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JAMA. 1999;282:1613.

	Since this article does not have an abstract, we have provided the first 150 words of the full text and any section headings.

The FDA has approved Synercid (Rhone-Poulenc Rorer, Collegeville, Pa), the first antimicrobial drug to treat infections associated with vancomycin-resistant Enterococcus faecium (VREF) bacteremia. Synercid, a combination of quinupristin and dalfopristin, also received approval for the treatment of complicated skin and skin structure (SST) infections (such as cellulitis/erysipelas, postoperative infections, and traumatic wound infections) caused by methicillin-susceptible Staphylococcus aureus and Streptococcus pyogenes.

The VREF indication received accelerated approval under FDA's regulations that allow early marketing of products for use in life-threatening conditions when other therapies are not available. The approval was based on Synercid's ability to clear VREF from the bloodstream, with clearance of bacteremia considered to be a surrogate end point.

Of the 1222 patients enrolled in four noncomparative studies for the treatment of VREF, 24.4% could not be evaluated because of the severity of illness, the emergency-use nature of the trials, and the variability in data collection. A . . . [Full Text of this Article]

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