Diabetes Drug Avandia Causing Macular Edema
The FDA alerted Medwatch about numerous reports that Avandia, a diabetes drug manufactured by GlaxoSmithKline, has been causing a swelling at the back of the eye known as macular edema.
# GlaxoSmithKline Plc's Avandia diabetes drug has been linked to swelling in the back of the eye, which can reduce vision, U.S. regulators said.
# The Food and Drug Administration sent an e-mail notice today about the complication, known as macular edema, to about 54,000 subscribers of MedWatch, the agency's alert system.
# The FDA also forwarded a letter that Glaxo sent last month to doctors, saying the company received reports of both new and worsening cases of swelling in people taking Avandia.
# People with diabetes already are at higher risk of eye complications because of the disorder, which results in the blood vessels at the back of the eye, or retina, becoming leaky and swelling.
# European regulators last month also said they are reviewing macular edema reports in people using Avandia and Takeda Pharmaceutical Co.'s similar Actos drug.
Filed under Eye Treatment
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