The Food and Drug Administration (FDA) added the following warnings to Avandia labeling information:
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. Avandia should be discontinued if any deterioration in cardiac status occurs.
Patients with New York Heart Association (NYHA) Class 3 and 4 cardiac status were not studied during the clinical trials. Avandia is not recommended in patients with NYHA Class 3 and 4 cardiac status.
In two 26-week U.S. trials involving 611 patients with type 2 diabetes, Avandia plus insulin therapy was compared with insulin therapy alone. These trials included patients with long-standing diabetes and a high prevalence of pre-existing medical conditions, including peripheral neuropathy (34%), retinopathy (19%), ischemic heart disease (14%), vascular disease (9%), and congestive heart failure (2.5%). In these clinical studies an increased incidence of cardiac failure and other cardiovascular adverse events were seen in patients on Avandia and insulin combination therapy compared to insulin and placebo. Patients who experienced heart failure were on average older, had a longer duration of diabetes, and were mostly on the higher 8 mg daily dose 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 on combination therapy. Three of 10 patients who developed cardiac failure on combination therapy during the double blind part of the studies had no known prior evidence of congestive heart failure, or pre-existing cardiac condition. The use of Avandia in combination therapy with insulin is not indicated (see ADVERSE REACTIONS).
PRECAUTIONS:
General
Subsection revised, new text in bolded, underlined italics -
Due to its mechanism of action, Avandia is active only in the presence of endogenous insulin. Therefore, Avandia should not be used in patients with type 1 diabetes or for the treatment of diabetic ketoacidosis.
Edema: Avandia should be used with caution in patients with edema. In a clinical study in healthy volunteers who received Avandia 8 mg once daily for 8 weeks, there was a [",there was a small," deleted] statistically significant increase in median plasma volume ["(1.8 mL/kg)" deleted] compared to placebo.
Since thiazolidinediones, including rosiglitazone, can cause fluid retention, which can exacerbate or lead to congestive heart failure, ["patients at risk for heart failure (particularly those on insulin) should be monitored for signs and symptoms of heart failure (See PRECAUTIONS, Use in Patients with Heart Failure) " deleted] Avandia should be used with caution in patients at risk for heart failure. Patients should be monitored for signs and symptoms of heart failure (see WARNINGS, Cardiac Failure and Other Cardiac Effects and PRECAUTIONS, Information for Patients).
In controlled clinical trials of patients with type 2 diabetes, mild to moderate edema was reported in patients treated with Avandia, and may be dose related. Patients with ongoing edema are more likely to have adverse events associated with edema if started on combination therapy with insulin and Avandia (see ADVERSE REACTIONS).
If you or a loved one has taken Avandia and suffered side effects, please contact our office for a free evaluation.
Full Article on FDA Website:
