This case involves a patient who died nine months after taking 750mg of Levaquin for five days. The drug was prescribed for a suspected urinary tract infection, urolithiasis, and bronchopneumonia by an advanced nurse practitioner at an urgent care clinic. Though there was some ambiguity over whether the pneumonia may have developed Legionella, the nurse decided to treat is as a brochopneumonia manifestation. The patient was a sixty-six-year-old who had been diagnosed with end-stage renal failure and was on peritoneal dialysis at night. The Levaquin instructions advised caution when prescribing in presence of renal insufficiency and recommended no more than one initial dose of 750mg with subsequent doses of 500mg every forty-eight hours.

The metabolism and excretion of many drugs and their pharmacologically active metabolites depend on normal renal function. Accumulation and toxicity can develop rapidly if dosages are not adjusted in patients with impaired renal function. In addition, many drugs that are not dependent on the kidneys for elimination may exert untoward effects in the uremic milieu of advanced renal disease. A familiarity with basic pharmacologic principles and a systematic approach are necessary when adjusting drug dosages in patients with abnormal kidney function. The distinct steps involve calculating the patient's glomerular filtration rate, choosing and administering a loading dose, determining a maintenance dose, and a decision regarding monitoring of drug concentrations. If done properly, therapy in renal patients should achieve the desired pharmacologic effects while avoiding drug toxicity.

1. How could this situation of drug toxicity be avoided in patients that have renal impairment?

Location: Washington B.S.N, Moorhead State University M.S., Nursing, University of Washington, Graduate School of Nursing Post Graduate Study, Nurse Practitioner, University of Washington M.B.A., Pacific Lutheran University Certification: ACLS, Critical Care Nurse, Adult Nurse Practitioner Former R********* N**** C****** R************* S**** P**** H******* Former R********* N**** I** S**** P**** H******* Former A******** P******** N****** S**** M******** C****** Current R********* N**** I** a* m**** r******* m****** c*****

This certified adulty nurse practitioner holds a master's degree in nursing, as well as an M.B.A. She has remained in active practice for over 20 years, and currently functions as an ICU nurse at a major healthcare center.

Unadjusted Dose of Antibiotics Causes Death

This case involves a forty-five-year-old female patient who had a medical history of asthma but otherwise was in fairly good health. The patient presented to her PCP with chills and shortness of breath. It was at this point she was treated with Prednisone and Levaquin. After 3 days, the patient presented to the ER when she felt like she was choking, with a lump-like sensation in her throat. The patient experienced significant difficulty breathing and also noticed a prevalent rash on her right arm that eventually spread, covering her entire body.The patient had significant wheezing and the differential diagnosis at the time of admission was COPD / Pneumonia / Bronchitis. Lab studies were never ordered and the ER physician decided to prescribe another 500MG IV dosage of Levaquin for the patient. An unspecified allergic reaction was noted in the emergency room, but they continued to infuse the medication that was causing the severe and uncontrolled inflammatory reaction. When the patient was transferred to the medical floor, she rapidly deteriorated and it was discovered that she was suffering from Stevens-Johnson syndrome.

There are no specific laboratory studies (other than biopsy) that can definitively establish the diagnosis of Stevens Johnson syndrome. However, the following are typically elevated in patient with SJS: Tumor necrosis factor (TNF)-alpha, Soluble interleukin 2-receptor, Interleukin 6, and C-reactive protein. The additional dose of Levaquin could very well have been the agent that put the patient over the edge as antibiotics are the most common cause of Stevens-Johnson syndrome, followed by analgesics, cough and cold medication, NSAIDs, psychoepileptics, and antigout drugs. Of antibiotics, penicillins and sulfa drugs are prominent; ciprofloxacin and levofloxacin (Levaquin) have also been reported to be a cause of the syndrome.

What is the standard of care in identifying SJS in a timely manner and did the additional dose of Levaquin exacerbate the condition?

