FDAble, LLC Publishes Safety Signal Analysis of Torisel®

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

Report discusses possible forthcoming FDA actions related to Torisel® and extravasation.

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, Torisel® (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 Torisel® with infusion site extravasation.

The FDAble report includes:

  • an examination of Torisel® adverse event cases, in particular those reporting extravasation, and an assessment of extravasation as a potential safety signal associated with Torisel®.
  • an examination of the possible role that Torisel® has played in these adverse event cases.
  • an evaluation of the seriousness of the extravasation adverse reactions made by examining reported patient outcomes, as well as concomitantly reported adverse reactions.
  • a discussion of possible forthcoming FDA actions related to Torisel® and extravasation based on the analyses described above.

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 with This Report

    ---- 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, LLC 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 of interest, or for more information, visit us at http://www.fdable.com or call 860.368.0332.


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Paul Danese, Ph.D.
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