Flonase ads failed to disclose risk

The Food and Drug Administration claims that Glaxo Wellcome's Spanish-language television advertisements for Flonase® (fluticasone) nasal spray, which ran in Puerto Rico in 1998 and 1999, failed to disclose risk information.

In an August 18 warning letter to the company, the FDA said the ads failed "to provide information relating to the major side effects and contraindications" and failed to make "adequate provision for the dissemination of the approved labeling, or inclusion of the brief summary of information related to the side effects and contraindication in conjunction with the advertisement."

The FDA letter continued: "In fact, the advertisement mentions only the indication for Flonase (relief of nasal allergy symptoms) and provides no risk information at all."

In addition, Glaxo Wellcome failed to submit the ads to the FDA, which requires such submissions at the time of the advertisement's first use.

Glaxo Wellcome has discontinued the ads, but the FDA is requiring that the company "assure FDA that similar advertisements are not being disseminated anywhere in the United States or its territories and possessions." PR