–June 28, 2005
Pfizer said yesterday that the company was continuing discussions with the U.S. Food and Drug Administration about labeling changes on its erectile dysfunction drug Viagra. Viagra labeling changes are in response to the reports that the drug caused a rare form of blindness called nonarteritic anterior ischemic optic neuropathy (NAION).
Pfizer released a statement saying the FDA concluded no casual relationship between Viagra and NAION has been established, but the company agreed to include the events in the Viagra labeling to help keep physicians and patients aware of the possible effects.
The company said it was concerned about a CBS News report that cited other reports of blindness among Viagra users because it could “unnecessarily alarm patients.” The CBS News report said other forms of blindness, in addition to the reports of NAION, have been made among Viagra users.
Pfizer first announced on May 27 that it would be working alongside the FDA to revise Viagra labeling despite believing the risk of NAION was not any greater among Viagra users than in men not taking the drug. In addition to the Viagra labeling changes, the U.S. House of Representatives just passed a measure banning Medicare and Medicaid reimbursement of erectile dysfunction drugs, calling them medically unnecessary. The bill will now move to the Senate.
For more information on Viagra and vision loss, please contact us to confer with an attorney.
