FRIDAY, Dec. 15, 2006 (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."
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."
Ketek is used to treat certain types of bronchitis, sinusitis and pneumonia. But since its approval in 2004, hundreds of cases of liver damage, loss of consciousness and other side effects have been reported. According to the Wall Street Journal, U.S. doctors wrote more than 3.35 million prescriptions for the antibiotic in 2005, bringing in $193 million in revenues.
The drug and the related approval process have been haunted by criticism, however.
In June, the drug's maker, Sanofi-Aventis, agreed to update Ketek's labeling to reflect the possibility of severe liver damage.
Last month, a European Medicines Agency panel recommended that Ketek not be given to patients with a history of such liver conditions as hepatitis or jaundice.
And during the first day of hearings Thursday, the FDA was forced to defend its use of post-marketing data from Europe to approve the drug.
The U.S. Senate Finance Committee is also investigating allegations of fraud involving clinical trials of Ketek and is looking into how the FDA handled Ketek-related safety issues, Bloomberg News reported.
Sen. Charles Grassley, an Iowa Republican, accused the FDA of withholding relevant information at the time of the drug's approval and has asked FDA Commissioner Dr. Andrew von Eschenback to respond by Jan. 17 to allegations that the agency had knowingly used fraudulent safety data to approve Ketek.
Committee members themselves spoke of an arduous session that involved 13 pounds of reading material mailed to them before the briefing even began.
"It was a particularly challenging meeting for the two committees within the context of continued critical concerns for diminished interest in the development of anti-infective agents pharmaceutical agents in general and an increased concern for safety considerations for drugs in general," said Dr. John Edwards, acting chair of the Anti-Infective Drugs Advisory Committee.
"Antibiotics and all drugs have a certain amount of risk associated with them, and those of us who use drugs and prescribe drugs have a great concern for the possibility that the risks may occur in any given individual patient," Edwards added. "So, yes, we are cautious about the use of the drugs both specifically and in general. And much of the discussion today was around caution in using anti-infectives."
More information
For more on the briefings, visit the FDA.
