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US FDA warns Shionogi for misleading Cedax promotion

This article was originally published in Scrip

Executive Summary

Two professional direct mail promotions for ShionogiUSA's cephalosporin antibiotic Cedax (ceftibuten) are misleading because they minimise the product's risks and broaden its indications, the US FDAhas said in a warning letter. The mailers fail to reflect a bolded warning on hypersensitivity reactions and other labelled risks. They misleadingly imply that Cedax is effective for treating any middle ear or bronchial infection, when it is only approved for mild to moderate infections. The promotions also do not disclose that Cedax is approved for use only against susceptible strains of designated micro-organisms, therefore suggesting the antibiotic is effective against a wider range of pathogens than has been demonstrated. The FDA requests Shionogi to cease use of these and similar promotions and submit a corrective messaging plan.


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