The labeling is intended to encourage physicians to prescribe antibiotics only when clinically necessary and to counsel their patients about the proper use of these drugs and the importance of taking them as directed. There is growing evidence that the overuse of antibiotics has led to greater bacterial resistance, making it more difficult to treat many common illnesses.
The Centers for Disease Control estimates that half of the 100 million antibiotic prescriptions written by office-based doctors each year are unnecessary. FDA believes professional labeling is important in educating both doctors and patients.
Labels for all systemic drug products used to treat bacterial infection, except a mycobacterial infection, must include the following:
• At the beginning of the label, under the product name, it must state that to reduce the development of drug-resistant bacteria and to maintain the effectiveness of the antibacterial drug product and other antibacterial drugs, the drug should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria.
• In the “Intentions and Usage” section, the label must state the same thing except it should identify the bacteria as susceptible. It must also state that when culture and susceptibility information are available, they should be considered in selecting or modifying antimicrobial therapy. Absent such data, local epidemiology and susceptibility patterns may contribute to the selection of the therapy.
• In the “General” subsection of the “Pre-
cautions” section, the label must state that prescribing the antibacterial product of a proven or strongly suspected bacterial infection for a prophylactic indication is unlikely to benefit the patient and increases the risk of the development of drug-resistant bacteria.
• In the “Information for Patients” subsection of the “Precautions” section, the label must state that patients should be counseled that antibacterial drugs should only be used to treat bacterial infections and that they do not treat viral infections, such as the common cold.
Patients should also be told that although it is common to feel better early in the therapy, the medication should be taken exactly as directed. The label must tell physicians to counsel patients that skipping doses or not completing the full course of the therapy may decrease the effectiveness of the immediate treatment and increase the likelihood that bacteria will develop a resistance and will not be treatable by antibacterial drugs in the future.
The rule becomes effective February 6, 2004.