The role of adverse event reporting in the FDA response to a multistate outbreak of liver disease associated with a dietary supplement

Public Health Reports

Volumn 130, Issue 5, 2015, Pages 526-532

  Klontz, Karl C ^a   DeBeck, Heidi J ^a   LeBlanc, Pamela ^a   Mogen, Kathryn M ^a   Wolpert, Beverly J ^a   Sabo, Jonathan L ^a   Salter, Monique ^a   Seelman, Sharon L ^a   Lance, Susan E ^a   Monahan, Caitlin ^a   Steigman, David S ^a   Gensheimer, Kathleen ^a  

^a CENTER FOR DRUG EVALUATION AND RESEARCH   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

4 METHYL 2 HEXYLAMINE; AEGELINE; ALKALOID DERIVATIVE; ANOREXIGENIC AGENT; OXYELITE PRO; PERFORMANCE ENHANCING SUBSTANCE; UNCLASSIFIED DRUG; 1,3-DIMETHYLAMYLAMINE; AMIDE; AMINE; ANTIOBESITY AGENT;

ADULT; ARTICLE; DIET SUPPLEMENTATION; DRUG SAFETY; DRUG SURVEILLANCE PROGRAM; FEMALE; FOOD AND DRUG ADMINISTRATION; HOSPITAL PATIENT; HUMAN; HYPERBILIRUBINEMIA; HYPERTRANSAMINASEMIA; LABORATORY TEST; LIVER TRANSPLANTATION; MAJOR CLINICAL STUDY; MALE; MARKET; MEDICAL RECORD REVIEW; PRIORITY JOURNAL; PRODUCT SAFETY; PUERTO RICO; TOXIC HEPATITIS; UNITED STATES; ACUTE LIVER FAILURE; CHEMICALLY INDUCED; DRUG APPROVAL; DRUG-INDUCED LIVER INJURY; EPIDEMIC; HEALTH SURVEY; INTOXICATION; LEGISLATION AND JURISPRUDENCE; MEDICINAL CHEMISTRY; MIDDLE AGED; MORTALITY; PROCEDURES; STATISTICS AND NUMERICAL DATA; YOUNG ADULT;

ADULT; ADVERSE DRUG REACTION REPORTING SYSTEMS; AMIDES; AMINES; ANTI-OBESITY AGENTS; CHEMISTRY, PHARMACEUTICAL; DIETARY SUPPLEMENTS; DISEASE OUTBREAKS; DRUG APPROVAL; DRUG-INDUCED LIVER INJURY; FEMALE; HAWAII; HUMANS; LIVER FAILURE, ACUTE; LIVER TRANSPLANTATION; MALE; MIDDLE AGED; POPULATION SURVEILLANCE; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION; YOUNG ADULT;

EID: 84940416495     PISSN: 00333549     EISSN: 14682877     Source Type: Journal    
DOI: 10.1177/003335491513000515     Document Type: Article

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