FDA News

FDA strengthens safety warnings for fluoroquinolones

Ed Cox
Edward Cox

The FDA is strengthening warnings about the risk for mental health side effects and serious blood sugar 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 disabilities.

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 reports.

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 hypoglycemic coma where patients using fluoroquinolones experienced hypoglycemia. As a result, the agency will now require that all fluoroquinolones include an explicit warning of the potential risk for coma with hypoglycemia 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.

“The FDA remains committed to keeping the risk information about these products current and comprehensive to ensure that health care providers and patients consider the risks and benefits of fluoroquinolones and make an informed decision about their use,” he said.

Disclosure: Cox works for the FDA.

Ed Cox
Edward Cox

The FDA is strengthening warnings about the risk for mental health side effects and serious blood sugar 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 disabilities.

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 reports.

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 hypoglycemic coma where patients using fluoroquinolones experienced hypoglycemia. As a result, the agency will now require that all fluoroquinolones include an explicit warning of the potential risk for coma with hypoglycemia 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.

“The FDA remains committed to keeping the risk information about these products current and comprehensive to ensure that health care providers and patients consider the risks and benefits of fluoroquinolones and make an informed decision about their use,” he said.

Disclosure: Cox works for the FDA.