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Republic Sen. Charles Grassley, R-Iowa, and chairman of the Senate Finance Committee, says he is “troubled” by how long it is taking the FDA to change Viagra labeling to include a possible link to vision loss that has been reported to the agency in 38 Viagra users.
Grassley says an FDA safety evaluator recommended Viagra labeling changes on March 1, 2004, but the label has yet to be revised. When questioned about the lapse in time between the recommendation and now, the safety official said the agency was under pressure to approve new drugs. In a June 24 letter that Grassley sent to the FDA’s acting director Dr. Lester Crawford that appeared in The Washington Post, the letter said, “often safety concerns needed to ‘fit in’ wherever it could.” Both the FDA and Viagra’s maker, Pfizer Inc., has said there is no direct evidence that the drug is responsible for the vision loss, but Grassley questioned whether the cases of blindness are underreported.
The FDA said in May that it had 43 reports of vision loss, including 38 among Viagra users, four among Cialis users and one for Levitra – both Viagra competitors. Varying levels of vision loss was reported, including blindness. Given Viagra was used by 23 million men worldwide since its 1998 approval, Pfizer says the reports of vision loss are small. Still, Grassley’s letter questions if the number of adverse events are underreported since ophthalmologists are not the normal Viagra prescribers, requiring patients to offer the information that they are taking Viagra to the eye doctors.
Grassley asked Crawford to provide all FDA documents regarding Viagra and blindness risks, including internal notes, memos, e-mails and correspondence. In addition, he also asked for copies of correspondence between Pfizer and the federal agency. The letter had a July 15 deadline for FDA response.
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