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New Warnings for Avandia® (rosiglitazone)

January 6, 2006 - GlaxoSmithKline and FDA notified healthcare professionals about post-marketing reports of new onset and worsening diabetic macular edema for patients receiving rosiglitazone. Macular edema typically occurs in association with diabetic retinopathy, although it is more likely to occur as retinopathy progresses. Risk factors for macular edema include duration of diabetes, presence of retinopathy, hypertension, and poor glycemic control. Symptoms suggestive of macular edema include blurred or distorted vision, decreased color sensitivity, and decreased dark adaptation. In the majority of these patients, peripheral edema was also reported. In some cases, the macular edema resolved or improved following discontinuation of therapy and in one case, macular edema resolved after dose reduction.

Patients being treated with Avandia® or Avandamet® should contact their physician with any concerns regarding this new information.

As always, pharmacies and members can contact the RxAmerica Customer Service Desk at 1-800-770-8014 if they have any questions about this new drug information.