FDA Considering Restricting Off-Label Use of Antibiotics

This is good news:

The overuse of antibiotics “has reached crisis proportions,” said Dr. Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research, who also attended the meeting. One solution the agency is exploring is a new category of approved drugs with limited uses that would attempt to curtail the use of new antibiotics — capable of fending off infections that don’t respond to multiple drugs — by approving them only for very narrow indications.

Doctors would understand from the special designation that a particular antibiotic shouldn’t be given for, say, garden-variety pneumonia or strep throat but only to those suspected of having a drug-resistant infection.

It will be interesting to see what the FDA does with tigecycline. Right now, tigecycline is used off-label to treat carbapenem-resistant infections–bacteria that are resistant to every penicillin derivative and also are usually resistant to most other antibiotics. Hopefully, they won’t throw the baby out with the bath water.

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