FDA committee voted limited approval for new antibiotic
Friday, April 27th 2001, 12:00 am
By: News On 6
WASHINGTON (AP) _ A Food and Drug Advisory Committee gave qualified approval for one use of a new antibiotic on Thursday, but turned thumbs down on other proposed uses.
The panel voted 7-3 to recommend approval of the drug Ketek, also known as telithromycin, for community-acquired pneumonia. That's a common form of pneumonia affecting as many as 4 million Americans annually.
But committee members called for additional safety studies of the drug and urged that it be closely monitored for side effects when used, said Dr. Dianne Murphy of the FDA.
The advisory committee voted unanimously against recommending the drug for cases of acute chronic bronchitis and 8-2 against its use for sinusitis.
A proposal that the drug be allowed in infections of penicillin-resistant or erythromycin-resistant strep was turned down 7-3.
The FDA isn't bound to accept the recommendations of its advisory committees, but usually does so.
Murphy said the panel urged additional, large, safety trials with Ketek to ``see if hints of concern ... are real or not'' about effects on the heart and liver.
She said the group was worried about ``silent toxicity'' if the drug interacted with other products, potentially causing an increase in liver enzymes and also possibly a prolongation of the heartbeat.
Dr. Frank Douglas, Aventis head of drug innovation and approval, said the company will work with the FDA to address the committee's safety concerns.
Also to be worked out is the labeling for the drug if FDA goes along with the recommendation for approval in cases of CAP.
While the panel recommended approval for one use but rejected others, once a drug is on the market doctors can prescribe it for non-recommended uses. That worried the committee, Murphy said, noting that in the past some drugs have had to be withdrawn because they were being used for non-recommended uses.
We have to get it right the first time,'' she said, ``before doctors start a prescribing pattern.''
Ketek is intended as an alternative to drugs that have lost their effectiveness in pneumonia and other diseases.
For years, drugs called macrolides _ such as erythromycin _ have been the usual treatment. But germs like strep and staph are growing resistant to them.
Ketek is one of a new type of antibiotic called ketolides. They are derived from the macrolides, but are chemically different and can kill bacteria that are resistant to the older drugs.