FDA Updates Fluoroquinolone Labels to Emphasize Ri
Post# of 72440
Posted On: 07/27/2016 10:28:19 AM
FDA Updates Fluoroquinolone Labels to Emphasize Risks for Disabling Adverse Events
July 27, 2016
By Amy Orciari Herman
Edited by David G. Fairchild, MD, MPH, and Lorenzo Di Francesco, MD, FACP, FHM
The FDA has updated the labels of systemic fluoroquinolones (e.g., ciprofloxacin, levofloxacin) to note that they're associated with numerous serious and potentially irreversible adverse effects that can occur simultaneously. For patients with sinusitis, bronchitis, or uncomplicated urinary tract infections, the agency says, these antibacterials should be used only when there are no alternative options.
Disabling side effects may include tendinitis, tendon rupture, muscle pain, muscle weakness, joint pain, joint swelling, peripheral neuropathy, and central nervous system effects (e.g., depression, psychosis). Adverse reactions may begin within hours or weeks of treatment initiation; data suggest that such reactions last, on average, 14 months after stopping treatment.
Both the boxed warning and "warnings and precautions" section of the drug labels have been updated.
Healthcare providers should stop fluoroquinolone treatment at the first indication of a serious adverse reaction, the FDA says. In addition, they should avoid using fluoroquinolones in patients who've had adverse reactions in the past.
Link(s):
FDA MedWatch safety alert (Free)
Background: Physician's First Watch coverage of FDA's May 2016 call for more restrictions on fluoroquinolones (Free)
July 27, 2016
By Amy Orciari Herman
Edited by David G. Fairchild, MD, MPH, and Lorenzo Di Francesco, MD, FACP, FHM
The FDA has updated the labels of systemic fluoroquinolones (e.g., ciprofloxacin, levofloxacin) to note that they're associated with numerous serious and potentially irreversible adverse effects that can occur simultaneously. For patients with sinusitis, bronchitis, or uncomplicated urinary tract infections, the agency says, these antibacterials should be used only when there are no alternative options.
Disabling side effects may include tendinitis, tendon rupture, muscle pain, muscle weakness, joint pain, joint swelling, peripheral neuropathy, and central nervous system effects (e.g., depression, psychosis). Adverse reactions may begin within hours or weeks of treatment initiation; data suggest that such reactions last, on average, 14 months after stopping treatment.
Both the boxed warning and "warnings and precautions" section of the drug labels have been updated.
Healthcare providers should stop fluoroquinolone treatment at the first indication of a serious adverse reaction, the FDA says. In addition, they should avoid using fluoroquinolones in patients who've had adverse reactions in the past.
Link(s):
FDA MedWatch safety alert (Free)
Background: Physician's First Watch coverage of FDA's May 2016 call for more restrictions on fluoroquinolones (Free)
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