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, AMNews 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.

"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. [...]