FDA To Require New Labels on Antibiotics To Warn Against Overuse
The FDA yesterday announced a final rule that will require new labels on antibiotics to warn physicians to prescribe the treatments only for bacterial infections to help prevent overuse, a practice that can lead to the growth of antibiotic-resistant bacteria, AP/USA Today reports. According to the FDA, physicians often prescribe antibiotics for children and adults with viral infections, although antibiotics have no effect on viruses (AP/USA Today, 2/6). The FDA estimates that half of the 100 million prescriptions that physicians write for antibiotics each year are unnecessary because they are used to treat viral infections (Dow Jones/Wall Street Journal, 2/6). The FDA also will require the labels to warn physicians to inform patients to take antibiotics as directed, not to share the treatments with others and to continue to take the medications for the full course of treatment (AP/USA Today, 2/6). Bacteria have become more resistant to antibiotics as a result of overuse, and as a result, "old standbys" such as penicillin no longer treat many common bacterial infections, the AP/USA Today reports (AP/USA Today, 2/6). "Antibacterial resistance is a serious and growing public health problem in the United States and worldwide," FDA Commissioner Mark McClellan said, adding, "Without effective antibiotic drugs, common infections, that were once easily treated, can create a serious health threat to children and adults alike" (FDA release, 2/5). The new rule, which the FDA proposed in 2001, will require the new labels on antibiotics by Feb. 6, 2004 (AP/USA Today, 2/6).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.