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US FDA warns Shionogi over antibiotic promotion

Tue Nov 25, 2008 10:05am EST

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WASHINGTON, Nov 25 (Reuters) - U.S. health regulators have warned Shionogi & Co Ltd's (4507.T) U.S. unit over misleading promotion of its antibiotic Cedax that omits the drug's risks and makes exaggerated claims, according to a letter released on Tuesday.

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"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," Thomas Abrams, head of the FDA's marketing division wrote in a letter to the company.

The letter, dated Nov. 14, was released on the FDA's website here. (Reporting by Susan Heavey, editing by Gerald E. McCormick)

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