United States of America - The Food and Drug Administration (FDA) has approved updated labelling for tadalafil (Cialis®), vardenafil (Levitra®) and sildenafil (Viagra®) to reflect a small number of post-marketing reports of sudden vision loss, attributed to NAION (non arteritic ischemic optic neuropathy), a condition where blood flow is blocked to the optic nerve.

FDA advises patients to stop taking these medicines and contact a doctor or healthcare provider immediately if they experience sudden or decreased vision loss in one or both eyes. Further, patients taking or considering taking these products should inform their health care 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.

In February 2005, patients at high risk of heart attacks or strokes were warned against using COX-2 inhibitors. However, for some people

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. The new labelling information is available along with additional information for healthcare providers and consumers online at:

Viagra (http://www.fda.gov/cder/consumerinfo/viagra/vIAGRA.htm)

Levitra (http://www.fda.gov/cder/drug/infopage/vardenafil/default.htm)

Cialis (http://www.fda.gov/cder/drug/infopage/cialis/default.htm)

Reference: FDA Statement, 8 July 2005 on http://www.fda.gov