Though multiple other antibiotics have been ineffective, a new antibacterial drug may prove victorious against a hardy infection that occurs most often in hospitalized patients and those with weakened immune systems.
Synercid (a combination of quinupristin and dalfopristin) was approved to treat infections associated with the Enterococcus faecium bacterium when there is no other effective treatment and an infection has even resisted treatment with the drug vancomycin, previously viewed as the last-resort medication.
Since 1989, when the first case of vancomycin-resistant Enterococcus faecium was reported, the U.S. incidence of this potentially life-threatening condition has increased rapidly.
Because Synercid is for such a serious condition, the drug was granted early approval based on its ability to clear the bloodstream of infection. A study is under way to verify the drug's beneficial effect at the specific site of infection.
In clinical trials of more than 2,000 patients, the overall effectiveness rate among those who could be fully evaluated was 52 percent. The drug's most common side effects were muscle and joint pain, nausea, diarrhea, vomiting, rash, and, when the drug was injected through a peripheral vein, reactions around the injection site such as pain and inflammation.
FDA's approval of Synercid in September 1999 made it the first drug in its "streptogramin" class to be approved in the United States for human use. The approval followed the recommendations of the Anti-Infective Drugs Advisory Committee.
Also approved to treat complicated skin and soft tissue infections, Synercid is marketed by Rhone-Poulenc Rorer, a French company with U.S. headquarters in Collegeville, Pa.
COPYRIGHT 2000 U.S. Government Printing Office
COPYRIGHT 2004 Gale Group
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