New safety labels added to entire class of fluoroquinolones
Oral and injectable fluoroquinolones are associated with side effects involving tendons, muscles, joints, nerves, and the central nervous system, an FDA safety review found. These side effects may occur hours to weeks after use and can be permanent.
Fluoroquinolones will have to carry stronger warnings about the risk of disabling and potentially permanent side effects, and their use should be limited in patients with less serious bacterial infections, the FDA announced on July 26.
Both oral and injectable fluoroquinolones are associated with side effects involving tendons, muscles, joints, nerves, and the central nervous system, an FDA safety review found. These side effects may occur hours to weeks after use and can be permanent. The labeling changes include an updated boxed warning and revisions to the warnings and precautions section of the label, which also contains new limitation-of-use statements, according to an FDA press release.
For patients with acute bacterial sinusitis, acute exacerbation of chronic bronchitis, and uncomplicated urinary tract infections, the risks of these side effects generally outweigh the benefits, according to the FDA, which recommends reserving fluoroquinolones for patients with these conditions who have no other treatment options. However, the benefits of the drug class outweigh the risks for some serious bacterial infections, such as anthrax, plague, and bacterial pneumonia.
The FDA in 2008 added the first boxed warning to fluoroquinolones, which cautioned of increased risk of tendinitis and tendon rupture. In 2011, the risk of worsening symptoms for patients with myasthenia gravis was added to the boxed warning. A 2013 label update warned of the potential for irreversible peripheral neuropathy. In May, the agency issued a drug safety communication advising that fluoroquinolones should be used for acute bacterial sinusitis, acute exacerbation of chronic bronchitis, and uncomplicated urinary tract infections only when there are no other options available.
FDA-approved fluoroquinolones include levofloxacin (Levaquin), ciprofloxacin (Cipro), ciprofloxacin extended-release tablets, moxifloxacin (Avelox), ofloxacin, and gemifloxacin (Factive).