The FDA has strengthened previous warnings about the risk
for mental health side-effects and serious blood glucose disturbances
associated with fluoroquinolones.

The agency said it will require safety labeling changes for
the whole class of antibiotics and make the warnings more consistent across all
labels for both IV and oral doses.

It is the latest in a series of box warnings and safety
label updates that the FDA has issued for fluoroquinolones over the past
decade, including an enhanced warning in 2016 over the antibiotics’
association with tendon, muscle, joint, nerve and central nervous system

Because of these risks, the FDA recommends that
fluoroquinolones be reserved for patients with no other treatment options for
acute bacterial sinusitis, acute exacerbation of chronic bronchitis and
uncomplicated urinary tract infections, or for serious infections where
treatment benefits outweigh the risk for side effects.

The FDA said the new label changes were based on a
comprehensive review of the agency’s adverse event reports and published case

Mental health side effects were already a part of the
warnings and precautions section for fluoroquinolones but differed by
individual drug. Now, the FDA said it will require that mental health side
effects be listed separately from other central nervous system side effects and
be consistent across the labeling of the fluoroquinolone class. The mental
health side effects to be included in the labeling for all fluoroquinolones are
disturbances in attention, disorientation, agitation, nervousness, memory
impairment and delirium, the agency said.

In its review, the FDA said it found instances of hypoglycaemic
coma where patients using fluoroquinolones experienced hypoglycaemia. As a
result, the agency will now require that all fluoroquinolones include an
explicit warning of the potential risk for coma with hypoglycaemia in the blood
glucose disturbances subsection of the labeling.

“The use of fluoroquinolones has a place in the treatment of
serious bacterial infections — such as certain types of bacterial pneumonia —
where the benefits of these drugs outweigh the risks, and they should remain
available as a therapeutic option,” Edward Cox, MD, director of the
Office of Antimicrobial Products in the FDA’s Center for Drug Evaluation and
Research, said in a statement.