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FDA Says Cedax Claims Misleading

Dec 1, 2008 | Parker Waichman LLP

Federal health officials have charged  the maker of Cedax with making misleading claims about the antibiotic.   According to Reuters, the Food & Drug Administration (FDA) has issued a warning letter to Shionogi & Co. Ltd for exaggerating the effectiveness of Cedax and downplaying its side effects.

Cedax, known generically as ceftibuten, is a 3rd generation cephalosporin antibiotic.  According to Reuters, Cedax is approved to treat mild to moderate infections, including acute chronic bronchitis and severe ear infections.  It is also associated with a variety of side effects, including severe allergic reactions, colon infections, and diarrhea.

According to the FDA warning letter faxed to Shionogi on November 14, direct mailers promoting Cedax " present numerous efficacy claims for Cedax but fail to reveal material risk information associated with use of the drug".   The FDA said the only risk disclosure presented for Cedax  in the mailers is the following statement : "Low incidence of diarrhea (only 4% in children) ." The FDA said the Cedax mailers failed to present any of the other risks associated with Cedax, including serious hypersensitivity reactions.

The FDA also criticized the mailers because the information on diarrhea is framed as a positive claim ("Low incidence . . ."), is presented under a bullet titled "Excellent tolerability", and is listed along with another positive claim about the drug.  The FDA said that as a result, the mailers present Cedax as being safer than has been demonstrated by substantial evidence or substantial clinical experience.

The letter also says that the mailers are misleading because they suggest that Cedax is effective in a broader range of conditions than has been demonstrated by substantial evidence or substantial clinical experience.  

Shionogi has until today to reply to the allegations included in the Cedax warning letter, Reuters said.  If the company does not cease the Cedax promotions cited in the warning letter, the FDA could impose fines or other civil penalties.


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