FDA Publishes Final Rule to Require Labeling About Antibiotic Resistance

WASHINGTON -- The Food and Drug Administration (FDA) announces that a final rule outlining new labeling regulations designed to help reduce the development of drug-resistant bacterial strains is on display at the Federal Register. This final rule is aimed at reducing the inappropriate prescription of antibiotics to children and adults for common ailments such as ear infections and chronic coughs.

Antibiotics are often prescribed to young children who have symptoms of ear pain or pressure sometimes accompanied by a slight fever even when the cause of the symptoms may be viral opposed to bacterial. The danger associated with prescribing antibiotics to children with viral infections is that it can hasten the development of bacterial strains that are resistant to that antibiotic. Moreover, these children may pass these antibiotic resistant bacteria on to others, making treatment of their illnesses even more complicated.

In older adults, the use of antibiotics to treat chronic coughs when sputum thickens is a common example of the over prescription of antibiotics. This thickening is commonly due to a viral infection, not a true bacterial infection such as bronchitis. Many of these patients would get better without antibiotic treatment.

The new rule applies to all systemically absorbed human antibacterial drugs and requires statements in several places in the physician labeling advising that these drugs should be used only to treat infections that are believed to be caused by bacteria. The rule also requires a statement in the labeling encouraging physicians to counsel their patients about the proper use of these drugs and the importance of taking them exactly as directed. This is part of ongoing efforts at FDA to encourage the development of new antimicrobials while preserving the usefulness of already existing ones.

"Antibacterial resistance is a serious and growing public health problem in the United States and worldwide," said FDA Commissioner Mark McClellan, MD, PhD. "Without effective antibiotic drugs, common infections, that were once easily treated, can create a serious health threat to children and adults alike."

Many bacterial species, including the species that cause pneumonia and other respiratory tract infections, meningitis, and sexually transmitted diseases, are becoming increasingly resistant to the antibacterial drugs used to treat them. Several bacterial species have developed strains that are resistant to every approved antibiotic.

Adoption of the rule represents the achievement of one of the objectives of the Public Health Action Plan To Combat Antimicrobial Resistance, a joint initiative of FDA, the Centers for Disease Control and Prevention (CDC), and the National Institutes of Health (NIH).

According to the CDC, half of the 100 million prescriptions a year written by office-based physicians in the United States are unnecessary because they are prescribed for the common cold and other viral infections, against which antibiotics are not active. Unnecessary use of antibiotics in hospitals is also reportedly common.

An electronic version of the final rule can be found at

http://www.fda.gov/OHRMS/DOCKETS/98fr/00n-1463-nfr00001.pdf. More information about antibiotic

resistance can also be found on FDA's Web site at www.fda.gov/oc/opacom/hottopics/anti_resist.html.