A presentation I gave during an internship/Advanced Pharmacy Practice Experience (APPE) for institutional pharmacy at a community hospital.

1. Effects of
Fluoroquinolones on
Outcomes of Patients with
Aortic Dissection or
Aneurysm: An Analysis
Paul Pasco,
PharmD Candidate
UTHSC College of
Pharmacy
April 13, 2021

2. Background
Systemic fluoroquinolones (FQs) have a well-established side effect profile
ADRs include:
• Hypoglycemia
• Hyperglycemia
• QTc prolongation
• Tendinitis/tendon rupture (BBW)
• CNS effects (e.g., delirium) (BBW)
• Peripheral neuropathies (BBW)
• Exacerbation of myasthenia gravis (BBW)
2
US Food & Drug Administration. FDA updates warnings for fluoroquinolone antibiotics on risks of mental health and low blood sugar adverse reactions. FDA News Release.
Published July 18, 2018. Accessed April 13, 2021. https://www.fda.gov/news-events/press-announcements/fda-updates-warnings-fluoroquinolone-antibiotics-risks-mental-
health-and-low-blood-sugar-adverse

3. Systemic
Fluroquinolones
3
Ciprofloxacin (Cipro®)
Levofloxacin (Levaquin®)
Moxifloxacin (Avelox, Avelox IV®)
Ofloxacin (Floxin®, Floxin IV®)
Delafloxacin (Baxdela®)

4. Previous
Research
4
Population-based studies have
demonstrated that FQs are
correlated with an increased risk of
developing an aortic dissection (AD)
and/or aortic aneurysm (AA)
The effect of FQs on outcomes had
not been previously studied in
those with a preexisting AD or AA
1. Chen S-W, Chan Y-H, Chien-Chia V, et al. Effects of Fluoroquinolones on Outcomes of Patients With Aortic Dissection or Aneurysm. Journal of the American College of
Cardiology. 2021;77(15):1875-1887. doi:10.1016/j.jacc.2021.02.047

5. Study
Design
5
Objective: Explore whether FQ use increases the
risk of aortic-related adverse events and/or death
Retrospective cohort study
Conducted with Taiwan National Health Insurance
Research Database
Included 31,570 adult patients with AD or AA
Conducted with data from 2001 to 2013
Amoxicillin used as a negative control
1. Chen S-W, Chan Y-H, Chien-Chia V, et al. Effects of Fluoroquinolones on Outcomes of Patients With Aortic Dissection or Aneurysm. Journal of the American College of
Cardiology. 2021;77(15):1875-1887. doi:10.1016/j.jacc.2021.02.047

6. Results: Self-Control Design
FQ exposure was correlated with:
• 61% higher risk of all-cause mortality compared to amoxicillin (adjusted hazard ratio: 1.61,
95% confidence interval: 1.50 to 1.73)
• 80% higher risk of death related to aortic causes (adjusted hazard ratio: 1.80 95% confidence
interval: 1.50 to 2.15)
• 49% higher risk of requiring aortic surgery (adjusted hazard ratio 1.49, 95% confidence
interval: 1.24-2.06)
• 64% higher risk of requiring an aortic stent (adjusted hazard ratio 1.64, 95% confidence
interval: 1.30-2.06)
6
1. Chen S-W, Chan Y-H, Chien-Chia V, et al. Effects of Fluoroquinolones on Outcomes of Patients With Aortic Dissection or Aneurysm. Journal of the American College of
Cardiology. 2021;77(15):1875-1887. doi:10.1016/j.jacc.2021.02.047

7. Results: Active-Comparator Design
FQ exposure was correlated with:
• 73% higher risk of all-cause mortality compared to amoxicillin (adjusted hazard ratio: 1.73,
95% confidence interval: 1.52 to 1.96)
• 99% higher risk of death related to aortic causes (adjusted hazard ratio: 1.99 95% confidence
interval: 1.44 to 2.75)
• 34% higher risk of requiring aortic surgery (adjusted hazard ratio 1.34, 95% confidence
interval: 1.03-1.75)
• 48% higher risk of requiring an aortic stent (adjusted hazard ratio 1.48, 95% confidence
interval: 1.05-2.08)
Amoxicillin was not significantly associated with any of these outcomes
A subgroup analysis demonstrated that these effects of FQs did not differ between AD and AA groups
7
1. Chen S-W, Chan Y-H, Chien-Chia V, et al. Effects of Fluoroquinolones on Outcomes of Patients With Aortic Dissection or Aneurysm. Journal of the American College of
Cardiology. 2021;77(15):1875-1887. doi:10.1016/j.jacc.2021.02.047

8. Conclusions
8
Lends further credence that FQs should be
reserved for more serious bacterial infections
(e.g., bacterial pneumonia) versus
uncomplicated SSTIs
Must continue to assess risks versus benefits
of therapy carefully
Initiation of therapy in patients with AD or AA
should bear additional scrutiny
SSTIs = Skin and soft tissue infections

9. Effects of
Fluoroquinolones on
Outcomes of Patients with
Aortic Dissection or
Aneurysm: An Analysis
Paul Pasco,
PharmD Candidate
UTHSC College of
Pharmacy
April 13, 2021