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Legal Lessons: Risks of Medications

Matthew DeLaney, MD and Mike Weinstock, MD
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Patients who have cellulitis should have antibiotics selected based on potential for treatment of the cellulitis as well as risks of side effects of the antibiotic.

Fluoroquinolone antibiotics have come under increasing scrutiny as we have become more aware of the growing list of possible adverse reactions. In this segment, Mike and Matt discuss a lawsuit that resulted from questionable use of a fluoroquinolone and offer several lessons surrounding prescription of these antibiotics. 

 Pearls:

  • Fluoroquinolones have multiple black box warnings and malpractice plaintiffs attorneys actively solicit patients who have had adverse reactions to pursue legal action.

  • Considering the patient’s age, gender, and other comorbidities can offer insight into that patient’s individual risk of various complications.

  • In addition to the known concern for tendonopathy, evidence over recent years suggests fluoroquinolones increase the risks of psychiatric condition, CNS and peripheral neuropathy, hypoglycemia, and aortic catastrophe. 

  • Using shared decision making, obtaining informed consent, and documenting a risk vs. benefit rationale can mitigate risk to the patient and medicolegal risk to the provider when prescribing fluoroquinolones.  

CASE:

A patient with recent knee replacement sustained a laceration when he dropped a heavy metal object on his foot that became infected. He saw his orthopedic surgeon who prescribed cephalexin. The patient then was sent to UC for a tetanus shot. The tetanus shot was given by the UC provider (also the defendant) and the antibiotic was switched to levofloxacin. As a complication of taking levofloxacin, the patient suffered an Achilles’ tendon rupture. 

The patient then pursued legal action against the UC physician for not counseling him about the risks of quinolone antibiotics. 

  • Fluoroquinolones carry a significant risk of many types of adverse events and have been given multiple “Black Box” warnings by the FDA.

    • The known adverse events associated with fluoroquinolone use include: QTc prolongation, cognitive changes, psychiatric complications, tendon rupture, aortic pathology including dissection and aneurysm rupture, peripheral neuropathy, and hypoglycemia.

  • Since a successful 2010 lawsuit for tendon rupture, the FDA has added additional black box warnings resulting in a dramatic increase in plaintiffs attorneys soliciting cases of plaintiffs who have experienced adverse effects of quinolone antibiotics. 

  • When prescribing a quinolone antibiotic, it is important to determine if the many possible risks associated with fluoroquinolone are justified, especially because there are usually other, less toxic, options.

    • The risk versus benefit decision making will be patient specific based on the patient’s other underlying medical conditions and age. 

      • The risk of tendon rupture seems to be greatest in patients >60 years, men, patients taking corticosteroids, and patients with chronic renal disease.

      • Patients with known aortic aneurysm or a history of Marfan’s syndrome, for example, will likely have a higher ring risk of aortic complications resulting from quinolone treatment. 

      • Although there is not direct evidence to support this, it is also reasonable to suspect that patients with existing CNS disease, peripheral neuropathy, and/or psychiatric conditions will also be more likely to have these exacerbated when taking a quinolone

  • It is somewhat protective to chart a risk vs. benefit calculation if electing to prescribe a fluoroquinolone.

    • E.g. “While fluoroquinolones do carry risk of tendinopathy, neuropathy, QTC prolongation etc., I feel that because of X (e.g. allergies to other antibiotics, concern for pseudomonas, tolerance of a quinolone previously), the possible benefits exceed the risk in this patient.

  • Having a shared decision making conversation and obtaining informed consent before prescribing fluoroquinolones (and documenting this) helps to ensure patients are aware of the risks.

 

REFERENCES:

  1. Davidson BL et al. Bleeding Risk of Patients With Acute Venous Thromboembolism Taking Nonsteroidal Anti-Inflammatory Drugs or Aspirin. JAMA Intern Med. 2014;174(6):947-953. doi:10.1001/jamainternmed.2014.946

  2. Corrao G, et al. Evidence of tendinitis provoked by fluoroquinolone treatment: a case-control study. Drug Saf 2006;29:889-96. PMID: 16970512

  3. U.S. Food and Drug Administration. FDA updates warnings for fluoroquinolone antibiotics on risks of mental health and low blood sugar adverse reactions. July 10, 2018. https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm612995.htm

  4.  DeLaney MC. Risks associated with the use of fluoroquinolones. Br J Hosp Med

(Lond). 2018 Oct 2;79(10):552-555. doi: 10.12968/hmed.2018.79.10.552. PubMed

PMID: 30290736..

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