Pfizer In Talks With FDA Over Viagra Label Update To Reflect Vision Loss
This article was originally published in The Pink Sheet Daily
Executive Summary
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.