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 Common Antibiotics Family Linked To Disabling Side Effects

The U.S. Food and Drug Administration (FDA) recently approved safety labeling changes fluoroquinolones, a class of antibiotics, to enhance warnings about their connection with disabling and potentially permanent side effects, such as permanent nerve damage. The labeling change also is designed to limit their use in patients who can benefit from other, safer drugs.
 
“Fluoroquinolones have risks and benefits that should be considered very carefully,” said Edward Cox, MD, director of the Office of Antimicrobial Products in FDA’s Center for Drug Evaluation and Research. “It’s important that both health care providers and patients are aware of both the risks and benefits of fluoroquinolones and make an informed decision about their use.”
 
Fluoroquinolones, including ciprofloxacin (Cipro), gemifloxacin (Factive), moxifloxacin (Avelox), norfloxacin (Noroxin), levofloxacin (Levaquin), and ofloxacin (Floxin), are used to treat illnesses such as respiratory and urinary tract infections.
 
While these medications have proven effective in treating serious bacterial infections, an FDA safety review found that both oral and injectable fluoroquinolones are associated with disabling side effects involving tendons, muscles, joints, nerves, and the central nervous system. These issues can occur hours to weeks after taking these drugs and may potentially be permanent.
 
The labeling changes include an updated Boxed Warning and revisions to the Warnings and Precautions section of the label about the risk of these adverse reactions and that they can occur together. The label also contains new limitation-of-use statements to reserve fluoroquinolones for patients who do not have other available treatment options for acute bacterial sinusitis, acute bacterial exacerbation of chronic bronchitis, and uncomplicated urinary tract infections.
 
The patient medication guide that is required to be given to the patient with each fluoroquinolone prescription describes the safety issues associated with these medicines.
 
This recent labeling revision also follows a May 12 drug safety communication from the agency advising that fluoroquinolones should be considered only when there are no other options available. The communication also announced the required labeling updates to reflect this new safety information.
 
This new warning will require practitioners to re-examine and change prescribing habits. Many prescribers in long term care have been quick to make fluoroquinolones a first choice for common infections such as uncomplicated UTIs, exacerbation of chronic bronchitis, and acute sinusitis,” said David Smith, MD, CMD, president of Geriatric Consultants in Brownwood, Texas.
“This new and more restrictive advice should be welcomed as information that will help us all comply with the medical principle, prima non nocere [first, do no harm]. I hope that old habits can be quickly abandoned. However, given the problems we've seen regarding antibiotic stewardship in general, I fear that needed change will be slow in coming.”
J. Kenneth Brubaker, MD, CMD, medical director of Masonic Village in Elizabethtown, Pa., added, “Unfortunately, since this family of antibiotics has been used inappropriately for many years, many are resistant to common bacteria found in urinary infections, pneumonias, and upper respiratory infections.” He added, “With the development of antibiotic stewardship programs in post-acute and long term care settings, we will be able to curtail the misuse of fluoroquinolones.”
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