Location: Ohio B.A., University of Virginia M.D., Georgetown University Residency, Emergency Medicine, University of Cincinnati Hospital Fellowship, Postdoctoral Fellow, Naval Research Laboratory Board Certification: Emergency Medicine Member, Society of Academic Emergency Medicine Member, American College of Emergency Physicians Member, Ohio State Medical Association Research, 10+ major grant funded research projects Former F****** C***** H******* Former A******** P******** E******** M******* U********* o* C********* Current A***** M****** S**** f** 3 m**** r******* h******* c****** Current A******** P******** D********* o* E******** M******* a* m**** m****** i********** Current A******* R******* I************ S***** C*********

This expert is a board certified emergency medicine physician who has remained in active practice for 12 years. He currently works in both an academic medical center, and in a community hospital, making him qualified to opine on the standard of care as it pertains to the practice of emergency medicine in the ER. Furthermore, he has also pursued several major research projects in his field, and holds an assistant professorship in emergency medicine at a major medical institution in Ohio.

Stevens Johnson Syndrome Goes Untreated in Patient

This case involves a fifty-six-year-old male who suffered an Achilles tendon rupture as a result of being prescribed Levaquin. The patient was referred to an ENT after he started experiencing fever, headache, and dull facial pressure. The diagnosis of sinusitis was made and he was started on Levaquin. The physician explained that his symptoms should start to subside. However, the physician never warned of any side effects he may encounter with the antibiotic. He scheduled the patient to return in two weeks to assess response to treatment. A few days later, the patient began to feel better and resumed his normal activities. One activity he enjoyed was running for thirty minutes around his neighborhood. As he was turning a corner, the man felt as sharp pop in his right foot, just above his heel. He described it like he was shot with a bullet there. He then walked home to find that his ankle was swollen. Due to the extreme pain, the man went to the emergency department where they diagnosed him with a complete ruptured Achilles tendon. After further questioning, it was discovered that the patient was prescribed Levaquin and was not warned about potential side effects. The emergency medicine physician told the man that his ruptured tendon was probably due to Levaquin. The patient had to undergo surgery the next day to repair the ruptured tendon.

This physician failed to mention the potential risk of tendon rupture, let alone any side effects. Some side effects associated with Levaquin and the class of drugs it falls under includes GI upset (nausea, vomiting, diarrhea, dizziness, rash, tendinopathy and rupture, liver damage, and arrhythmias). The US Food and Drug Administration (FDA) requires drug manufacturers to include a boxed warning regarding the increased risk of tendinopathy and tendon rupture associated with fluoroquinolones (drug class Levaquin falls under). The FDA recommends that, at the first sign of tendon pain, swelling, or inflammation, patients should stop taking the fluoroquinolone, avoid exercise and use of the affected area, and promptly contact their physician for tendon evaluation and transition to a non-fluoroquinolone antibiotic. To avoid injury in this patient, the ENT physician should have first warned the patient of the potential side effect. Secondly, he should have recommended that the patient avoid exercise and other strenuous activity while on Levaquin.

Did this physician practice the standard of care when prescribing this medication, what could have been done to prevent further harm to the patient?

ENT Fails to Mention Adverse Side Effect

This case takes place in Rhode Island and involves a 41-year-old female who had been scheduled for an appendectomy and a hysterectomy / bilateral salpingo-oophorectomy. The surgery was uneventful and the patient was scheduled for discharge from the hospital on the next day. After the surgery, and before discharge, the patient experienced an elevated white blood cell count of 24 on the day after surgery and 20 on the following day. The patient also experienced difficulty breathing after surgery. A chest x-ray taken two days after surgery revealed infiltrates in the right lower lobe of her lung. The patient had contracted a serious blood infection referred to as an anaerobic septicemia. She was nevertheless discharged home with a prescription for Zithromax, and set for an office visit in 2 weeks.

