Health
Officials scrutinizing risks associated with erectile dysfunction drugs
NEWS IN BRIEF — Posted June 20, 2005
The Food and Drug Administration is investigating reports of vision loss caused by non-arteritic ischemic optic neuropathy and associated with the use of drugs to treat erectile problems, according to an agency spokeswoman.
"We take this situation very seriously, and we are continuing to review it," said Crystal Rice, public affairs specialist at the agency's Center for Drug Evaluation and Research.
The agency has received 38 reports of vision loss in patients using sildenafil (Viagra), four in those using tadalafil (Cialis), and one in those using vardenafil (Levitra). A causal link, however, has yet to be shown, because studies have not shown an increase in this condition among men taking the drug.
Lilly ICOS already has added information about this development to the label of Cialis, and Pfizer is considering doing the same for it's product, Viagra. Levitra's manufacturers did not respond to requests for comment.
Public health officials also are sounding the alarm about these drugs' possible link to sexually transmitted diseases. A study authored by San Francisco Health Dept. officials and published in the June issue of the American Journal of Medicine associated their use with an increasing risk of unsafe sex as well as being diagnosed with HIV or other sexually transmitted diseases.
Note: This item originally appeared at http://www.ama-assn.org/amednews/2005/06/20/hlbf0620.htm.
