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An Association Between Avandia® and Avandamet® and Vision Problems in Diabetics

MISSISAUGA, ONTARIO, CANADA -- December 23, 2005 -- Avandia(R) (rosiglitazone maleate) tablets and Avandamet(R) (rosiglitazone maleate/metformin hydrochloride) tablets are medications authorized for use in Canada to control blood sugar levels in diabetic patients whose blood sugar levels have not been controlled by diet, exercise, or other medications. GlaxoSmithKline Inc. (GSK), after discussions with Health Canada, wishes to provide Canadians with important new safety information regarding rare reports of a specific vision problem called macular edema occurring in diabetic patients who were taking Avandia or Avandamet.

Macular edema is a swelling of the retina due to fluid at the back of the eye and may be more likely to occur in people with diabetic retinopathy (a disease of the retina caused by diabetes), high blood pressure, and/or poor control of their blood sugar levels.

Advice to patients using Avandia or Avandamet:
· Your doctor may send you to an eye doctor for a consultation and may consider stopping your Avandia or Avandamet therapy. You should see your doctor if you have any of the following symptoms of visual impairment: blurred or distorted vision, decreased color sensitivity, and/or decreased ability to adapt to darker surroundings.
· If you have already been diagnosed with macular edema or diabetic retinopathy, you should see your doctor to assess whether Avandia or Avandamet treatment should be continued.
· It is very important that you do not stop taking your medication without first consulting with your doctor as an increase in blood sugar levels can cause medical problems.
· As part of a comprehensive diabetes management plan, you should get regular eye checkups.

GSK has sent a letter to Canadian health-care professionals informing them of this new safety information. GSK is working with Health Canada to revise the Canadian prescribing information for Avandia and Avandamet. If patients have questions regarding their current prescription, they are asked to contact their doctor or pharmacist. Health Canada will review this new safety information for Avandia and Avandamet and will do so for other similar drugs used for the treatment of diabetes.
Managing marketed health product-related adverse reactions depends on healthcare professionals and consumers reporting them. Reporting rates determined on the basis of spontaneously reported post-marketing adverse reactions are generally presumed to underestimate the risks associated with health product treatments. Any case of serious or unexpected adverse reactions in patients receiving Avandia or Avandamet should be reported to GlaxoSmithKline Inc. or Health Canada.


SOURCE: GlaxoSmithKline Inc.

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