FDA proposes new labels for antibiotics

WASHINGTON (Reuters) -- The U.S. Food and Drug Administration Tuesday proposed warning labels on antibiotics to remind doctors that over-prescription and inappropriate use encourage the development of resistant bacteria.

"Antibiotic resistance is a serious and growing public health concern in the United States and the world," FDA Commissioner Jane Henney said in a statement.

FDA said many bacteria, such as those that cause pneumonia and other respiratory infections, have grown resistant to medication because doctors have over-prescribed it, giving the bacteria a greater chance to mutate.

"When we avoid the unnecessary use of antibiotics, we help preserve their effectiveness," Henney said.

The FDA said doctors need to learn to prescribe the antibiotics only when they are clinically necessary and to advise patients to use them properly.

The proposed label would say antibacterial drugs should only be used in situations where a bacterial infection was either proven or strongly suspected.

The label would specifically remind doctors that antibiotics do not treat viral infections.

Craig Hendrix, associate professor at Johns Hopkins University in Baltimore, Maryland, said there was a lot of pressure on doctors in United States to prescribe a drug to patients.

"When a patient comes to a doctor, they want something done and it is often easier to prescribe something which is an antibacterial drug to meet the needs of the patient when it may not help patients in general," said Hendrix. "This move on the part of the FDA sounds like a solid and necessary move."

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