FDA approves long-needed

                  new antibiotic

                  September 21, 1999
                  Web posted at: 2:42 p.m. EDT (1842 GMT)

                  WASHINGTON (AP) -- The government approved a long-needed new weapon against the growing threat of drug-resistant bacteria:
                  Synercid, the first alternative in 30 years to the antibiotic of last resort. 

                  The new drug comes at a critical time, as doctors are warning that more and more germs are developing resistance to that "silver bullet" antibiotic, vancomycin. 

                  Indeed, the need was so great that the Food and Drug Administration for the past year has allowed hundreds of patients at risk of death from drug-resistant germs to be treated with Synercid under a special emergency program, while the agency decided whether the drug was safe and effective enough for broad sale. 

                  The FDA announced Tuesday that Synercid was approved to treat vancomycin-resistant enterococcal infections, a life-threatening infection that strikes thousands of hospital patients. 

                  One recent study estimated as many as 52 percent of enterococcal infections are now vancomycin-resistant, making them difficult if not impossible to treat.

                  But doctors must do the proper laboratory testing before prescribing Synercid to make sure patients' infections are caused by the most deadly type of enterococcus -- called E. faecium, the FDA stressed. Synercid works well against E. faecium, but is not very effective against a related and more common enterococcal infection that other antibiotics still can cure, the FDA said. 

                  The FDA also approved Synercid to treat certain complicated skin infections caused by Staphylococcus aureus bacteria, commonly known as staph infections, or by the germ Streptococcus pyogenes. 

                  But it is not a miracle drug. Synercid doesn't work as well as existing
                  antibiotics for some infections, scientists have stressed -- and because
                  bacteria evolve rapidly, Synercid resistance eventually will appear, too. 

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

                  Synercid was studied in more than 2,000 patients, and its overall
                  effectiveness at fighting off infection was 52 percent, the FDA said. 

                  The most frequently reported side effects were muscle and joint pain, nausea,
                  diarrhea, vomiting and rash. 

                  Synercid, an intravenous antibiotic, will be available for doctors to prescribe
                  beginning October 1. 

                  Synercid, manufactured by Rhone-Poulenc Rorer, is the first in a new class
                  of antibiotics called streptogamins to be sold in the United States, and it
                  appears to work by dealing bacteria a one-two punch. 

                  It is a combination of two drugs -- quinupristin and dalfopristin -- that inhibit
                  two different methods of bacterial protein synthesis. That combination effect
                  makes the chemicals 16 times more potent together than either molecule
                  alone, the company says.