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FDA issues Viagra labeling change

–July 8, 2005

Thirteen months after learning about reports of sudden blindness in men taking well-known erectile dysfunction drug Viagra, as well as Cialis and Levitra, the FDA has finally ordered updated labeling for the drugs. The federal agency was criticized for sitting on the reports for so long before warning healthcare professionals and consumers of the events.

Most of the blindness reports were made among patients taking Viagra. In May, Viagra maker Pfizer Inc. said it had received reports of 23 cases in which men taking the drug had either gone blind or lost a portion of their vision. The FDA said it had information of about 38 cases in which men taking Viagra had suffered vision impairment, but the agency said the cases were associated to a reduced blood flow to the eye in patients who were also suffering from diabetes and high blood pressure.

The FDA has advised patients to discontinue taking Viagra and other erectile dysfunction drugs if they experience sudden or decreased vision loss in one or both eyes. Sen. Charles E. Grassley (R-Iowa) wrote a letter to the acting FDA chief prior to the recent announcement charging an FDA safety officer had noted the Viagra risks from monitoring adverse event reports and told her supervisors that physicians and the public should be warned, yet the agency had not taken sufficient actions. In the letter, Grassley wrote that he was "troubled by the FDA's action, or lack thereof, relating to the updating of Viagra's product label."

For more information on Viagra, please contact us to confer with an attorney.

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