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Pharmacoepidemiol Drug Saf ; 18(4): 344-8, 2009 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-19242954

RESUMO

PURPOSE: To investigate cases of febrile illnesses in patients who received propofol for sedation during gastrointestinal endoscopy. METHODS: Active case finding for patients who underwent endoscopy between 1 April and 30 May 2007 and suffered unexplained fever, chills, or myalgia within 48 hour after the procedure. We reviewed medications and clinical practices to find factors associated with the reactions. RESULTS: Seventy-four cases at eight facilities in five states were identified yielding a rate of 36 reactions per 1000 procedures, compared with a baseline rate of 0.6 per 1000. The majority of patients experienced self-limited fever (89.2%), chills (73.0%), or myalgia (63.5%). Blood samples from five patients were collected for culture; no organisms grew. All health care facilities that reported cases and fully participated in the investigation (n = 7) had received a common lot of propofol just before recognition of the first case. Bacterial endotoxin and sterility testing on unopened vials from this lot of propofol showed no abnormalities. Cases terminated after facilities stopped using the associated lot of propofol. CONCLUSIONS: We found a temporal association between a particular lot of propofol and an outbreak of febrile illnesses at several healthcare facilities performing endoscopy. When propofol is used to sedate patients for endoscopy, fever is a rare outcome and healthcare professionals should investigate clusters of these reactions. Post-procedure surveillance is important to identify possible medication reactions.


Assuntos
Endoscopia Gastrointestinal , Febre/induzido quimicamente , Hipnóticos e Sedativos/efeitos adversos , Propofol/efeitos adversos , Sistemas de Notificação de Reações Adversas a Medicamentos , Calafrios/induzido quimicamente , Rotulagem de Medicamentos , Humanos , Doenças Musculares/induzido quimicamente , Controle de Qualidade , Síndrome , Fatores de Tempo , Estados Unidos , United States Food and Drug Administration
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