Medication safety cannot be completely ensured after drugs enter the market. The FDA has developed the AERS for postmarketing drug surveillance for voluntary reporting of ADRs. Some medications used for gastrointestinal disease have received label changes or have been removed from the market. The FDA is developing new pharmacovigilance methods such as the Sentinel System to improve safety reporting. Health-care providers need to be aware of ADRs associated with the medications they prescribe. Participation in postmarketing surveillance programs will improve safety for our patients.
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