The FDA today proposed that all systemic antibacterial drug products
intended for human use contain additional labeling information about the
emergence of drug-resistant bacterial strains.
Over-prescribing and inappropriate use of antibiotics have
contributed to a dramatic increase in drug-resistant bacterial
infections. The proposal is intended to encourage physicians to prescribe
systemic antibiotics only when clinically necessary. It also encourages
physicians to counsel their patients on the importance of taking them
exactly as directed.
"Antibiotic resistance is a serious and growing public health
concern in the United States and the world," said Dr. Jane Henney,
Commissioner of Food and Drugs. "When we avoid the unnecessary use of
antibiotics, we help preserve their effectiveness."
Many bacteria, such as those that cause pneumonia and
other respiratory infections, meningitis, and sexually transmitted
diseases, are becoming increasingly resistant to antibiotics used to
treat them. Several bacterial species have developed strains that are
resistant to multiple anti-microbial drugs.
An important component of a comprehensive program to address the
problem of bacterial resistance is decreasing the unnecessary use of
antibacterial drugs. FDA is proposing to require that the labeling for
systemic antibacterial drug products include certain statements about the
inappropriate use of antimicrobials and the link between inappropriate
use and the emergence of drug-resistant bacterial strains.
Under the proposal the labeling would state that the following
reminders for physicians:
Antibacterial drugs should only be used in situations where a
bacterial infection is either proven or strongly suspected.
Anti-bacterials do not treat viral infections.
The type of bacteria involved in an illness and its
antimicrobial susceptibility pattern should be used to direct
the initial choice of an antibacterial.
Antimicrobial therapy should be modified once microbiologic
results are available.
Patients should be counseled about the proper use of antibacterials and
the importance of taking them only as directed.
A final rule based on this proposal would become effective one year
after the date of its publication in the Federal Register. After that
date, all systemic antibacterial new drugs and generic drugs (including
drugs that have already been approved and are currently on the market)
would have to comply with the labeling requirements.