| Re: Avandamet
Avandamet is a combination of Avandia and Metformin (Glucophage). Here is a partial listing of the side effects:
Reports of hypoglycemia in patients treated with rosiglitazone and maximum metformin combination therapy were more frequent than in patients treated with rosiglitazone or metformin monotherapies. In double-blind studies, hypoglycemia was reported by 3.0% of patients receiving rosiglitazone in combination with maximum doses of metformin, by 1.3% of patients receiving metformin monotherapy, by 0.6% of patients receiving rosiglitazone as monotherapy, and by 0.2% of patients receiving placebo.
There were a small number of patients treated with rosiglitazone 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 rosiglitazone.
Edema was reported in 4.8% of patients receiving rosiglitazone compared to 1.3% on placebo, and 2.2% on metformin monotherapy and 4.4% on rosiglitazone in combination with maximum doses of metformin. Overall, the types of adverse experiences reported when rosiglitazone was used in combination with metformin were similar to those during monotherapy with rosiglitazone. Reports of anemia (7.1%) were greater in patients treated with a combination of rosiglitazone and metformin compared to monotherapy with rosiglitazone.
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, fixed-dose studies, edema was reported with higher frequency in the rosiglitazone plus insulin combination trials (insulin, 5.4%; and rosiglitazone 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 rosiglitazone (see WARNINGS, Cardiac Failure and Other Cardiac Effects).
In postmarketing experience with rosiglitazone maleate, adverse events potentially related to volume expansion (e.g., congestive heart failure, pulmonary edema, and pleural effusions) have been reported.
In postmarketing experience with rosiglitazone maleate, angioedema and urticaria have been reported rarely.
(See also GLUCOPHAGE prescribing information,
wb
| 
