Labeling Changes for Antibacterials


FDA has published a final rule to change the labeling of systemic antibacterial drug products. The agency hopes to encourage physicians to prescribe them only when clinically necessary.
According to FDA, overprescription of such drugs has contributed to a recent increase in drug-resistant bacterial infections. It estimates that half of the 100 million such prescriptions written in the United States each year are unnecessary. 

The rule, published in the February 6, 2003, Federal Register [68 FR:6062--6081], will go into effect on February 6, 2004.

It calls for the beginning of the label to state that the product should be used to treat or prevent only infections caused or strongly believed to be caused by bacteria. 

In the "Indications and Usage" section, that message must be repeated. 

It must state that culture and susceptibility information, when available, should be used in selecting or modifying antimicrobial therapy. In the absence of such data, local epidemiology and susceptibility patterns should be considered.

The "Precautions" section must note that prescribing the product if there is no proven or strongly suspected bacterial cause is unlikely to benefit the patient. In fact, it could risk the development of drug-resistant bacteria.

The "Information for Patients" section must advise patients that antibacterial drug products should be used to treat only bacterial infections, not viral infections. They should be told to take the medication exactly as directed. 
FDA estimates the annualized costs of compliance to the rule to be less than $600,000. 

For further information, contact Christine F. Rogers, Center for Drug Evaluation and Research (HFD-7), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857; 301/594-2041.

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