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U.S. Department of Health and Human Services

Safety

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Avandia (rosiglitazone maleate) Tablets July 2008


Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) -- July 2008

 

The detailed view includes drug products with safety labeling changes to the BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS, or PATIENT PACKAGE INSERT/MEDICATION GUIDE sections. Deletions or editorial revisions made to these sections are not included in this summary.


Summary View

 

Sections Modified Summary of Changes to Contraindications and Warnings

WARNINGS AND PRECAUTIONS

  • Cardiac Failure
  • Myocardial Ischemia
    • Myocardial Ischemic Events in Large Long-Term Prospective Randomized Controlled Trials of Avandia
  • Congestive Heart Failure and Myocardial Ischemia During Coadministration of Avandia With Insulin
  • Weight Gain

ADVERSE REACTIONS

  • Clinical Trial Experience
    • Adult
      • In clinical trials, approximately 9,900 patients with type 2 diabetes have been treated with Avandia...
      • Short-Term Trials of Avandia as Monotherapy and in Combination With Other Hypoglycemic Agents (see Table 4)
      • Long-Term Trial of Avandia as Monotherapy: A 4- to 6-year study (ADOPT) compared the use of Avandia (n = 1,456), glyburide (n = 1,441), and metformin (n = 1,454) as monotherapy in patients recently diagnosed with type 2 diabetes who were not previously treated with antidiabetic medication... (new)
        • In ADOPT, fractures were reported in a greater number of women treated with Avandia... (new)
        • Table 5 (new)
    • Laboratory Abnormalities
      • Serum Transaminase Levels
    • Postmarketing Experience
      • ...There are postmarketing reports with Avandia of hepatitis, hepatic enzyme elevations to 3 or more times the upper limit of normal, and hepatic failure with and without fatal outcome...

WARNINGS AND PRECAUTIONS

Cardiac Failure

...Although no treatment difference in change from baseline of ejection fractions was observed, more cardiovascular adverse events were observed following treatment with Avandia compared to placebo during the 52-week study. (See Table 1.)

Myocardial Ischemia: Myocardial Ischemic Events in Large Long-Term Prospective Randomized Controlled Trials of Avandia

...For these 3 trials, analyses were performed using a composite of major adverse cardiovascular events (myocardial infarction, cardiovascular death, or stroke), referred to hereafter as MACE...

Congestive Heart Failure and Myocardial Ischemia During Coadministration of Avandia With Insulin

...The total number of patients with emergent congestive heart failure was 21 (2.4%) and 7 (1.1%) in the Avandia plus insulin and insulin groups, respectively...

Weight Gain (see text after Table 3)

In a 4- to 6-year, monotherapy, comparative trial (ADOPT) in patients recently diagnosed with type 2 diabetes not previously treated with antidiabetic medication [see Clinical Studies (14.1)], the median weight change (25th, 75th percentiles) from baseline at 4 years was 3.5 kg (0.0, 8.1) for Avandia, 2.0 kg (-1.0, 4.8) for glyburide, and -2.4 kg (-5.4, 0.5) for metformin.