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July 12, 2005

Medscape Alert

Reports of Sudden Vision Loss Added to Labeling for Viagra, Cialis, Levitra

Yael Waknine;

July 8, 2005 — The U.S. Food and Drug Administration (FDA) has advised healthcare professionals via news release of a potential risk of sudden vision loss that may be attributed to use of phosphodiesterase 5 (PDE-5) inhibitors.

According to the news release, sudden vision loss in one eye due to arteritic ischemic optic neuropathy (NAION) has been reported in a small number of patients taking sildenafil citrate (Viagra, made by Pfizer, Inc.), tadalafil (Cialis, made by Lilly ICOS, LLC), and vardenafil HCl (Levitra, made by Bayer Pharmaceuticals Corp.) for the treatment of erectile dysfunction (ED).

As of May 18, the FDA has received a total of 43 postmarketing reports of ischemic optic neuropathy in patients using these drugs (sildenafil, n = 38; tadalafil, n = 4; vardenafil, n = 1). A majority of these cases (36) appear to be of the NAION subtype; in 26 of these, the loss of vision has been described as continuing or permanent.

Because many of these adverse events were reported in patients with vascular risk factors for NAION that overlap with those for ED (such as age older than 50 years, low cup to disc ratio, hypertension, diabetes, smoking, etc.), the causal role of PDE-5 inhibitors remains unclear.

The FDA notes that the clinical attributes of some of the cases (eg, a temporal relationship in 19 sildenafil cases, four tadalafil cases, and one vardenafil case; recurrent ocular symptoms suggestive of NAION in five sildenafil cases) are a cause for concern.

Patients should be advised to discontinue use of the products and seek immediate medical attention if they experience a sudden decrease/loss of vision in one or both eyes. This may be a sign of NAION, which can result in permanent loss of vision.

Patients also should be advised of risk factors for NAION (such as a previous episode, age older than 50 years, and a history of heart disease, diabetes, high blood pressure, high cholesterol, or smoking) and the potential role of vasodilators such as PDE-5 inhibitors in inciting its occurrence.

Further information concerning use of sildenafil citrate, vardenafil HCl, and tadalafil may be obtained online at: http://www.fda.gov/cder/consumerinfo/viagra/vIAGRA.htm, http://www.fda.gov/cder/drug/infopage/vardenafil/default.htm, and http://www.fda.gov/cder/drug/infopage/cialis/default.htm, respectively.

Adverse events related to the use of sildenafil citrate, vardenafil HCl, or tadalafil should be reported to the FDA's MedWatch program by telephone at 1-800-FDA-1088, by fax at 1-800-FDA-0178, online at http://www.fda.gov/medwatch, or by mail to 5600 Fishers Lane, Rockville, MD 20852-9787.

Reviewed by D. Vogin, MD

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