks / New Safety Information..." using data collected from its Adverse Events Reporting System. This ongoing evaluation stems from reports associating temsirolimus with infusion site extravasation.

In this report:

  • We examine Torisel® adverse event cases, in particular those reporting extravasation; we assess extravasation as a potential safety signal associated with Torisel®.
  • We examine the possible role that Torisel® has played in these adverse event cases.
  • We evaluate the seriousness of the extravasation adverse reactions by examining patient outcomes reported thus far, as well as concomitantly reported adverse reactions.
  • Based on our evaluation we discuss possible forthcoming FDA actions related to Torisel® and extravasation.

Table of Contents of Report

  • Background & Summary
  • Is Extravasation a Potential Safety Signal for Torisel®?
  • Is Extravasation a Potential Safety Signal for Torisel® When Compared to Other Intravenous Anti-cancer Agents?
  • Is Torisel® Reported as the Primary Suspect in Adverse Event Cases Reporting Extravasation Cases?
  • How Serious are Patient Outcomes in Torisel®/Extravasation Adverse Event Cases?
  • What Other Adverse Reactions are Reported in Torisel®/Extravasation Adverse Event Cases?
  • Conclusions Relating to Possible FDA Actions
  • Other Materials Provided in This Report
    • An Executive Summary of our analysis of adverse event cases reporting both Torisel® and extravasation (8 pages)
    • A Business Intelligence Workbook that allows the user to interactively analyze Torisel® case information
    • An Excel Workbook containing all currently published FDA adverse event case information for Torisel® (> 1,000 cases)
  • Limitations of FDA's AERS Database
  • Notes

About FDAble

FDAble provides its users with unprecedented access to adverse event data reported to the FDA regarding drugs, medical devices, and vaccines. By furnishing the only publicly available, user-friendly adverse event search engines and automated analytical tools, FDAble allows its users to search and analyze drug-, vaccine-, and medical device-safety data in ways previously available to a select few. To search and evaluate adverse events for your medication, vaccine or medical device or for more information, visit us at www.fdable.com or call 860.368.0332.





 
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Paul Danese, Ph.D.
FDAble
93 Lincoln Drive
Suite B
Glastonbury, CT USA 06033-3066
860.368.0332
pdanese@fdable.com