Ketek Side Effects and FDA Under Investigation by Congress

A congressional subcommittee voted Tuesday to subpoena former and current Food and Drug Administration investigators to testify about fraudulent clinical data that supported approval of the antibiotic drug Ketek.

Ketek was approved in 2004. It is manufactured by Sanofi Aventis SA. Last February, after getting reports of liver failure in some patients treated with the drug, the FDA issued a black box warning _ its sternest _ and restricted use to patients with pneumonia.

The four people subpoenaed had conducted their own probe in connection with Ketek's approval. For months, lawmakers 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.

If you have experienced severe bronchitis or other bacteria-related respiratory illnesses, you know how you long for a quick end to your misery.

Ketek, manufactured in the U.S. by Aventis Pharmaceuticals, is an orally-taken medication, typically prescribed to adults who have lung and/or sinus infections that have been caused by bacteria rather than a virus.

In early 2006, the U.S. Food and Drug Administration (FDA) was alerted of a much more serious adverse reaction to Ketek. Three cases of liver damage as a result of using the medication alerted the FDA and caused a media hubbub. Of these three cases, one ended in the patient's death, the other in the patient receiving a liver transplant, and the third resulted in drug-induced hepatitis.

Other Side Effects of Ketek

All these cases have led many to question whether Ketek is actually a
defective drug. For instance, was it rushed to market because Aventis wanted to
win a share of the market that erythromycin controlled at that time?