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FDA Advisory Panel Suggests "Black Box" Warning For Ketek and More Restricted Use

Sanofi-Aventis Antibiotic Ketek: Serious Side Effects Outweigh Benefits For Bronchitis and Sinusitis

An FDA advisory panel, which included drug-safety experts and infectious-disease specialists, recommended in December 2006 that the Sanofi-Aventis antibiotic Ketek should remain on the market in the U.S. but under several conditions.

First, this panel of outside experts recommended that a so-called "black box" warning be added to the Ketek package insert, or label, in order to bring more attention to the reports of drug-induced hepatitis, liver damage, and liver failure which have been associated with Ketek use.

Second, the panel members recommended to the FDA that the drug company Sanofi-Aventis prepare a medication guide for patients who are prescribed Ketek in the future.

Third, the advisory panel concluded that Ketek should no longer be used as a treatment for acute bacterial exacerbation of chronic bronchitis nor acute bacterial sinusitis, which uses are currently approved by the FDA. The panel voted in favor of the continued prescribing of Ketek for a more serious medical condition, community-acquired pneumonia, .

It is important understand that the FDA is not required to follow this panel's guidance as regards the future prescribing and use of Ketek, i.e., recommendations made by an FDA advisory panel are "nonbinding".

As reported in a December 15, 2006 Associated Press article about Ketek: "Doctors have prescribed the antibiotic more than 5.6 million times in the United States since the FDA approved it in 2004."

While this FDA advisory panel did not recommend a Ketek recall, according to a December 13, 2006 report about Ketek by CBS News, "there is a new Congressional probe under way to determine whether Ketek should remain on the market." (Note: There is an extended interview with a patient who suffered liver failure after taking Ketek for bronchitis available at the online version of this December 13 CBS report about Ketek.)

Read more on our Ketek Information Page >>

  • US FDA advises that you should not stop taking any prescription medication before talking to your doctor.
  • Reports of serious drug side effects should be made to the US FDA MedWatch program.
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