Viagra Blindness
June 30, 2005 07:14

More than 13 months before a scientific journal reported that Viagra had been linked to a rare form of blindness in some men, a Food and Drug Administration safety officer made the same observation from monitoring adverse event reports and told her supervisors that doctors and patients should be warned of the findings. Her recommendation was well received, she told congressional investigators, but nothing happened. The FDA issued no public notice or proposed changes to the Viagra label. That came only following widespread publicity last month about the journal article and public concerns about the possible blindness-Viagra link. The safety officer's experience was outlined in a letter last week to FDA Acting Commissioner Lester M. Crawford from Sen. Charles E. Grassley (R-Iowa), who said the agency had moved far too slowly on an emerging safety concern.

Marc Kaufman, The Washington Post, 07/01/2005 For complete story, see http://www.washingtonpost.com/wp-dyn/content/article/2005/06/30/AR2005063001419.html