Fluoroquinolone Induced Tendinopathy

In 2008, the FDA first released a Black Box Warning for tendon rupture associated with the fluoroquinolone use. Currently marketed fluoroquinolones in the United States are: ciprofloxacin (Cipro), moxifloxacin (Avelox), levofloxacin (Levaquin), ofloxacin (generic only), and gemifloxacin (Factive).
Tendon rupture occurs in 0.14-0.44% of patients prescribed fluoroquinolones, and most commonly occurs in the achilles tendon, although it can occur in virtually any tendon. Tendon rupture is often diagnosed via ultrasound and MRI. The average time of onset is approximately 2 weeks from initial dose of fluoroquinolone. Patients will typically present with the following signs/symptoms in any of their tendons: pain and swelling, hearing or feeling a snap or pop, bruising right after injury and inability to move affected area or bear weight. It’s important to inform patients to not exercise and seek medical help right away if these signs or symptoms occur. The most common risk factors for tendon rupture, are patients with renal dysfunction, advanced age, concomitant corticosteroid use, and history of solid organ transplant. Others include: Diabetes Mellitus, prior musculoskeletal injury, sporting activity and gout. When using fluoroquinolones for uncomplicated bacterial infections (i.e. UTI, COP exacerbations, sinusitis), the FDA has determined that there are serious risks outweighing the benefits. For more serious bacterial infections (i.e.anthrax, plague, bacterial pneumonia) the benefits outweigh the risks and should remain a possible option for those patients considered low risk.

References:
1. US Dept of Health and Human Services. FDA Drug Safety Communication. FDA updates warnings for oral and injectable fluoroquinolone antibiotics due to disabling side effects. Food and Drug Administration. Updated Sept 2016. Accessed Mar 1 2017. Available at: http://www.fda.gov/Drugs/DrugSafety/ucm511530.htm

2. Lang, T, Cook, J, et al. What tendon pathology is seen on imaging in people who have taken fluoroquinolones? A systematic review. Fundam clin Pharmacol. 2017, Feb; 31 (1): 4-16. Doi: 10.1111/fcp.12228.

3. Bidell, M, Lodise, T. Fluoroquinolone- associated tendinopathy: does levofloxacin pose the greatest risk? Pharmacology. 2016. 36 (6) 679-93. Doi: 10.1002/phar.1761. Epub 2016 Jun 11.

4. Levaquin. [package insert]. Titusville, NJ. Janssen Pharmaceuticals, Inc. 2017.