Reports of New Onset and Worsening Diabetic Macular Edema for Patients Receiving

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

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.

As part of the ongoing efforts of GlaxoSmithKline (GSK) is providing updated information to health care providers, of important new safety information regarding products containing rosiglitazone (i.e., Avandia®, Avandamet®, and coming soon in some markets, Avandaryl™). These products are anti diabetic therapies used in treating type 2 diabetes mellitus. To date, cumulative worldwide exposure is in excess of 5.3 million patients for Avandia and 769,000 patients for Avandamet.

GlaxoSmithKline has received very rare post-marketing reports of new onset and worsening diabetic macular edema for patients receiving rosiglitazone (Avandia or Avandamet). 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 oedema resolved after dose reduction.

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.

This information will be provided in all rosiglitazone (i.e., Avandia, Avandamet and coming soon in some markets, Avandaryl™) product information for prescribers and patient information leaflets.

GSK News Release

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DID YOU KNOW: Fatty Liver Predicts Heart Disease in Those with Diabetes: The risk of cardiovascular disease is "moderately increased" in type 2 diabetics with nonalcoholic fatty liver disease, according to Italian researchers. The team reports, that individuals with fatty liver disease (that wasn’t attributable to alcohol abuse) had an 84 percent high likelihood of developing cardiovascular disease. The investigators conclude that "the casual detection of nonalcoholic liver disease on an ultrasound" in type 2 diabetics should alert doctors "to the coexistence of multiple underlying cardiovascular risk factors warranting evaluation and treatment as much as the risk for advancing liver disease." Diabetes, December 2005.