FDA calls for extra labeling for antibacterial drugs

Among other things, the agency wants antibiotic labels to remind doctors to advise patients on proper use.

By Kathleen F. Phalen, amednews correspondent. Jan. 15, 2001.

Because of a rise in drug-resistant bacterial infections, the Food and Drug Administration recently proposed that drug manufacturers place more warning labels on antibiotics.

Intended to encourage more judicious prescribing patterns, the proposal reflects a growing concern about the overprescription and inappropriate use of antibiotics, according to the FDA.

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"Antibiotic resistance is a serious and growing public health concern in the United States and the world," said FDA Commissioner Jane Henney, MD. "When we avoid the unnecessary use of antibiotics, we help preserve their effectiveness."

Drug-resistant bacteria have been around for the past 50 years, since antibiotics became widely available. But in recent years the prevalence has dramatically increased, making many illnesses -- respiratory tract infections, sexually transmitted diseases, meningitis and pneumonia -- more difficult to treat. According to the FDA, several bacterial species have developed strains that are resistant to every approved drug.

In some parts of the country, more than 40% of Streptococcus pneumoniae are highly resistant to penicillin. And approximately 70% of bacterial infections acquired in health care settings are resistant to at least one antimicrobial drug, according to the Centers for Disease Control and Prevention.

Several factors contribute to this increased prevalence, but studies point to substantial antibiotic overuse. Office-based physicians in the United States write more than 100 million prescriptions for antibiotics each year. The CDC says that 50 million are inappropriate.

"There is tremendous patient demand. Everyone wants the wonder drug, the magic bullet," said Stephen H. Zinner, MD, Charles Davidson professor of medicine at Harvard Medical School and chair of the Dept. of Medicine at Mount Auburn Hospital in Cambridge, Mass. "And doctors no longer have time to explain that [patients] don't need this drug. It's sometimes easier to give it. So anything that is done to break this cycle is a step in the right direction."

Under the FDA proposal, manufacturers would be required to state that inappropriate use may increase the prevalence of drug-resistant microorganisms and may decrease the effectiveness of the drug product. Labeling also would include the following reminders for physicians:

Antibacterials should be used only in situations where a bacterial infection is proven or strongly suspected, not with viral infections.
The type of bacteria involved in an illness and its antimicrobial susceptibility pattern should direct the initial drug choice.
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.

Nonetheless, Dr. Zinner expressed some concerns. Labeling would heighten awareness. But it also could add costs that slow the development of new antibiotics.

"Does this put pharmaceutical companies on notice that more studies on resistance are needed?" Dr. Zinner asked. "It would be nice if we could stem the tide of increasing resistance problems. But it doesn't necessarily follow that labeling will have an effect on slowing [drug-resistant bacteria]. ... The argument needs to be examined from both sides."

The FDA is evaluating information received during the comment period to determine if the proposed rule requires revision prior to its September effective date.