FDA Panel Hits Antibiotic For Bronchitis, Sinusitis

FRIDAY, Dec. 15 (HealthDay News) -- A U.S. Food and Drug Administration advisory committee recommended late Friday that a "black-box" warning be added to the controversial antibiotic Ketek for its use in fighting pneumonia.

It's also possible that the drug will lose its approval for two lesser indications, sinusitis and bronchitis.

The FDA panel voted 17-to-2 that Ketek's benefits for patients with those milder conditions do not outweigh risks associated with the drug, which include liver damage and other events.

"For community-acquired pneumonia, we got a general sense from the committee that the majority of members felt there should be a black-box warning added to the labeling to address some of the risks associated with the drug," said Dr. John Jenkins, director of the office of new drugs at the FDA's Center for Drug Evaluation and Research. "We also got the sense -- and the company is in agreement -- that there should be a medication guide required to be handed out with each prescription."

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Jenkins spoke at a news conference Friday night, capping two days of meetings during which an outside panel of experts heard testimony about Ketek's safety and efficacy.

At the end of the second day, the committees voted 16-to-3 that the benefits of Ketek (telithromycin) outweighed the risks for community-acquired pneumonia, a potentially life-threatening condition.

Asked whether the FDA would rescind the drug's indications for bronchitis and sinusitis, Jenkins responded, "We will be assessing the advice we heard from the committee and will be discussing that internally. We can't announce what the regulatory action will be, but we will take the committee's advice very seriously."

Finally, committee members voted 13-to-5 in favor of a black-box warning for the pneumonia indication (one committee member had left by the time that vote was taken).

"This is a decision that places safety first," said Dr. Klaus-Dieter Lessnau, a board-certified lung and critical-care medicine specialist at Lenox Hill Hospital in New York City. "Similar things have been said about other medications including Tylenol, which is over-the-counter. This doesn't mean Ketek shouldn't be used. It's a balance of risks and benefits. The main thing is that patients who get yellow eyes or pain in the belly should see a doctor."