Washington, DC: Today the Food and Drug Administration (FDA) advisory committee decided that for the treatment of sinusitis and bronchitis Ketek’s risks OUTWEIGHED the benefits and voted 17 to 2 against the continued marketing of Ketek. However, they also voted 16 to 3 to support the continued marketing of Ketek for pneumonia provided that the labeling included a black box warning, the strongest warning that the FDA can give. Rep. Edward J. Markey (D-MA), a senior member of the Energy and Commerce Committee, has been investigating the FDA’s approval of Ketek since May 2006 and released the following statement:

“Today the advisory committee sent a strong message to the FDA that Ketek’s risks can no longer be ignored.  The FDA should listen to their advisory committee and act swiftly to protect the public from the serious risks of this antibiotic.  Congress now needs to conduct an investigation to determine how Ketek was allowed onto the market in the first place despite fraud and unresolved safety questions and why the FDA has dragged its feet in responding to the serious risk posed by this drug.”

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