FDA tells Glaxo to pull misleading Flonase ads

U.S. regulators ordered GlaxoSmithKline Plc to pull radio and print advertisements for its Flonase prescription nasal allergy spray that the Food and Drug Administration deemed misleading. The FDA said the advertisements suggesting that Flonase can be substituted for the prescription allergy medicines Allegra, Clarinex or Zyrtec are in violation since the GlaxoSmithKline drug is not approved for as many allergy symptoms as the other three. Allegra, Clarinex and Zyrtec are oral antihistamines approved for a wide range of symptoms, including itchy, watery eyes. Flonase, a corticosteroid, is approved only for the nasal symptoms associated with seasonal allergies.

In a letter to Europe’s biggest drugmaker, the FDA said Flonase is neither therapeutically equivalent to the oral antihistamines nor interchangeable with or a substitute for them. It said the ads “misleadingly suggest that because Flonase is comparable or superior to the other allergy medicines, the consumer need consider only the possible insurance co-payment cost in considering switching to Flonase.” The FDA said Flonase has not been demonstrated to be safe and effective in treating any of the non-nasal symptoms. “GSK should immediately discontinue the radio and print ads and all other promotional materials and activities for Flonase that contain the same or similar violative presentations,” the letter, posted on the FDA’s Web site, said. The agency said GlaxoSmithKline should submit a written response to the FDA’s Division of Drug Marketing, Advertising, and Communications on or before July 3, describing its intent and plans to comply. GlaxoSmithKline did not immediately return calls seeking comment. (c) 2003 Reuters Limited

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