A congressional subcommittee wants to subpoena criminal investigators at the Food and Drug Administration about their own probe concerning the antibiotic Ketek, which has been linked to liver failure.

For months, subcommittee leaders have alleged that the FDA approved Ketek even though the agency knew the large safety study it required before approval was fraught with data problems. A vote on issuing the subpoenas is scheduled for Tuesday.

Ketek was approved in 2004 to treat respiratory tract infections, bronchitis, sinusitis and community-acquired pneumonia. After receiving reports of liver failure in patients treated with the drugs, the FDA last February issued a black box warning — its sternest — and restricted use to patients with pneumonia.

Ketek, metabolized by the liver, is an orally-taken medication. Typically, it is prescribed in adult (over 18) patients who have lung and/or sinus infections that have been caused by bacteria rather than a virus. mlive

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Defective Drugs