FDA Updates Safety Warnings for Fluoroquinolone Antibiotics

Roni Shye
Roni Shye, PharmD BCGP BCACP, is a licensed pharmacist in the states of Florida, Ohio, and Pennsylvania.
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On May 10th, 2017, the FDA issued a safety update on fluoroquinolone antibiotics, like Cipro and Levaquin, as part of an ongoing review.

About a year ago, the FDA released findings that fluoroquinolone antibiotics can cause dangerous side effects involving the tendons, muscles, joints, nerves and central nervous system, and advised that use should be restricted in uncomplicated situations.

However, the FDA has reviewed all reports and updated their safety warning. Although some negative side effects are still possible, the FDA does not believe that fluoroquinolone antibiotics can result in detachment of the retina, or tears in the aorta blood vessel.

At this time, the FDA has determined that fluoroquinolone antibiotics should be avoided, if possible, in the following infections: acute bacterial sinusitis, acute bacterial exacerbation of chronic bronchitis, and uncomplicated urinary tract infections. Your doctor may prescribe a fluoroquinolone antibiotic for one of these infections if there are no other treatment options available for you. Be sure to speak with your doctor about the possible side effects.

What are fluoroquinolone antibiotics?
Fluoroquinolone antibiotics include Cipro (ciprofloxacin), Levaquin (levofloxacin), Avelox (moxifloxacin), Factive (gemifloxacin), and ofloxacin. These drugs are typically used to treat urinary tract infections, sinus infections, respiratory infections, typhoid, and pneumonia.

What side effects are related to fluoroquinolone antibiotics?

If you have been prescribed a fluoroquinolone antibiotic be sure to seek medical attention if you experience any side effects like unusual joint or tendon pain, muscle weakness, tingling or pricking sensation, numbness in arms or legs, confusion or hallucinations.

What has been done to warn people about these serious side effects? 

Drug manufacturers of all fluoroquinolone antibiotics are required to update their boxed warning and patient medication guides to reflect the side effects. The FDA will continue to assess the safety issues with fluoroquinolone antibiotics.

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