Viagra Vision Loss Concern Will Prompt Erectile Dysfunction Class Labeling, Pfizer Says
This article was originally published in The Pink Sheet Daily
Executive Summary
Pfizer's review of adverse event reports concludes there is no evidence of increased risk of non-arteritic anterior ischemic optic neuropathy – but the company is agreeing to include rare reports in labeling. Lilly reports a boost in Cialis' market share since late May, when the Viagra safety concerns came to light.
You may also be interested in...
Erectile Dysfunction Class Labeling Does Not Assert Causal Link To Vision Loss
Labeling revisions for Viagra, Levitra and Cialis will add information about NAION adverse events, but states that “it is not possible to determine whether these events are related directly to the use of PDE5 inhibitors or to other factors.”
Erectile Dysfunction Class Labeling Does Not Assert Causal Link To Vision Loss
Labeling revisions for Viagra, Levitra and Cialis will add information about NAION adverse events, but states that “it is not possible to determine whether these events are related directly to the use of PDE5 inhibitors or to other factors.”
Pfizer In Talks With FDA Over Viagra Label Update To Reflect Vision Loss
Discussions follow an FDA investigation prompted by journal article reporting 15 cases of non-arteritic anterior ischemic optic neuropathy in sildenafil patients. Pfizer said a review of 103 clinical trials found no reports of the NAION; the company has submitted 23 cases to FDA since Viagra entered the market in 1998.