FDA Investigation

The FDA recently approved new labeling for Viagra, Levitra and Cialis regarding postmarketing reports of vision loss related to NAION (non-arteritic anterior ischemic optic neuropathy). Some of the patients suffering from NAION had underlying anatomic or vascular risk factors including: low cup to disc ratio (crowded disc), age over 50, diabetes, hypertension, coronary artery disease, hyperlipidemia and smoking. However, due to an overwhelming number of reports, the FDA is now investigating a direct relationship between erectile dysfunction medications and vision loss.

NAION is a condition triggered by blood flow blockage in the eye. The condition is painless and frequently leads to permanent blindness, usually in just one eye. Vision loss usually first appears upon awakening from a night's sleep.

As of May 18, 2005, a total of 43 cases of NAION among patients using the marketed PDE-5 inhibitors (Viagra, Cialis, Levitra) have been reported to the FDA Adverse Event Reporting System. Since Viagra's approval, 38 cases have been identified in association with sildenafil, 4 cases have been identified in association with tadalafil and one case has been identified in association with vardenafil. Thirty-six of the 43 reported cases involved visual loss, and 26 of these 36 cases reported the visual loss as continuing or permanent.

If you or a loved one have experienced any side effects from the erectile dysfunction drug Viagra, Cialis or Levitra, including sudden vision loss or sudden hearing loss, please call us at 1.800.966.4999 or fill out the form to the right of the page for immediate attention to your case.

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