Assessment of signals generated from spontaneously reported adverse events

Whereas in the previous article in this series approaches to signal generation were discussed, the present article will address what to do when a signal has been generated. Finding a signal heralds additional work Ð often a great deal of work Ð for the pharmacovigilance expert. In fact, a signal always needs further evaluation since, by its very nature, a signal is not actual evidence that there is something wrong with the drug concerned. Furthermore, if the signal turns out to indicate a real side e€ect, action may need to be taken, such as a drug labelling revision.