Abstract

Although it is noted throughout the literature that adverse effects occur, one review of safety reporting determined clinical trials only report adverse effects between 29% (laboratory adverse effects) and 39% (clinical adverse effects) (Ioannidis, et al, 2001). It is important to keep these numbers in mind when looking at the number of drug-induced hypoglycemia cases. Seltzer’s review of the literature from 1940 to 1989 reveals 1418 documented cases of drug-induced hypoglycemia. Based on estimates of the lack of adverse effect reporting, it is unlikely that these cases were the only incidents of drug-induced hypoglycemia that occurred during this time (Seltzer, 1989). It is also reasonable to look at estimates of adverse drug effects (ADEs) in hospitalized patients. Such estimates indicate ADEs may account for between 3 and 5% of all hospital admissions (Pandit et al, 1993). In a 2006 study it was determined approximately 22% of admissions attributed to ADEs were due to hypoglycemia at a university hospital versus 23% at a community hospital (Kilbridge et al, 2006). These admissions were related to an overall admission rate attributed to ADEs of 4.4% at the university hospital and 6.2% at a community hospital (Kilbridge et al, 2006). In addition there are estimates that as many as 30% of hospitalized patients experience an ADE while in the hospital (Pandit et al, 1993). Estimates of 3 – 4.5 billion dollars, which is now outdated, just begin to attribute a cost to treating ADEs. However, the cost is probably grossly underestimated since the actual number of ADEs reported is underestimated (Pandit et al, 1993). Not only is the cost of managing an ADEs a significant issue but the risk of mortality must be considered as well. Mortality has been estimated to occur in as many as 140,000 patients each year (Pandit et al, 1993). One study looking at death due to drug-induced hypoglycemia determined a 1.3% mortality rate (Juurlink et al, 2003). The incidence and impact of drug-induced hypoglycemia should be contrasted with the incidence and impact of hypoglycemia in patients with diabetes mellitus (DM) – type 1 or type 2. For patients with type 1 DM, it is estimated that hypoglycemia, by the numbers (blood glucose less than 50 – 60 mg/dL), occurs 1 in 10 times when patients check their blood glucose (Cryer et al, 2003). While the number of asymptomatic hypoglycemia episodes is undocumented, it is estimated that patients with type 1 DM experience “an average of 2 symptomatic hypoglycemic episodes per week.and an episode of severe, at least temporarily disabling hypoglycaemia once a year” (Cryer et al, 2003). The incidence of hypoglycemia in patients with type 2 DM is more challenging. When comparing the incidence of severe hypoglycemia in patients with type 1 DM versus patients with type 2 DM being treated with insulin, estimates are anywhere from 10% to equal incidence of hypoglycemia (Cryer et al, 2003). Other studies that have tried to quantify the incidence of

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