Feds approve new silver bullet’
FDA also seeks new classification
A new antibiotic, Synercid, has become the newest weapon in a very limited arsenal in the fight against the growing threat of drug-resistant bacteria. With recent approval by the Food and Drug Administration (FDA), Synercid became the first drug in 30 years that can offer backup to the so-called "silver bullet," vancomycin.
The drug combines quinupristin and dalfopristin and basically hits bacteria with a one-two punch by inhibiting two different methods of bacterial protein synthesis so the bacteria cannot survive. It is the first in a new class of antibiotics called streptogramins.
Because the drug works well against some bacteria but not against others, the FDA has approved the drug’s use only for certain infections. Researchers caution that physicians should not prescribe Synercid when other antibiotics will work, because overuse will simply hasten bacteria’s inevitable development of resistance to the new drug.
"The drug should be used judiciously," says FDA antibiotics chief Sandra Kweder, MD. "For many patients it will be a drug of last resort, and we’d like to protect it for as long as possible."
Synercid’s cost of $85 per intravenous vial — more than four times costlier than vancomycin — should also encourage doctors to prescribe it for only their sickest patients. The most frequently reported side effects of Synercid are muscle and joint pain, nausea, diarrhea, vomiting, and rash.
Studies show that intravenous Synercid effectively quelled 52% of infections in more than 2,000 patients. It is most important in fighting vancomycin-resistant enterococcus faecium, which can live for days on doorknobs, beds, and even stethoscopes. It is infamous for causing lethal infections in the abdomen, urinary tract, post-surgical wounds, and heart valves. Ninety percent of 330 patients infected with vancomycin-resistant bacteria had their infection clear up within 72 hours of starting treatment with Synercid.
More approvals
The FDA also approved the new drug for treatment of complicated skin infections caused by staphylococcus or streptococcus bacteria, opening Synercid’s potential use to hundreds of thousands more patients. Drug-resistant staphylococcus strains, formerly believed to be confined to hospitals, were recently found to have caused the deaths of four previously healthy children who had not been hospitalized.
The FDA says that continuing problems with catheter infections are the motivation for its proposal to reclassify catheter and infusion therapy equipment into Class II (special controls). Class II equipment consists of subcutaneous, implanted, intravascular (IV) infusion ports and catheters, and percutaneous, implanted, long-term catheters for repeated vascular access. Public comments on the proposal are due by Dec. 30.
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