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FDA: Vision Loss Reported With ED Drug Use


 

The Food and Drug Administration has approved revised labeling for Cialis (tadalafil), Levitra (vardenafil), and Viagra (sildenafil) to reflect a small number of postmarketing reports of sudden vision loss.

The sudden loss of eyesight is attributed to nonarteritic ischemic optic neuropathy, in which blood flow is blocked to the optic nerve. It's not known if these erectile dysfunction medications cause this condition. People with a higher chance of developing this condition include those who:

▸ Have heart disease.

▸ Are older than 50 years.

▸ Have diabetes.

▸ Have high blood pressure.

▸ Have high cholesterol.

▸ Smoke.

▸ Have certain eye problems.

Patients taking these medications are advised to discontinue use and contact their physician immediately if they experience sudden vision loss or decreased vision in one or both eyes. In addition, patients taking or considering these products should inform their physician if they have ever had severe loss of vision, which could reflect a prior episode of nonarteritic ischemic optic neuropathy. Such patients have an increased risk of developing the condition again.

For additional information about labeling changes to Cialis, visit www.fda.gov/cder/drug/infopage/cialis/default.htm

For additional information about labeling changes to Levitra, visit www.fda.gov/cder/drug/infopage/vardenafil/default.htm

For additional information about labeling changes to Viagra, visit www.fda.gov/cder/consumerinfo/Viagra/Viagra.htm

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