SUPER-ANTIBIOTIC: FDA Approves Weapon Against Resistance
The FDA yesterday approved Synercid, a much-anticipated weapon in medicine's escalating war against drug-resistant bacteria. Manufactured by Rhone-Poulenc Rorer Inc., Synercid has been approved for use against Enterococcus faecium, a type of bacteria that commonly infects seriously ill patients with weakened immune systems, such as transplant recipients and cancer patients. The drug also is approved for treating complicated skin infections caused by staph and strep bacteria. E. faecium infects roughly 16,000 hospitalized patients annually and has become difficult to treat, as the bacteria has grown increasingly resistant to vancomycin, the "silver bullet" antibiotic that physicians have used for 30 years as a last resort (Stolberg, New York Times, 9/22). To address the crisis of vancomycin-resistant infections, the FDA granted hundreds of at-risk patients access to Synercid through a "special emergency program" while it reviewed the proposal to make the drug widely available (AP/Boston Herald, 9/21). Recent studies of more than 2,000 severely ill patients show the drug to be 52% effective in warding off E. faecium infections.
Keeping It Effective
To ensure Synercid remains an effective defense against the resistant strains, experts are advocating judicious use of the intravenous drug, which costs roughly $85 per dose. Observers hope its cost will encourage discretion among physicians (Neergaard, AP/Detroit Free Press, 9/22). George Eliopoulos, an antibiotics researcher at Beth Israel Deaconess Medical Center, said he expects some bacterial resistance to the new drug will "emerge and it's just our hope that it will emerge slowly and to a minimal degree." Synercid is projected to capture up to 5% of the market for vancomycin, which is currently used on roughly 1.4 million Americans each year (Okie, Washington Post, 9/22).