The use of fluoroquinolone antibiotics has met with many controversies over the last few years as its side effects surfaced. The FDA in 2008 added a “Boxed Warning” on drug bottles which highlighted the potential adverse effects of the drug.
But now the FDA has enhanced the warnings on the packaging so as to help patients against serious side effects.
In May 2016 the FDA advised against the use of fluoroquinolone as first line of defense for conditions like sinus, bronchitis or urinary tract infections which can otherwise be treated with alternate medicines. In addition, FDA also asked the drug manufacturers to update safety precaution labeling on the bottle which was approved on Tuesday, 26th July.
These labeling changes include an updated ‘boxed warning’ and revisions to the precautions and potential side effects. The drug bottle will now contain a new limitation-to-use statements that will restrict the use of the drug to the patients who do not respond to other available drugs for their condition.
Fluoroquinolone is a wide-spectrum class of antibiotics due to which it is often over-prescribed for many medical conditions. Although this powerful medication is effective against a variety of bacterial strains, its side effects are found to outweigh its benefits. The drug, which can be taken orally or through injection, is associated with serious, irreversible side effects. These disabling side effects may take hours or weeks after first drug exposure to manifest and include tendinitis, tendon rupture, inflammation of the muscles, joints, nerve and damage to the central nervous system.
The FDA has also identified some serious conditions when the use of fluoroquinolone is recommended as first line of defense. These conditions include fatal anthrax infection, plague and bacterial pneumonia.