First in new class of antibiotics approved
FDA gives go-ahead to Ketek to fight pneumonia
The Associated Press
Updated: 8:02 p.m. ET April 01, 2004
WASHINGTON - Doctors are about to get the first in a new class of antibiotics to treat patients with a type of drug-resistant pneumonia, as well as those with sinusitis and bronchitis.
The Food and Drug Administration approved Ketek late Thursday. It’s the first ketolide, a new family of antibiotics structurally similar to drugs like that old standby erythromycin — but different enough to offer an alternative that could prove important for certain patients, said FDA anti-infectives chief Dr. Janice Soreth. Doctors are “eager to have another option,” she said.
Dr. Paul Iannini, a Yale University professor of medicine who helped research the drug, predicted it will quickly become a first-line choice.
A type of strep bacteria that causes community-acquired pneumonia is increasingly able to overpower one or more antibiotics. About 20 percent of streptococccus pneumoniae now is multi-drug-resistant, Iannini said. Newer antibiotics called fluoroquinolones have been used to treat drug-resistant strep pneumonia, but a few strains resistant to those drugs are starting to form.
Ketek not only would offer an important option for patients running out of other options, but it may prove less likely to spur germs to resist antibiotics, Iannini said.
First, it more specifically targets bacteria in the respiratory tract than germs throughout the body; many other antibiotics are more broad-ranging.
Second, it has chemical properties that seem less likely than certain other drugs, such as erythromycin, to push a vulnerable germ into true resistance, Iannini said.
Drug-resistant pneumonia aside, Ketek is approved to treat acute bacterial sinusitis and acute flare-ups of chronic bronchitis, conditions that affect thousands of Americans. Patients would use the drug for five to 10 days, depending on the condition being treated.
In studies that compared Ketek with certain other antibiotics, the drug proved equally effective and had similar side effects, Iannini said.
While Ketek has been sold in other countries since 2001, its U.S. approval was hard-won. The FDA first raised questions about possible liver and heart side effects that same year. Closer examination eased those concerns.
Usual side effects were similar to other antibiotics, such as nausea and headache, said maker Aventis Pharmaceuticals.
But FDA did have some special warnings:
Ketek could increase the risk of muscle damage in patients taking three common cholesterol-lowering drugs called statins — Zocor, Mevacor and Lipitor. Users of those statins should temporarily quit the anti-cholesterol pills until they’re through using Ketek, Soreth said.
Very rarely, Ketek users experienced some vision blurring. It seemed to happen more often to women under 40, and does seem to go away once the drug is stopped, Soreth said. People experiencing the side effect should avoid driving or other hazardous activities.
Aventis said Ketek will be available, by prescription, in late July; it wouldn’t disclose a price.
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