Rosiglitazone side effects

List of side effects
Cardiac Failure and Other Cardiac Effects Complications with Rosiglitazone and Insulin Elderly and Diabetic population Weight Gain

Cardiac Failure and Other Cardiac Effects
AVANDIA, like other thiazolidinediones, alone or in combination with other antidiabetic agents, can cause fluid retention, which may exacerbate or lead to heart failure. Patients should be observed for signs and symptoms of heart failure. In combination with insulin, thiazolidinediones may also increase the risk of other cardiovascular adverse events. AVANDIA should be discontinued if any deterioration in cardiac status occurs. Return to top

Complications with Rosiglitazone and Insulin
In three 26-week trials in patients with type 2 diabetes, 216 received 4 mg of AVANDIA plus insulin, 322 received 8 mg of AVANDIA plus insulin, and 338 received insulin alone. These trials included patients with long-standing diabetes and a high prevalence of pre-existing medical conditions, including peripheral neuropathy, retinopathy, ischemic heart disease, vascular disease, and congestive heart failure. In these clinical studies an increased incidence of edema, cardiac failure, and other cardiovascular adverse events was seen in patients on AVANDIA and insulin combination therapy compared to insulin and placebo. Return to top

Elderly and Diabetic population
Patients who experienced cardiovascular events were on average older and had a longer duration of diabetes. These cardiovascular events were noted at both the 4 mg and 8 mg daily doses of AVANDIA. In this population, however, it was not possible to determine specific risk factors that could be used to identify all patients at risk of heart failure and other cardiovascular events on combination therapy. Three of 10 patients who developed cardiac failure on combination therapy during the double-blind part of the fixed-dose studies had no known prior evidence of congestive heart failure, or pre-existing cardiac condition. Return to top

Weight Gain
Dose-related weight gain was seen with AVANDIA alone and in combination with other hypoglycemic agents (see Table 8). The mechanism of weight gain is unclear but probably involves a combination of fluid retention and fat accumulation. Return to top