August 29, 2004 in Nation/World

Health official asks FDA to reclassify Viagra

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A San Francisco public health official has petitioned the U.S. Food and Drug Administration to reclassify Viagra as a controlled substance, which would place the popular impotence pill in a category reserved for prescribed steroids and other legal drugs prone to abuse.

San Francisco’s director of Sexually Transmitted Disease Control, Dr. Jeffrey Klausner, is seeking the reclassification in light of studies showing an association between use of erectile dysfunction drugs and higher rates of unsafe sex and venereal disease.

He requested that Viagra and similar pills be listed as Schedule III controlled substances, an action that would make them more difficult to prescribe and easier to track because of more detailed reporting requirements.

Klausner’s petition also asks the FDA to require the Viagra label to include a warning that the popular impotence pill is linked to increased risk of sexually transmitted diseases, including syphilis and HIV/AIDS. He said similar warnings are warranted for Viagra competitors, the erectile dysfunction drugs Cialus and Levitra.

This is but the latest volley in the long-running campaign by Klausner to draw attention to the recreational use of Viagra. He has been talking to the FDA for two years about making a label change, and eventually decided to address the agency formally through a citizen’s petition, which was filed Aug. 4 and made public Monday. The FDA has 180 days to seek comment and rule on the request.

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