- The Food and Drug Administration on Tuesday approved a broader warning label for the entire class of fluoroquinolone antibiotics, following up on a safety alert published in May that cautioned against using the drugs in certain patients.
- Fluoroquinolones should now be reserved for use only in patients who have no alternative treatments for acute bacterial sinusitis, acute exacerbation of chronic bronchitis and uncomplicated urinary tract infections, the FDA said.
- In those patients, the risks of "disabling and potentially permanent" side effects outweigh the benefits of use. Fluoroquinolones have previously been linked to increased risk of tendon rupture and serious nerve damage.
Fluoroquinlones are a class of strong antibiotics and include Johnson & Johnson's Levaquin, Bayer's Cipro, Merck's Avelox and LG Life Sciences' Factive. All four are available in generic forms.
In 2008, the FDA required the drugs to carry a boxed warning cautioning of the risk of tendinitis and tendon rupture. That warning was expanded in February 2011 to include the risk of worsening symptoms for those with myasthenia gravis, and again in August 2013 for the risk of serious and potentially irreversible nerve damage.
An advisory panel determined last November the risk of these side effects occurring together and leaving lasting damage was too high to use fluoroquinolones for uncomplicated infections.
The FDA agreed and has now updated the warning labels to reflect the potential for multiple side effects occurring together and adding a limitation-of-use statement.
However, in the case of certain serious bacterial infections, such as anthrax, plague and bacterial pneumonia "the benefits of fluoroquinolones outweigh the risks and it is appropriate for them to remain available as a therapeutic option."