Avandia Warnings & Precautions

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Avandia - Warnings & Precautions [Rosiglitazone maleate]

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).

Weight Gain:

Dose-related weight gain was seen with AVANDIA alone and in combination with other hypoglycemic agents (see Table 6). The mechanism of weight gain is unclear but probably involves a combination of fluid retention and fat accumulation.

In postmarketing experience, there have been rare reports of unusually rapid increases in weight and increases in excess of that generally observed in clinical trials. Patients who experience such increases should be assessed for fluid accumulation and volume-related events such as excessive edema and congestive heart failure.

Table 6. Weight Changes (kg) From Baseline During Clinical Trials With AVANDIA
Control Group AVANDIA
4 mg
AVANDIA
8 mg
Monotherapy Duration Median
(25 th , 75 th
percentile)

Median
(25 th , 75 th
percentile)

Median
(25 th , 75 th
percentile)
26 weeks placebo -0.9 (-2.8, 0.9) 1.0 (-0.9, 3.6) 3.1 (1.1, 5.8)
52 weeks sulfonylurea 2.0 (0, 4.0) 2.0 (-0.6, 4.0) 2.6 (0, 5.3)
Combination therapy
sulfonylurea 26 weeks sulfonylurea 0 (-1.3, 1.2) 1.8 (0, 3.1) ?
metformin 26 weeks metformin -1.4 (-3.2, 0.2) 0.8 (-1.0, 2.6) 2.1 (0, 4.3)
insulin 26 weeks insulin 0.9 (-0.5, 2.7) 4.1 (1.4, 6.3) 5.4 (3.4, 7.3)

Hematologic:

Across all controlled clinical studies, decreases in hemoglobin and hematocrit (mean decreases in individual studies 1.0 gram/ dL and 3.3%, respectively) were observed for AVANDIA alone and in combination with other hypoglycemic agents. The changes occurred primarily during the first 3 months following initiation of therapy with AVANDIA or following a dose increase in AVANDIA. White blood cell counts also decreased slightly in patients treated with AVANDIA. The observed changes may be related to the increased plasma volume observed with treatment with AVANDIA and may be dose related (see ADVERSE REACTIONS, Laboratory Abnormalities, Hematologic).