title: Safety of antibiotic drugs in food animals: comparison of findings from preapproval studies and postapproval experience in the United States with safety information in published literature.
abstract: Antibiotics are among the most widely prescribed drugs and are generally considered safe for the target species. However, their use has been associated with various adverse toxic effects in target animals, such as allergic reactions, gastrointestinal signs, cardiovascular effects, hypoglycemia, hepatic/renal toxicity, thrombocytopenia, and anaphylaxis. This article provides a qualitative summary of the adverse events observed in target animals during the evaluation of antibiotics by the Food and Drug Administration during both preapproval and postapproval periods. As there is a marked scarcity of published data on safety of antibiotics in food animals, more research is needed in this area.
authors.affiliation: Office of Surveillance and Compliance, FDA Center for Veterinary Medicine, 7519 Standish Place, Rockville, MD 20855, USA. tomislav.modric@fda.hhs.gov
authors.forename: Tomislav
authors.initials: T
authors.lastname: Modric
authors.forename: Sanja
authors.initials: S
authors.lastname: Modric
authors.forename: Michael J
authors.initials: MJ
authors.lastname: Murphy
authors.forename: Susan J
authors.initials: SJ
authors.lastname: Bright
authors.forename: Stacey
authors.initials: S
authors.lastname: Shults
mesh_terms: D000820:Animal Diseases / Q000139:chemically induced* / Q000453:epidemiology; D000818:Animals; D000900:Anti-Bacterial Agents / Q000009:adverse effects*; D002986:Clinical Trials as Topic; D017277:Drug Approval / Q000379:methods*; D064420:Drug-Related Side Effects and Adverse Reactions; D058751:Livestock; D011358:Product Surveillance, Postmarketing; D014481:United States / Q000453:epidemiology
chemical_list: D000900:Anti-Bacterial Agents