Pharmacovigilance

Pharmacovigilance is the post-approval scientific and data gathering activities related to the detection, assessment, understanding, and prevention of adverse events or other product related problems.  Safety signals detected during postmarketing surveillance can prompt epidemiologic studies to support or refute the postmarketing trend.  With these finding then available, regulatory action along with internal corporate action can be taken if needed.

For Example - Zolpidem brand name Ambien^®

Postmarketing pharmacovigilane database contains reports of memory impairment.  These are spontaneous report by healthcare professional or individuals themselves.  There has been no definitive link between the drug use and these reports.  These reports do help to focus attention on an adverse reaction that may be out in general public, but was not seen in clinical trials when the product was being investigated prior to approval.