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FDA updates labeling on erectile dysfunction drugs to include vision loss reports
WASHINGTON — The Food and Drug Administration has approved updated labeling on three drugs for the treatment of erectile dysfunction, reflecting a small number of post-marketing reports of sudden vision loss with use of the drugs, the agency announced on its Web site.
The FDA advised patients to stop taking sildenafil, tadalafil or vardenafil if they experience sudden or decreased vision loss in one or both eyes. Patients taking these products should also tell their physician if they have ever experienced a severe loss of vision, which “might reflect a prior episode” of non-arteritic ischemic optic neuropathy, the FDA said.
The agency noted that it is not yet possible to determine if the vision loss suffered by 38 users of the drugs was related to the drug itself or whether the visual loss stemmed from other factors such as high blood pressure or diabetes.
Pfizer has stated previously that its research has concluded there is no apparent link between its drug Viagra (sildenafil) and an increased risk of blindness. The company also noted that more than 23 million men worldwide have taken Viagra since its launch 7 years ago.
Cialis (tadalafil) is distributed jointly by Eli Lilly and Icos. Levitra (vardenafil) is a joint venture of Bayer, GlaxoSmithKline and Schering-Plough.