Safety alert
date: 1/25/2006
Diabetes medication linked to vision problems and swollen legs and feet
People with type 2 diabetes who take drugs containing rosiglitazone should seek medical attention promptly if they experience this newly identified side effect: blurred or distorted vision, which may be accompanied by swollen ankles, feet, and legs.
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On Jan. 5, 2006, the Food and Drug Administration and pharmaceutical manufacturer GlaxoSmithKline issued important new safety information about the diabetes drugs Avandia (rosiglitazone) and Avandamet (rosiglitazone and metformin). Those medications reduce the blood-glucose level mainly by increasing sensitivity to the sugar-regulating hormone insulin and reducing the liver's production of glucose. Rare reports now link the drugs with new or worsening macular edema, or swelling of the retina's focal area, resulting in blurred or distorted vision. In most of those cases, patients also experienced peripheral edema, or fluid buildup in the ankles, feet, and legs, which can exacerbate or lead to heart failure. The new warning also applies to GlaxoSmithKline's diabetes drug Avandaryl (rosiglitazone and glimepiride), which the FDA approved on Nov. 23, 2005, and which will be "coming soon in some markets," according to a "Dear Health-Care Provider" letter from the drug firm posted on the FDA's Web site (www.fda.gov).
Experts we consulted advised people who take rosiglitazone to do the following:
WHAT YOU CAN DO
Experts we consulted advised people who take rosiglitazone to do the following:
- Seek medical attention without delay if you experience blurred or distorted vision, including decreased color sensitivity or reduced ability to adapt to the dark. Your physician, in consultation with your eye doctor, may decide to switch you to another drug or just lower the dosage; reports cited by GlaxoSmithKline suggest that those steps may resolve the vision problem.
- Have your eyes checked at least once a year for macular edema.
- Get a blood test for liver problems—another potential adverse effect of the medication—as often as your doctor advises. (New users should be tested before starting as well.)
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