FDA subjects antibiotic to new scrutiny in wake of reports of death and injury

Tuesday, November 14th 2006, 10:19 am

By: News On 6

WASHINGTON (AP) _ A novel antibiotic linked to rare reports of severe liver problems, including several deaths, will be subjected to new scrutiny by federal health advisers, according to a document released Tuesday.

The Food and Drug Administration has asked a joint panel of outside experts to discuss the overall risks and benefits of the antibiotic Ketek during a Dec. 14-15 meeting, according to a federal notice.

The announcement comes as the Senate Finance Committee investigates allegations of fraud connected with trials of Ketek, as well as how the FDA has handled safety issues associated with the drug.

The joint panel's two-day review of Ketek could lead to a recommendation that the agency add further warnings to the label of the Sanofi-Aventis SA drug, or take other action.

Ketek, also called telithromycin, already carries a bold-type warning about the rare reports of liver failure and severe injury, some of them fatal, in patients treated with the drug.

The FDA approved Ketek in 2004. The drug is used to treat respiratory tract infections, bronchitis, sinusitis and community-acquired pneumonia.

Through April, the FDA received at least a dozen reports of acute liver failure, including four deaths, among people treated with Ketek. The FDA also knows of at least 23 other cases where patients suffered serious liver injuries after receiving the antibiotic.

The FDA, in previously disclosed documents, has said the rate appeared higher in comparison with similar antibiotics, although publicity surrounding a study that appeared in January could have stimulated the reporting of further problems. That can skew perceptions of the risk of Ketek compared with older but similar antibiotics.

Sanofi-Aventis welcomes the opportunity to discuss Ketek, company spokeswoman Lisa Kennedy said. ``Based on the data available to us, and in consultation with leading experts, we continue to believe the benefits of Ketek outweigh its risk when the drug is used as directed for its approved indications,'' Kennedy said.

An FDA spokeswoman did not immediately return a call seeking comment.