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Originally published July 21 2005

FDA halts MedImmune flu nasal spray brochure citing lack of important details

by Mike Adams, the Health Ranger, NaturalNews Editor

The Food and Drug Administration claims MedImunne's brochure for their nasal spray influenza treatment, FluMist, lacks important directions for use as well as potential side effects, and has demanded the Gaithersburg-based company to recall the brochure.



The Food and Drug Administration has slapped MedImmune with an order to stop using a consumer-directed sales brochure for its FluMist nasal-spray influenza vaccine. In a letter dated June 21 and posted today on the FDA's Web site (www.fda.gov/foi/warning_letters/g5372d.htm), Gaithersburg-based MedImmune was told the document lacks directions for use and details on certain risks. The government said the brochure also did not inform consumers that FluMist shouldn't be taken by people who hypersensitive to eggs or egg products or have a weak immune system, nor by children or adolescents being treated with aspirin. FluMist, which contains a live flu virus, can only be given to healthy people ages 5 to 49. The company is performing tests in an effort to get age restrictions lifted. MedImmune (Nasdaq: MEDI - News) says it stopped using the brochure immediately after receiving the FDA letter and is in talks about it with regulators.


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