From the Guidelines
The probability of tendon rupture with levofloxacin treatment is estimated to be around 15 to 20 per 100,000 treated patients, with certain risk factors such as advanced age, antecedent steroid therapy, and underlying diseases like hypercholesterolemia, gout, rheumatoid arthritis, end-stage renal disease/dialysis, and renal transplantation increasing this risk. According to the study published in Pediatrics 1, tendon rupture is a rare complication associated with quinolone antibiotic agents, with a predilection for the Achilles tendon. The study notes that advanced age, along with antecedent steroid therapy and a particular subset of underlying diseases, have been identified as risk factors and prompted an FDA warning about this serious adverse event for all quinolone agents.
Key points to consider:
- The risk of tendon rupture is higher in patients with certain underlying conditions, such as hypercholesterolemia, gout, rheumatoid arthritis, end-stage renal disease/dialysis, and renal transplantation.
- The Achilles tendon is most commonly affected, though other tendons can also rupture.
- Tendon problems can occur during treatment or even weeks after discontinuation of levofloxacin.
- Patients should stop the medication and seek immediate medical attention if they experience tendon pain, swelling, or inflammation.
- Alternative antibiotics should be considered for high-risk patients when clinically appropriate, especially for conditions that don't require the broad-spectrum coverage that levofloxacin provides, as noted in the study 1.
It's essential to weigh the benefits and risks of levofloxacin treatment, particularly in patients with risk factors for tendon rupture, and to closely monitor them for signs of tendon problems, as recommended by the study 1.
From the FDA Drug Label
Fluoroquinolones, including levofloxacin, are associated with an increased risk of tendinitis and tendon rupture in all ages. The risk of developing fluoroquinolone-associated tendinitis and tendon rupture is further increased in older patients usually over 60 years of age, in those taking corticosteroid drugs, and in patients with kidney, heart or lung transplants Tendinitis and tendon rupture have been reported in patients taking fluoroquinolones who do not have the above risk factors Tendon rupture can occur during or after completion of therapy; cases occurring up to several months after completion of therapy have been reported.
The probability of tendon rupture with levofloxacin treatment is increased, especially in older patients and those with certain risk factors, but the exact probability is not specified in the drug label 2. Key risk factors for tendon rupture include:
- Age over 60 years
- Corticosteroid use
- Kidney, heart, or lung transplants
- Strenuous physical activity
- Renal failure
- Previous tendon disorders It is essential to discontinue levofloxacin if the patient experiences pain, swelling, inflammation, or rupture of a tendon 2.
From the Research
Tendon Rupture with Levofloxacin Treatment
- The probability of tendon rupture with levofloxacin treatment is a significant concern, as highlighted in several studies 3, 4, 5, 6, 7.
- A case study published in 2003 reported a 67-year-old man who developed bilateral Achilles tendon rupture after taking levofloxacin for 10 days, highlighting the potential risk of tendon rupture associated with levofloxacin use 3.
- Another study published in 2016 suggested that levofloxacin may pose a greater risk of tendinopathy compared to other fluoroquinolones, with risk factors including older age, concomitant corticosteroid therapy, and renal dysfunction 4.
- A pharmacovigilance analysis of the FAERS database from 2016 to 2021 found that levofloxacin showed a strong statistical association with tendon rupture, with a median age of 49.88-63.87 years 5.
- A retrospective study of 1 million US senior Medicare beneficiaries found that levofloxacin exhibited a significant increased risk of tendon ruptures, particularly Achilles tendon rupture, within 30 days of use 7.
- The risk of tendon rupture with levofloxacin treatment appears to be exposure-dependent, with higher doses and longer durations of use associated with a greater risk of tendinopathy 4, 5.
- Patient-specific risk factors for fluoroquinolone-associated tendinopathy include older age, receipt of concomitant corticosteroid therapy, presence of renal dysfunction, and history of solid organ transplantation 4.