Infusion pump technology for treating diabetes and pain management might pose special risks for adolescent patients, a 10-year Food and Drug Administration analysis of 1,647 medical device adverse event reports in patients aged 12–21 years suggests.
Prompted by five adolescent death reports associated with the use of insulin pumps during 2005, the agency conducted a search of its own medical device adverse events reports database for all those related to either insulin pumps or patient-controlled analgesia (PCA) pumps for adolescents from Jan. 1, 1996, through Dec. 31, 2005. Included are 1,594 reports for insulin pumps and 53 for PCA pumps, with 13 deaths in the former and 5 for the latter.
“[Adolescents] deserve careful consideration of risk and benefit for use of device technology. Studies need to further identify safety problems in this age group,” said Dr. Judith U. Cope of the FDA's Division of Postmarket Surveillance and her associates (Pediatrics 2008;121:e1133–8).
However, pediatric endocrinologist Dr. Francine R. Kaufman sees the insulin pump part of the article as “an example of reporting bias” because no equivalent data are included about insulin injection regimens or the risks of diabetes itself in adolescents.
“There is evidence in the pediatric community of reduction in hypoglycemia, improvement in [hemoglobin] A1c, improvement in quality of life measures with pump use. Insulin pump therapy allows for a better outcome for those children appropriately selected and willing and able to manage diabetes,” Dr. Kaufman, professor of pediatrics at the University of Southern California and director of the Comprehensive Childhood Diabetes Center and head of the Center for Endocrinology, Diabetes, and Metabolism at Childrens Hospital Los Angeles, said in an interview.
The number of insulin pump adverse event reports to the FDA for adolescents increased annually over the 10-year period. There were 1,038 injuries, 528 device malfunctions, 13 deaths, and 15 events classified as “other.”
Since 2003, a greater proportion of the reports were for patient injuries than for device malfunctions. Of the 499 reports in 2005, 76% were patient injuries and 22% were device malfunctions. Deaths made up 1%, and the remaining reports were classified as other.
Of the 13 insulin pump-related deaths over the period, 5 were related to either hyperglycemic or hypoglycemic complications, 3 to diabetic ketoacidosis, 1 to seizure, and 1 to coma; 3 death reports did not indicate a cause.
Of the total, 987 (62%) reported episodes of hyperglycemia, 47% indicated the patient had diabetic ketoacidosis. Of the 987 hyperglycemia reports, 7% concerned underinfusion. There were some reports of the device's need for repair, replacement, or removal, and also of device failure and/or failure to deliver.
Another 167 (10.5%) reports involved patient and device problems with hypoglycemia or overdelivery of insulin. A small number of reports were coded as incorrect use of the device, problem with self-activating key and overbolusing, error message, and alarm problems. The problem was coded as unknown for 60 of the 167 reports.
Special adolescent issues were identified in 6% (102) of the reports, including 82 resulting in hospitalization. The top three of these involved education, noncompliance, and problems during sports or other activities. Four of the reports indicated risk-taking behaviors, including two cases of insulin overbolusing that were believed to be suicide attempts. Three deaths occurred when there was no parental supervision.
“An increased risk for hypoglycemic complications may occur with binge drinking of alcohol,” the investigators said.
Most of the 53 PCA pump-related events occurred in patients using the devices to treat pain associated with orthopedic conditions, cancer, sickle cell disease, and pregnancy-related events; there were 19 injuries, 21 device malfunctions, and 8 other events.
In 51% of the reports, the patient received an excess dose of medication, and in 12 of those 27 reports the patient had respiratory depression and unresponsiveness requiring ventilation and/or Narcan administration. Two patients tampered with the pump and removed morphine from the device, and one smoked marijuana while using the pump.
To report device-related problems, visit www.fda.gov/medwatch
Insulin pump therapy allows for a better outcome in appropriately selected children who are able to manage diabetes. DR. KAUFMAN