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The US Food and Drug Administration’s (FDA) Mini-Sentinel Program is an important initiative to identify adverse effects of new medications during the postapproval period. The system links electronic data from a variety of health care providers so as to rapidly determine the safety of medications in use.
The system is especially useful for identifying adverse effects that might not be apparent in randomized clinical trials because they are rare, occur in patient groups not included in the trials, occur when used in settings less controlled than randomized trials, or occur in patients taking the medications for periods of time longer than the length of the trial. Nonetheless, it must be remembered that analysis of the data in this surveillance system, however rich, may suffer from the limitations of any observational study.
Katz MH. Multiple Data Sources, the Best Way to Gather Safety Information About Medications. JAMA Intern Med. 2014;174(1):151. doi:10.1001/jamainternmed.2013.11488