Avandia

[Rosiglitazone maleate]

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)

Text Continues Below

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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).

Ovulation:

Therapy with AVANDIA, like other thiazolidinediones, may result in ovulation in some premenopausal anovulatory women. As a result, these patients may be at an increased risk for pregnancy while taking AVANDIA (see PRECAUTIONS, Pregnancy, Pregnancy Category C). Thus, adequate contraception in premenopausal women should be recommended.
This possible effect has not been specifically investigated in clinical studies so the frequency of this occurrence is not known.

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