Appropriate Use of Antibiotics Highlighted in New FDA Rule

The Food and Drug Administration has mandated changes in labeling for antibiotics, according to a final rule issued today (Fed. Reg., pps. 6062-6081). The rule reflects “a growing concern in FDA” that unnecessary use of systemic antibacterials “has contributed to a dramatic increase in prevalence of drug- resistant bacterial infections.” According to the Centers for Disease Control and Prevention, half of the 100 million antibiotic prescriptions written by office- based U.S. physicians are unnecessary. The new rule also encourages physician counseling of their patients about appropriate use of antibiotics.