MedImmune Pulls FluMist Pamphlet

The move comes after the FDA says it didn't contain enough information about side effects.
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MedImmune

(MEDI)

has withdrawn a promotional pamphlet for its nasal spray flu vaccine FluMist after the Food and Drug Administration said the document didn't contain enough information about side effects.

A spokeswoman for MedImmune said Tuesday the company removed the pamphlet on June 21 after receiving a warning letter from the FDA. The pamphlet had been placed in the offices of physicians, primarily pediatricians.

The FDA said the promotional flyer was misleading because it failed to include "sufficient information on risks and adequate directions of use." The agency said the flyer failed to include side effects that are listed on the drug's label.

Potential side effects include cough, headache, irritability and muscle aches. The label notes that FluMist shouldn't be given to pregnant women; to people with conditions such as asthma; to children and adolescents taking aspirin; to people with suspected immune deficiencies; or to people who are hypersensitive to the vaccine's components, including eggs or egg products.