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U.S. Department of Health and Human Services


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Avandamet (rosiglitazone maleate)

Avandia (rosiglitazone maleate)
Avandamet (rosiglitazone maleate/metformin HCl)

Audience: Endocrinologists, other healthcare professionals and patients
[Posted 01/05/2006] GlaxoSmithKline and FDA notified healthcare professionals about post-marketing reports of new onset and worsening diabetic macular edema for patients receiving rosiglitazone. In the majority of these cases, the patients also reported concurrent peripheral edema. In some cases, the macular edema resolved or improved following discontinuation of therapy and in one case, macular edema resolved after dose reduction.

[December 2005 - Letter - GlaxoSmithKline]