title: How the FDA manages drug safety with black box warnings, use restrictions, and drug removal, with attention to gastrointestinal medications.
authors.affiliation: Highland Park Hospital, NorthShore University Health System, Chicago, Illinois 60035, USA. ehrenpreis@gipharm.net
authors.forename: Eli D
authors.initials: ED
authors.lastname: Ehrenpreis
authors.forename: Arthur A
authors.initials: AA
authors.lastname: Ciociola
authors.forename: Prasad M
authors.initials: PM
authors.lastname: Kulkarni
mesh_terms: D016907:Adverse Drug Reaction Reporting Systems; D017277:Drug Approval; D004348:Drug Labeling / Q000331:legislation & jurisprudence; D004335:Drug and Narcotic Control / Q000706:statistics & numerical data*; D064420:Drug-Related Side Effects and Adverse Reactions; D005765:Gastrointestinal Agents / Q000009:adverse effects* / Q000494:pharmacology*; D005767:Gastrointestinal Diseases / Q000188:drug therapy*; D006801:Humans; D011358:Product Surveillance, Postmarketing; D012308:Risk Management / Q000379:methods*; D014481:United States; D014486:United States Food and Drug Administration
chemical_list: D005765:Gastrointestinal Agents