The biologics division at the FDA issued a warning letter to MedImmune’s vaccines unit claiming that the leaflet promoting the company’s nasal spray was misleading. The company removed the document from circulation on June 21. Prior to this the flyer had been available in the offices of physicians and primarily pediatricians across the US.
According to the FDA the flyer failed to include the side effects listed on the drug’s label thus misleading patients as to the associated risks involved with using FluMist. The agency said more detailed information was needed.
Possible side effects linked to the use of FluMist include headaches, coughs, irritability and muscle aches. The label also notes that pregnant women, children taking aspirin and people with immune deficiencies or asthma should not be given the vaccine. In addition, people with hypersensitivity to the drugs ingredients, including eggs, should be warned against its use.
The drug has been a disappointment to the marketplace even though it generated $54 million in sales during 2004. Higher revenues were expected because it is the only approved alternative to the traditional flu vaccine which lacked abundance for much of last year.