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【drug-news】FDA不良反应报告强调儿童使用胰岛素
"From January 1, 2005, through December 31, 2005, the Food and Drug Administration received 5 adolescent death reports associated with the use of insulin pumps, raising concerns about use of this device in this age group," write Judith U. Cope, MD, MPH, from the Division of Anesthesiology, General Hospital, Infection Control and Dental Devices, Office of Device Evaluation, Center for Devices and Radiological Health, Food and Drug Administration, in Rockville, Maryland, and colleagues. "To understand better the types of infusion pump–related problems in adolescents, we performed a comprehensive evaluation of insulin and patient-controlled analgesic pump–related adverse events reported for adolescents that were received by the Food and Drug Administration from 1996 to 2005."
Using the FDA's Manufacturer and User Facility Device Experience Database, the investigators searched for medical device adverse event reports from January 1, 1996, through December 31, 2005, that involved insulin pumps or patient-controlled analgesic (PCA) pumps used by patients who were aged 12 to 21 years. Demographic factors, adverse event type, patient morbidity, and potential contributory factors were extracted from report narratives.
A total of 1594 adverse event reports involved insulin pumps and 53 involved PCA pumps. Reports of insulin pump events showed 13 reported deaths, 2 reports suggesting possible suicide attempts, and several other reports of severe hypoglycemic or hyperglycemic events that appeared to be device related.
In 102 reports (6.4%) concerning insulin pumps, factors were identified that possibly contributed to the adverse event. These included problems regarding compliance, education, sports-related activities, and dropping or damaging the pump. Hospitalization occurred in 82% of cases involving insulin pumps.
Of the reports concerning PCA pumps, the patient received excessive medication in about half of cases, and some cases appeared to involve tampering and noncompliance.
"Adolescents are a special population who deserve careful consideration of risk and benefit for use of device technology," the study authors write. "Studies need to further identify safety problems in this age group."
Limitations of this study include that most adverse event reports were submitted by manufacturers; the accuracy and completeness of reports was not verified by the FDA; reports with missing age information were not captured; an inability to establish a cause-and-effect relationship of an injury or illness with the device; the often subjective and imprecise recognition of device-related events; insufficient data about patient factors including compliance, socioeconomic status, medical history, disease severity, duration of disease, history of substance abuse, years of pump use, and developmental stage of puberty; and lack of data on use of pump devices and sales in this age group to provide the denominator to calculate incidence rates of adverse events. Adverse event reports for PCA pumps also had missing data regarding the type of analgesia used, dosage, diagnosis, and severity of illness.
"Device-related adverse events that occur in this age group are likely to be underreported in the MAUDE [Manufacturer and User Facility Device Experience] database and in the published literature," the study authors conclude. "The precise rates of device-related complications should be further studied and misuse of these devices be further studied in the adolescent population. Health care practitioners, medical care facilities, and consumers are encouraged to report device-related problems through the FDA Medwatch program: www.fda.gov/medwatch.
The authors have disclosed no relevant financial relationships.
Pediatrics. 2008;121:e1133-e1138. FDA不良反应报告强调儿童使用胰岛素泵或止疼泵存在风险
May 14, 2008 — US Food and Drug Administration (FDA) adverse event reports suggest that there are risks to insulin pump and analgesic pump use in adolescents, according to the results of a retrospective study reported in the May issue of Pediatrics.
2008年5月14号 — 据发表于五月版的《儿科学杂志》上的一项回顾性研究报道，美国食品药品管理局（FDA）公布的一份不良反应报告表明青少年使用胰岛素泵和镇痛泵存在风险。
"From January 1, 2005, through December 31, 2005, the Food and Drug Administration received 5 adolescent death reports associated with the use of insulin pumps, raising concerns about use of this device in this age group," write Judith U. Cope, MD, MPH, from the Division of Anesthesiology, General Hospital, Infection Control and Dental Devices, Office of Device Evaluation, Center for Devices and Radiological Health, Food and Drug Administration, in Rockville, Maryland, and colleagues. "To understand better the types of infusion pump–related problems in adolescents, we performed a comprehensive evaluation of insulin and patient-controlled analgesic pump–related adverse events reported for adolescents that were received by the Food and Drug Administration from 1996 to 2005."
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作者:admin@医学,生命科学 2010-11-12 17:11
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