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New drug OK'd to combat antibiotic-resistant organisms
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10-4-99 Rockville, Md. In hopes of stemming the growing threat of antibiotic-resistant organisms, the Food and Drug Administration approved Synercid Sept. 21 for the treatment of infections that fail to respond to vancomycin, the "last-resort" antibiotic of the past 30 years. Synercid (a combination of quinupristin and dalfopristin) was expedited through the approval process to treat vancomycin-resistant Enterococcus faecium and complicated skin and skin structure infections. According to the FDA, Synercid has been found safe and effective for treatment of skin and soft tissue infections caused by methicillin-susceptible Staphylcoccus aureas and Stretptocuccus pyogenes. It is estimated that there are as many as 20,000 cases of vancomycin-resistant infections annually, up from one case in 1989. Resistant patients include those who are undergoing chemotherapy, transplant recipients, and those who have otherwise compromised immune systems. These infections can also be a problem for postsurgical patients, the elderly, and children. Though Synercid was granted accelerated approval, FDA officials say that early approval does not shortcut the process. "A priority review is of the same quality and looks at the same material as would be done for a traditional new drug application," said Alexander Rakowsky, MD, of the Center for Drug Evaluation and Research at the FDA, in a written statement. Experts caution that lab tests must be done to make sure the infecting bacteria is E. faceium because Synercid is not effective against a related and more common enterococcal infection. FDA officials hope judicious use of the drug will help maintain its effectiveness. "We can suggest that overuse of this drug for either its other approved use (skin and soft tissue) or for off-label uses may shorten its effectiveness lifespan due to augmentation of resistance development," Rakowsky said. Synercid, an IV antibiotic, will be available Oct. 1. The manufacturer is Rhone-Poulenc Rorer, a French company with U.S. headquarters in Pennsylvania.
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