International comparison of the quality of voluntary adverse event reports for cremophor-containing paclitaxel-associated anaphylaxis submitted to regulatory agencies in the United States, Europe, and Japan

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6589 Background: Serious adverse drug events (sADEs) are a significant cause of morbidity and mortality. The FDA's MedWatch program is a voluntary adverse drug reporting program. In Europe and Japan, sADE reports are rarely reimbursed. We evaluated the quality of adverse events reporting in the US, Europe, and Japan for paclitaxel-associated anaphylaxis. Hypersensitivity reactions (presumably due to the diluent cremophor) occur in up to 42% of patients receiving paclitaxel (cremophor- containing paclitaxel was licensed in 1992, a cremophor-free paclitaxel was licensed in 2005). Methods: We reviewed reports of anaphylactic reactions to paclitaxel reported between 1997–2007 contained in the FDA Adverse Event Report System (AERS). Results: Of 171 unique case reports, 34% resulted in death. Cases that resulted in death were mostly incomplete in reporting descriptions of anaphylaxis symptoms and prophylaxis/therapy drug regimens in the US, Europe and Japan. (Table) The median duration between date of event and regulatory notification was 27, 55, and 18 days for the US, Europe, and Japan respectively. Conclusions: Overall, the quality of case reports of serious anaphylaxis reactions to cremophor-containing paclitaxel was poor in the US, Europe, and Japan, despite a substantial number of these reports being associated with death. Surprisingly, among the patients receiving prophylaxis with corticosteroids, anti-histamines, and/or H2-blockers, 36% of patients still died. [Table: see text] No significant financial relationships to disclose.