FDA Approves Aventis’ Ketek, First in New Class of Antibiotics
FDA on Thursday approved Ketek, an Aventis drug that is the first in a new class of antibiotics called ketolides, offering an alternative for doctors in fighting drug-resistant strains of pneumonia, the AP/Houston Chronicle reports. Ketek is also approved to treat sinusitis and bronchitis. About 20 percent of streptococcus pneumoniae are currently multidrug-resistant, according to Paul Iannini, a Yale University professor of medicine who researched Ketek. The new drug may prove less likely to spur drug resistant strains, Iannini said, because it targets more bacteria in the respiratory tract, rather than throughout the body. He added that Ketek also has chemical properties that appear less likely to "push a germ into true resistance," the AP/Chronicle reports. Ketolides block the development of proteins by bacteria and are effective against several drug-resistant strains that cause bronchitis and pneumonia. Ketek, which is a pill taken daily for usually five days, would reach the U.S. market just as other general-purpose antibiotics are becoming ineffective against a wide range of bacteria (AP/Houston Chronicle, 4/1). Ketek underwent four years of FDA scrutiny before winning approval, after having been approved in Europe in 2001, major Latin American countries in 2002 and Japan in October 2003, the Wall Street Journal reports (Wall Street Journal, 4/2). FDA had raised questions about Ketek's possible liver and heart effects after the drug won approval in Europe, but the agency has since eased its concerns. According to the AP/Minneapolis Star Tribune, FDA indicated that Ketek could increase the risk of muscular damage for patients taking cholesterol-lowering drugs, and Ketek users occasionally experienced temporary vision blurring. Ketek will be available by prescription in late July, an Aventis spokesperson said (AP/Minneapolis Star Tribune, 4/2).This is part of the California Healthline Daily Edition, a summary of health policy coverage from major news organizations. Sign up for an email subscription.