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Avandia, Actos Study Sees Higher Risk of Diabetic Macular Edema

Jun 28, 2011 | Parker Waichman LLP

People taking the diabetes medications Actos or Avandia have yet another side effect to worry about - a potentially blinding eye disorder called diabetic macular edema.  Diabetics are already vulnerable for this disease, which causes damage to retinal capillaries; however, their risk can usually be reduced by keeping blood sugar levels under control.

A new study involving 100,000 diabetics in the U.K. has found that people taking either Actos or Avandia who are unable to control their blood sugar are at an increased risk of the eye disease.  The study found that 1.3 percent of those who took either Actos or Avandia developed diabetic macular edema after one year, compared to 0.2 percent of those who did not take either of the drugs. Overall, the risk of diabetic macular edema increased 3 to 6 times among people who used Actos or Avandia.

The new study, conducted by researchers from the University of Nottingham, was presented over the weekend at the American Diabetes Association’s Annual Meeting in San Diego. 

Earlier this month, sales of Actos were suspended in France and Germany after a French study found that people taking Actos for more than a year faced a higher risk of developing bladder cancer.  Shortly after that, the U.S. Food & Drug Administration (FDA) issued a Drug Safety Communication to alert the public to the Actos bladder cancer association, and mandated that information regarding this potential side effect be added to the Actos label.

Avandia’s label has included a black box warning regarding an increased heart attack risk since 2007. Last year, the FDA placed severe restrictions on the sale of Avandia because of its association with an increased risk of heart attacks and strokes.

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