Use of the FDA spontaneous adverse event reporting system (SAERS), or why your MedWatch reports really do matter

Abstract

6089 Background: The purpose of this project is to demonstrate how a publicly available data source is used for safety assessments in cancer drug development and commercialization. Methods: Oxaliplatin was approved in August 2002 for second-line use in metastatic colorectal cancer. Peripheral sensory neuropathy commonly occurs with oxaliplatin, and at least 4 cases of autonomic neuropathy (with Lhermitte's sign and urinary retention), have also been reported. We searched the FDA SAERS database, which is comprised predominantly of MedWatch reports filed by physicians, for reports suggesting either of these frequent or infrequent types of neuropathy. Proportional reporting ratios (PRR) were calculated for oxaliplatin relative to other platinum compounds. PRRs > 3.0 are suggestive of a “signal”, but need a larger context to interpret. Results: Relevant PRRs as of March 21, 2003 are shown for MedDRA High Level Terms (HLT) and various Preferred Terms (PT) subsumed under the HLTs. The PRR for oxaliplatin is statistically significant and lower than for other platinum compounds for “peripheral neuropathy”, but higher for “sensory abnormalities”. Reports of urinary symptoms are few, but appear to be comparable (at the HLT) for all platinum drugs. Conclusions:Oncologists can actively contribute to the drug safety monitoring of all patients by submitting MedWatch reports to the FDA SAERS. Author Disclosure Employment or Leadership Consultant or Advisory Stock Ownership Honoraria Research Funding Expert Testimony Other Remuneration MetaWorks, Inc. MetaWorks, Inc. MetaWorks, Inc.