This article is more than 5 years old. Information may no longer be current.
FDA investigating reports of blindness from Viagra, Cialis
Click Here to Manage Email Alerts
Reports that a rare side effect of two popular erectile dysfunction drugs may cause permanent blindness are now being investigated by the Food and Drug Administration, according to news sources.
Both Viagra (sildenafil, Pfizer) and Cialis (tadalafil, Lilly ICOS) may cause non-arteritic anterior ischemic optic neuropathy (NAION) in men. A CNN report indicated the FDA is in discussions about the reported cases to determine if a problem exists with the class of drugs and to determine what, if any, labeling changes may need to be made. To date, no reports of blindness have been linked with a third erectile dysfunction drug, Levitra (vardenafil HCl, Bayer, GlaxoSmithKline, Schering-Plough).
A small case series has indicated permanent vision loss may occur as quickly as 24 hours after initial use, but these patients also had existing hypertension, diabetes, elevated cholesterol or hyperlipidemia, according to the study.
Pfizer representatives told CNN the company was in discussions with the FDA about adding a disclosure in the labeling to indicate that in rare cases men who took Viagra had developed blindness, but Pfizer reiterated there is no definitive proof linking the blindness to the drug.
In a statement on its Web site, Pfizer noted in 103 clinical trials of Viagra involving more than 13,000 patients, there were no reports of NAION.
“Outside of clinical trials, Viagra has been used by more than 23 million men worldwide over the past 7 years, and reports of visual field loss due to NAION are extremely rare,” the company said.
NAION “shares a number of common risk factors with erectile dysfunction,” according to Pfizer.
All three erectile dysfunction drug prescribing information sheets note that adverse ophthalmic events may include blurred vision, changes in color vision, conjunctivitis, eye pain, glaucoma, photophobia or watery eyes.