The side effects can involve damage to tendons, muscles, joints, nerves and the central nervous system.
Based on the findings, the FDA will require that drug labels and medication guides for all fluoroquinolone antibiotics include the new safety information.
The FDA announcement focused on fluoroquinolone antibacterial drugs, including the common, powerful antibiotic ciprofloxacin, which is used to treat people with uncomplicated urinary tract or sinus infections or bronchitis.
Examples of fluoroquinolones include Avelox, Cipro, and Levaquin.
The FDA was asked to review warning labels for fluoroquinolones past year after patients and doctors nationwide expressed concerns about the devastating see effects.
Those having these conditions should reserve fluoroquinolones for cases in which there are no alternative treatment options, says the FDA.
Fluoroquinolones are very commonly prescribed.
“The agency continuously reviews the available sources of data to make a determination about the safety and efficacy of fluoroquinolones and will keep health care providers and the public informed of new information”. “As an infectious disease doctor though, with any antibiotic, we should always think twice before we prescribe it”.
The FDA added that it will continue to investigate the antibiotics’ safety issues.
See the FDA Drug Safety Communication for a list of now available FDA approved fluoroquinolones for systemic use. Bayer said it is aware of the FDA statement and will work closely with the FDA on the topic.
Johnson & Johnson said it is studying the FDA’s statement and noted that Levaquin has been used for more than 20 years.
Fluoroquinolones are broad-spectrum antibiotics, effective for both gram-negative and gram-positive bacteria, that play an important role in treatment of serious bacterial infections, especially hospital-acquired infections and others in which resistance to older antibacterial classes is suspected.