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USDA tells FluMist to stop using misleading flier


WASHINGTON - MedImmune Inc. must stop using a marketing brochure for FluMist, its nasal-spray influenza vaccine, because the document lacks directions for use and details on potential risks, federal regulators said.

"This consumer-directed flier is misleading because it fails to reveal material facts regarding the risks associated with the use of FluMist," the Food and Drug Administration said in a warning letter dated June 21 and posted yesterday on the agency's Web site. "More specific information is necessary."

FluMist generated $54 million in sales in 2004 but has been a major disappointment in the marketplace, given that it is the only approved alternative to traditional flu vaccine, which was in short supply for much of last year's flu season.

FluMist contains a live flu virus and can be given only to healthy people ages 5 to 49. It isn't approved for young children and the elderly, two groups that have a high risk of flu complications such as pneumonia.

MedImmune, which is based in Gaithersburg, Md., stopped using the brochure immediately after receiving the letter last week and is in talks with the agency, said Clarencia Stephen, a company spokeswoman.

The FDA said the flier didn't list side effects and was vague about potential risks that are specified in the vaccine's label. MedImmune's brochure also didn't inform consumers that people shouldn't use FluMist if they are hypersensitive to eggs or egg products, have a history of Guillain-Barre Syndrome or a weak immune system, or are children or adolescents being treated with aspirin, the FDA letter said.

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