In the days after her discharge she began experiencing an altered mental status. Four days after the surgery she was brought back to the hospital by her family and was admitted, at which point she came under the care of her family doctor. She was given medications to calm and sedate her, and a stronger antibiotic, Levaquin. No tests were done to determine the cause of the respiratory problem, and her blood oxygenation and related vital signs were not watched adequately. Two days after she was admitted she began experiencing severe respiratory distress, but repeated complaints by the patient and her family were ignored by the nursing staff, until the patient began to turn blue. Later that day she was ordered to be transferred to the ICU. By the time adequate treatment had begun, the patient’s blood oxygen saturation had fallen to 42, and her brain had been deprived of oxygenation for an extended period. As a result, she suffered permanent brain damage.

I do believe that the treating physician should have recognized the patient’s symptoms as suspicious for infection. Further investigations were warranted prior to discharge. Based on the case summary it seems that there was potential negligence on the part of the defendant. This is a very bad outcome and falls below the standard of care. At first brush, without seeing the medical records, the event timeline based on the brief summary of the case suggests the need for a more vigorous work-up and aggressive treatment for this patient, prior to her initial release and even after her second admission. The differential of post-op shortness of breath and mental status changes would have included pulmonary embolus as well as infectious or medication-induced; a chest x-ray suggesting pneumonia and a significantly elevated white count would have certainly made infection a more likely diagnosis. Her altered mental status at readmission should have prompted an aggressive evaluation as well, particularly in light of her recent diagnosis of septicemia. Clearly, a delay in recognizing the gravity of the problem contributed to her permanent encephalopathy. This apparent issue comes down to physician judgment regarding the timing of the discharge and follow-up (one to two days vs. two weeks). Judgment is also in question with re-admission with progressive symptoms that were not apparently evaluated and were attributed to psychiatric causes versus medical. The respiratory and infectious issues and possible causes of the altered mental status clearly needed to be addressed first and thoroughly before considering psychiatric issues as the cause of the altered mental status.

1.) Do you believe the OB-GYN caring for this patient should have recognized symptoms of infection, which warranted further investigation prior to initial discharge? 2.) As the patient’s family medicine physician (knowing the patient and her family well for many years), should the physician have further investigated the cause / origin of the patients altered mental status?

Location: Texas B.A., Austin College M.D., Baylor College of Medicine Residency, Obstetrics and Gynecology, Baylor College of Medicine Board Certified, American Board of Obstetrics and Gynecology Member, American Association of Gynecologic Laparoscopists Member, American College of Obstetrics and Gynecology Member, Texas Association of Obstetrics and Gynecology Member, Texas Medical Association Former, Assistant Chief, Northwest Methodist Hospital Former, Chief of Staff, Methodist Women's and Children's Hospital Former, President, private Ob/Gyn practice Current, Associate Professor, Department of Obstetrics and Gynecology, major medical university Current, Ob/Gyn Staff, major surgery center

Northeast

Rhode Island

This board certified expert has been practicing for over 40 years. He received his medical degree from Baylor University's College of Medicine prior to completing his residency in Obstetrics and Gynecology there as well. He holds membership in numerous distinguished medical and gynecologic organizations, and his work has been published in journals such as the "Journal of Reproductive Medicine" and "Obstetrics and Gynecology". He was the President of his own private practice for 24 years, during which he served as a member of the Ob/Gyn staff at multiple hospitals and was the Chief of Staff at Methodist Women's Children's Hospital. Currently, this expert is part of the Ob/Gyn staff at a major surgery center as well as an Associate Professor in the Department of Obstetrics and Gynecology at a major medical university.

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Levaquin Expert Witness Case Studies

Unadjusted Dose of Antibiotics Causes Death

Stevens Johnson Syndrome Goes Untreated in Patient

ENT Fails to Mention Adverse Side Effect

OB-GYN Fails to Recognize Symptoms of Infection

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