In August, 2016, the U.S. Food and Drug Administration (FDA) added a black box warning to the packaging of antibiotics known as fluoroquinolones for serious side effects that include potentially permanent damage to muscles, joints, tendons, nerves and the central nervous system.
Approximately 80% of all fluoroquinolone prescriptions are for Cipro, which has been tied to an increased risk for potentially deadly skin rashes, including Stevens Johnson Syndrome (SJS) and Toxic Epidermal Necrolysis (TEN).
The first symptoms of SJS are very similar to the flu; however, after the flu symptoms stop, a skin rash consisting of red or purple blisters on the skins and in the mucous membranes of the body. The SJS rash kills the skin cells, causing large areas of skin to slough off.
If the rash covers less the 30% of the body, SJS is diagnosed. However, if the rash covers more than 30% of the body, the diagnosis will be Toxic Epidermal Necrolysis (TEN), which has a mortality rate of 30-40% versus a mortality rate of 5-10% for SJS.
Fluoroquinolones are the most popular antibiotics in the U.S. and are used in the treatment of bacterial infections. FDA-approved fluoroquinolones include Levaquin (levofloxacin), Cipro (ciprofloxacin), ciprofloxacin extended-release tablets, Avelox (moxifloxacin), ofloxacin and Factive (gemifloxacin).
The FDA issued warnings about fluoroquinolone side effects in 2008 and 2011, and in 2015, the FDA’s advisory committee ruled that the risks of fluoroquinolones outweigh the benefits when used for uncomplicated bacterial infections.
Two 2015 studies linked fluoroquinolones to aortic damage that could lead to aneurysms and tears in the wall of the aorta. A Journal of the American Medical Association (JAMA) study associated the use of fluoroquinolones with a two-fold increase in the risk of aneurysm and aortic tears within 60 days of using the drug. In addition, a BMJ study found a three-fold increase in the risk of aneurysm from the use of fluoroquinolones.
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