|
Side Effects & Drug Interactions
ADVERSE REACTIONS
In clinical trials, approximately 4,600 patients with type 2 diabetes have been treated with AVANDIA; 3,300 patients were treated for 6 months or longer and 2,000 patients were treated for 12 months or longer. Trials of AVANDIA as Monotherapy and in Combination With Other Hypoglycemic Agents: The incidence and types of adverse events reported in clinical trials of AVANDIA as monotherapy are shown in Table 7. 
Text Continues Below
There were a small number of patients treated with AVANDIA who had adverse events of anemia and edema. Overall, these events were generally mild to moderate in severity and usually did not require discontinuation of treatment with AVANDIA. In double-blind studies, anemia was reported in 1.9% of patients receiving AVANDIA compared to 0.7% on placebo, 0.6% on sulfonylureas, and 2.2% on metformin. Edema was reported in 4.8% of patients receiving AVANDIA compared to 1.3% on placebo, 1.0% on sulfonylureas, and 2.2% on metformin. Overall, the types of adverse experiences reported when AVANDIA was used in combination with a sulfonylurea or metformin were similar to those during monotherapy with AVANDIA. Reports of anemia (7.1%) were greater in patients treated with a combination of AVANDIA and metformin compared to monotherapy with AVANDIA or in combination with a sulfonylurea. Lower pre-treatment hemoglobin/ hematocrit levels in patients enrolled in the metformin combination clinical trials may have contributed to the higher reporting rate of anemia in these studies (see ADVERSE REACTIONS, Laboratory Abnormalities, Hematologic). In 26-week double-blind studies, edema was reported with higher frequency in the AVANDIA plus insulin combination trials (insulin, 5.4%; and AVANDIA in combination with insulin, 14.7%). Reports of new onset or exacerbation of congestive heart failure occurred at rates of 1% for insulin alone, and 2% (4 mg) and 3% (8 mg) for insulin in combination with AVANDIA (see WARNINGS, Cardiac Failure and Other Cardiac Effects). In postmarketing experience with AVANDIA, adverse events potentially related to volume expansion (e. g., congestive heart failure, pulmonary edema, and pleural effusions) have been reported. Page: 1 | 2 | 3 | 4 | 5 | Next >>
|
.gif)
