Analysis of patients with hypoglycemia and/or hyperglycemia induced by gatifloxacin

Risk factors and patient profiles

Abstract

GATIFLO^® Tablets, containing gatifloxacin (GFLX), a synthetic fluoroquinolone antibacterial agent, were launched in Japan in June 2002.
For several months after GFLX were marketed, cases of hypoglycemia and/or hyperglycemia were reported as adverse drug reactions. Thus, Emergency Safety Information statement was issued in March 2003, stipulating the contraindication of GFLX in patients with diabetes mellitus.
Risk factors for inducing blood glucose change were estimated by analyzing data collected from 89 cases with severe blood glucose change reported by March 2003. The results were as follows:
1. Of 89 cases, hypoglycemia was noted in 75 (89%) and hyperglycemia in 14 (15.7%).
2. Patients with diabeties accounted for 58 (77.3%) of hypoglycemia and 11 (78.6%) of hyperglycemia.
3. Patients 65 years or older accounted for 68 cases (90.7%) of hypoglycemia and 10 (71.4%) of hyperglycemia.
4. Among 63 cases with records on renal function, dysfunction was found in 49 (89.1%) of 55 cases of hypoglycemia, and 7 (87.5%) out of 8 cases of hyperglycemia.
Based on the above findings, “diabetes mellitus, ” “aged person, ” and “renal dysfunction” are estimated as major risk factors for blood glucose change induced by GFLX. To prevent adverse reactions related to blood glucose change, it is essential to recognize these risk factors and to administer GFLX appropriately based on statements in labeling on the package inserts.