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Analysis of Torisel®: Adverse Events, Extravasation & Safety Signals
FDAble, May 2011, Pages: 8
The U.S. Food and Drug Administration (FDA) is currently evaluating the anti-cancer agent, Torisel®, for “potential signals of serious risks...” using data collected from its Adverse Events Reporting System. This ongoing evaluation stems from reports associating Torisel® with infusion site extravasation.
In this report:
- Torisel® adverse event cases are examined, in particular those reporting extravasation and the report assesses the possibility that extravasation is a potential safety signal.
- The report examines the possible role that Torisel® has played in these adverse event cases.
- The report analyzes the seriousness of the extravasation adverse reactions by examining patient outcomes and concomitantly reported adverse reactions.
- Based on the analysis detailed above the report comments on possible forthcoming FDA actions related to Torisel and extravasation.
The report contains 4 documents:
- An Executive Summary of the analysis of adverse event cases reporting both Torisel® and extravasation
- A Business Intelligence Workbook that allows the user to interactively analyze Torisel® case information
- An Excel Workbook that contains all currently published FDA adverse event case information for Torisel® (> 1,000 cases)
- The most recent official U.S. Prescribing Information for Torisel® (updated September, 2010)
Adverse Event Case Data include (when known):
- Patient Age
- Patient Weight
- Patient Gender
- FDA Notification Date
- Manufacturer Notification Date
- Adverse Event Date
- Patient Outcomes (death, disability, hospitalization, etc.)
- Adverse Reactions Reported
- Drug Names
- Drug Administration Routes
- Verbatim Drug Dosages
- Drug Lot Number
- Drug Dechallenge and Rechallenge Information
- Duration of Drug Therapies
- Occupation of Person Submitting the Report
Product samples
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