Type 2 Drug Gets New Warning
According to a January 5, 2006, posting on its Web site (www.fda.gov), GlaxoSmithKline and the FDA have notified healthcare professionals about post-marketing reports of new-onset and worsening diabetic macular edema for patients receiving Avandia.
“In the majority of these cases, the patients also reported concurrent peripheral edema,” the FDA writes. “In some cases, the macular edema resolved or improved following discontinuation of therapy and in one case, macular edema resolved after dose reduction.”
In a letter to healthcare providers, Alexander R. Cobitz, MD, PhD, of GlaxoSmithKline announced that the company would be highlighting this precaution in all Avandia, Avandamet and Avandaryl product information for prescribers and patient information leaflets.
What is macular edema?
Macular edema is swelling of the retina in diabetes mellitus due to leaking of fluid from blood vessels within the macula. The macula is the central portion of the retina, a small area rich in cones, the specialized nerve endings that detect color and upon which daytime vision depends.
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