Shionogi misleads public over antibiotic-US FDA

Promotional material for Shionogi & Co Ltd’s antibiotic Cedax (ceftibuten) misleads the public by downplaying the drug’s risks and making exaggerated claims, the U.S. Food and Drug Administration said in a warning letter to the company released on Tuesday.

Cedax is approved to treat mild to moderate infections, including acute chronic bronchitis and severe ear infections. Side effects include possible severe allergic reactions, colon infections, and diarrhea, among other complications.

But direct mailers and handouts for doctors did not mention many of Cedax’s risks and claimed the drug had “excellent tolerability,” creating “the misleading impression that Cedax is safer” than data show, Thomas Abrams, head of the FDA’s marketing division, said in a letter to the company.

They also imply that the drug can treat a wider range of infections than those the FDA approved, such as any ear or bronchial infections, he said.

“These violations are concerning from a public health perspective because they suggest that the product is both safer and effective in a broader range of conditions than has been demonstrated by substantial evidence or substantial clinical experience,” Abrams wrote.

The FDA requested a response from Sinology’s U.S. unit by December 1. If the company does not cease its promotions, the agency could impose fines or other civil penalties, although most such cases are resolved without punitive action.

Shionogi USA Inc. President and Chief Executive Officer Sapan Shah did not immediately return a call seeking comment.

The letter, dated Nov. 14, was released on the FDA’s website at http://www.fda.gov/foi/warning_letters/s7024c.htm.

By Susan Heavey