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 FAERS / AERS Database
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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