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news.Sanofi-Aventis has said that a regulatory panel advising the FDA has rejected its drug Ketek as a treatment for acute exacerbation of chronic bronchitis and acute bacterial sinusitis.
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The FDA has recommended the drug’s continued use for community acquired pneumonia, although only as a secondary treatment. The FDA committee concluded that the risks outweigh the benefits for lesser diseases.
Recent reports have linked Ketek to liver failure, vision problems, aggravation of myasthenia gravis and other side effects. The committee was convened by the FDA for a two-day hearing to review the overall benefit-risk profile of Ketek.
“Sanofi-Aventis will be in further discussion with the FDA regarding today’s recommendations,” said Doug Greene, chief medical officer at Sanofi-Aventis US.
According to Sanofi-Aventis, Ketek has been used to treat more than six million patients in the US and more than 28 million patients worldwide.