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July 8, 2005 -- The
The change reflects a , a condition in which blood flow is blocked to the optic nerve, states an FDA news release.
Tens of millions of men worldwide have used the drugs. The reported vision problems have been extremely rare.
FDA's Advice for Patients
The FDA advises patients to stop taking these medicines and call a doctor or health care provider right away if they experience sudden or decreased vision loss in one or both eyes.
"Further, patients taking or considering taking these products should inform their healthcare professionals if they have ever had severe loss of vision, which might reflect a prior episode of NAION. Such patients are at an increased risk of developing NAION again," says the FDA.
"At this time, it is not possible to determine whether these oral medicines for erectile dysfunction were the cause of the loss of eyesight or whether the problem is related to other factors such as high blood pressure or diabetes, or to a combination of these problems," says the FDA.
The new labeling information is available along with additional information for health care providers and consumers online.
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