How the FDA manages drug safety with black box warnings, use restrictions, and drug removal, with attention to gastrointestinal medications

Eli D. Ehrenpreis, Arthur A. Ciociola, Prasad M. Kulkarni, Costas Kefalas, Alan Buchman, Carol Burke, Tedd Cain, Jason Connor, John Fang, Ronnie Fass, Joseph Phillips, Mark Pochapin, Paul Pockros, Philip Schoenfeld, Raj Vuppalanchi

Research output: Contribution to journalShort survey

9 Scopus citations

Abstract

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.

Original languageEnglish (US)
Pages (from-to)501-504
Number of pages4
JournalAmerican Journal of Gastroenterology
Volume107
Issue number4
DOIs
StatePublished - Apr 1 2012
Externally publishedYes

ASJC Scopus subject areas

  • Hepatology
  • Gastroenterology

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    Ehrenpreis, E. D., Ciociola, A. A., Kulkarni, P. M., Kefalas, C., Buchman, A., Burke, C., Cain, T., Connor, J., Fang, J., Fass, R., Phillips, J., Pochapin, M., Pockros, P., Schoenfeld, P., & Vuppalanchi, R. (2012). How the FDA manages drug safety with black box warnings, use restrictions, and drug removal, with attention to gastrointestinal medications. American Journal of Gastroenterology, 107(4), 501-504. https://doi.org/10.1038/ajg.2011.449