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WASHINGTON, Feb 6. 2003 — Antibiotics will soon need to carry warnings advising doctors to avoid unnecessary prescriptions, which have become a major contributor to the problem of drug-resistant infections.
The new requirement, announced by the Food and Drug Administration, aims to reduce inappropriate prescribing of antibiotics for common ailments such as ear infections and chronic coughs, which often are caused by viruses that do not respond to antibiotics.
Antibiotics only kill bacteria, but patients often request them for treating a variety of infections.
Starting next year, antibiotic labels will be required to include instructions for doctors to prescribe them only when an infection is proven or strongly suspected to be caused by bacteria.
The labels also will encourage physicians to counsel patients about what types of infections require antibiotic treatment, as well as remind them to take all of their medication, even if they feel better in a few days.
Not completing a full course of treatment can give microbes the chance to mutate to resist antibiotics, causing infections that are harder to treat.
According to the Center for Disease Control and Prevention, 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.
"Antibiotic resistance is a serious and growing public health problem, not only in this country but worldwide," FDA Commissioner Mark McClellan said, noting that the growth of resistant germs is outpacing development of new antibiotics. "We may end up in a situation where we don’t have effective antibiotic drugs for common infections that were once easily treated."
The agency plans to try and publicize the warnings through medical journals and professional medical societies.
Reacting to the announcement, Jeff Trewhitt, a spokesman for the Pharmaceutical Research and Manufacturers of America, said the drug industry group had just begun reviewing the new rule, but declined further comment.
