FDA approves long-needed new antibiotic

WASHINGTON -- It's a doctor's nightmare: The 60-year-old is recovering fine from a heart bypass when suddenly his surgical wound becomes inflamed and a fever spikes.

He has picked up an infection -- maybe germs from a previous patient lingered on his bedrail, or a health care worker checked his bandages with dirty hands. Worse, his drug-resistant infection is not responding to the antibiotic of last resort, vancomycin.Doctors who until now would have had to watch such a patient die won a new weapon Tuesday against the growing threat of drug-resistant bacteria: An antibiotic called Synercid becomes the first backup in 30 years to that longtime "silver bullet," vancomycin.

"For those of us who treat the most sick patients, in hospitals where they do a lot of major surgery ... having another option is very important," said Dr. George Eliopoulos of Beth Israel Deaconness Hospital in Boston.

But Synercid is not an all-purpose magic bullet. The Food and Drug Administration approved its use only in certain infections -- albeit ones that strike hundreds of thousands of patients -- because it works well against some germs but not others.

And doctors should not use Synercid when other antibiotics will do, because overuse will simply hasten bacteria's inevitable development of resistance against this new drug, the FDA warned.

"The drug should be used judiciously," stressed FDA antibiotics chief Dr. Sandra Kweder. "For many patients it will be a drug of last resort, and we'd like to protect it for as long as possible."

Some infectious disease experts predicted Synercid's cost -- at $85 per intravenous vial, over four times more expensive than vancomycin -- will persuade doctors to save it for the sickest patients. It will be available on Oct. 1.

In studies of more than 2,000 patients, intravenous Synercid effectively quelled 52 percent of infections.

Synercid is most important in fighting a fearsome germ spread to thousands of hospitalized patients called "vancomycin-resistant Enterococcus faecium." It can live for days on doorknobs, bedrails, even stethoscopes, and is infamous for causing lethal infections in the abdomen, urinary tract, post-surgical wounds and heart valves.

In one study of 330 patients infected with that supergerm, 90 percent had their infection clear up within 72 hours of starting treatment with Synercid, the FDA said.

But hospitals must do special tests to be sure patients have an E. faecium infection, because Synercid does not work against another, more common but less deadly, type of enterococcal infection, the FDA stressed.