Viagras label will soon mention that the drug may put some consumers at risk for nonarteritic anterior ischemic optic neuropathy (NAION).
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An article in Marchs Journal of Neuroophthalmology reported that seven patients, ages 50 to 69, experienced symptoms of NAION within 36 hours after taking Viagra (sildenafil, Pfizer). The affected patients had pre-existing hypertension, diabetes, elevated cholesterol or hyperlipidemia. The researchers concluded that Viagra may provoke NAION in patients who have an arteriosclerotic risk profile.
Pfizer has since reviewed 103 clinical trials of Viagra that included 13,000 patients. The pharmaceutical company reported that there is no evidence showing that NAION occurred more frequently in men taking Viagra than in men of similar age and health who did not take Viagra.
NAION is associated with several of the same risk factors as erectile dysfunction. These include age over 50, high blood pressure, high cholesterol and diabetes. Additionally, most of the men taking Viagra who reported symptoms of NAION had underlying anatomic or vascular risk factors associated with the condition, Pfizer says.
The company has agreed to include the report of NAION on the Viagra label. Pfizer also reports that it understands that the FDA has asked manufacturers of other erectile dysfunction medicines to include similar information on their labels.
Pfizer has since reviewed 103 clinical trials of Viagra that included 13,000 patients. The pharmaceutical company reported that there is no evidence showing that NAION occurred more frequently in men taking Viagra than in men of similar age and health who did not take Viagra.
NAION is associated with several of the same risk factors as erectile dysfunction. These include age over 50, high blood pressure, high cholesterol and diabetes. Additionally, most of the men taking Viagra who reported symptoms of NAION had underlying anatomic or vascular risk factors associated with the condition, Pfizer says.
The company has agreed to include the report of NAION on the Viagra label. Pfizer also reports that it understands that the FDA has asked manufacturers of other erectile dysfunction medicines to include similar information on their labels.
Pomeranz HD, Bhavsar AR. Nonarteritic ischemic optic neuropathy developing soon after use of sildenafil (Viagra): a report of seven new cases. J Neuroophthalmol 2005 Mar;25(1):9-13.
Vol. No: 142:7Issue:
7/15/2005
