An evaluation of potential signals for ventricular arrhythmia and cardiac arrest with dolasetron, ondansetron, and granisetron in the fda combined spontaneous reporting system/adverse event reporting system

This analysis detected a potential signal for ventricular arrhythmiasand cardiac arrest with dolasetron, but not with ondansetron or granisetron. However, there are limitations of a PRR analysis, which include only measuring cases that have been reported, providing relative frequencies instead of actual rates, and not providing information on the severity of adverse events or causal relationships. In addition, our analysis does not include consideration of concomitant medications, and only 2 search terms were used. Errors in identifying potential signals may also include confounding factors, such as the underlying disease, potential confusion with reporting under trade and generic names, and potential multiple reporting of the same case.