Synercid is the first in a new class of antibiotics that will be used for seriously ill hospital patients who have not been helped by other antibiotics. It will also be used to treat certain types of skin infections that resist other treatments.
Because of the rise of drug-resistant forms of bacteria, the need for new antibiotics has become urgent. As a special case, the FDA allowed Synercid to be tested under an emergency program while it decided if the drug was safe and effective.
Over time, bacteria adapts to an antibiotic and can become resistant to a whole class of antibiotics. To stop resistance to antibiotics, it's important to use them only when necessary.
For example, many doctors prescribe antibiotics for the common cold - generally caused by viruses, not bacteria. Patients given an antibiotic by their doctors should finish the bottle as prescribed. If the treatment isn't completed, bacteria may not be totally "killed" and can come back again stronger than before.
While some doctors are calling Synercid their new last resort to the deadliest of bacteria, the drug is by no means a cure all. In studies of more than 2,000 patients, intravenous Synercid effectively quelled 52 percent of infections. More and better drugs are still needed to treat these increasingly resistant bacteria.
Synercid becomes the first backup in 30 years to that longtime "silver bullet," vancomycin.
Synercid, manufactured by Rhone-Poulenc Rorer, will be available for doctors to prescribe beginning Oct. 1. Rhone-Poulenc Rorer is based in Collegeville, Pa.
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.
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.
The FDA also approved Synercid to treat complicated skin infections caused by staph or strep bacteria, opening its use potentially to hundreds of thousands more patients.
Many of thse infections are still treatable with older antibiotics. But drug-resistant staph strains were thought to be confined to hospitals until the government last month discovered that four previously healthy children had died from antibiotic-resistant staph. So it is a growing problem.
Synercid's most frequently reported side effects were muscle and joint pain, nausea, diarrhea, vomiting and rash.
Synercid is a combination of two drugs -- quinupristin and dalfopristin -- that essentially deal bacteria a one-two punch, inhibiting two different methods of bacterial protein synthesis so the bugs cannot survive. It is the first in new class of antibiotics called streptogramins.