Resistance to antibacterials is a serious and growing health concern, said FDA Commissioner Dr. Jane Henney, attributing this growing resistance, in part, to overuse. The warning would remind physicians to prescribe the antibacterials only where a bacterial infection is either proven or strongly suspected. The type of bacteria should dictate which drug to use, and the use of the antibacterials should be modified when test results are available. The label would also remind doctors to counsel patients about the importance of taking the drug only as directed.
A final rule would take effect one year after publication, and all systemic antibacterial new drugs and generic drugs, including those already approved and on the market, would have to comply.