FDA approves first ketolide antibiotic

The drug offers a welcome alternative in fighting bacterial infections, but experts warn it still must be used appropriately to prevent development of resistant strains.

By Victoria Stagg Elliott, AMNews staff. April 26, 2004.

The Food and Drug Administration's April approval of telithromycin, the first of a new class of antibiotics known as ketolides, has physicians excited about another choice to treat bacterial infections but also concerned that it could worsen the problem of overuse that leads to bacterial resistance.

"It's always helpful to have a range of choices," said Elizabeth Steiner, MD, assistant professor of family medicine at Oregon Health and Science University in Portland. "But we have to be very careful about not overusing it so that we prevent potential resistance problems and not put ourselves in a position of being overly dependent on an antibiotic."

The drug will provide another possibility on the list of effective antibiotic pills for easy outpatient use. This list is under continual threat by emerging bacterial resistance as well as the lack of new options in the pharmaceutical research and development pipeline.

"Bacteria are able to survive because they are able to evolve, and that's why it's so important to have a pipeline of new antibiotics," said Paul Iannini, MD, one of the drug's researchers and a clinical professor of medicine at Yale University School of Medicine. "It really gives us physicians a new choice."

Still, some experts maintained that having one more drug is not a solution to antibiotic resistance.

"It's great that we have new antibiotics coming out to combat bacteria that are resistant to older antibiotics, but the same problems apply," said Jeffrey Linder, MD, MPH, an internist at Brigham and Women's Hospital and Harvard Medical School in Boston. "It needs to be prescribed for only appropriate indications, and if we misuse it, the potential is there for resistance."