GlaxoSmithKline and FDA notified healthcare professionals about post-marketing reports of new onset and worsening diabetic macular edema for patients receiving rosiglitazone.
Drugs Referenced:
- Avandia (rosiglitazone maleate)
- Avandamet (rosiglitazone maleate/metformin HCl)
Audience Affected: Endocrinologists, other healthcare professionals and patients
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.
To read the December 2005 letter from GlaxoSmithKline, click here. (requires Adobe Acrobat, pdf format)Source: FDA
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