Levaquin Evaluation Criteria

 

Levofloxacin is a broad spectrum antibiotic of the fluoroquinolone drug class. Levofloxacin is used to treat certain infections such as pneumonia, chronic bronchitis and sinus, urinary tract, kidney, prostate and skin infections. Levofloxacin is also used to prevent in people who may have been exposed to anthrax germs in the air. Levofloxacin is in a class of antibiotics called fluoroquinolones. It works by killing bacteria that cause infections. In 2008 the Food and Drug Administration (FDA) had directed all antibiotic manufacturers making fluoroquinolones to enhance their warning of tendon rupture and damage, but Johnson & Johnson failed to do so, leading to numerous lawsuits by users afflicted with tendon rupture and damage.

Case Evaluation Criteria;

1. Was the patient prescribed Levofloxacin? Reason for prescription?

2. Did the patient have any preexisting conditions, allergies or contraindications for Levofloxacin?

3. Complete Blood Count (CBC) for the Levofloxacin prescribed date should be captured. (Prescribed date)

4. Dosage and Intake details When and where was the injury diagnosed? Whether hospitalized? Dates of hospitalization.

  • Critical Review of Physician Drug Prescription Details
  • Pharmacy Dispensing Details
  • Pharmacy Refill Details
  • Details of Pharmacy Dispensing Details are taken as Confirmatory
  • What was the injury due to Levofloxacin?

5.  What was the injury due to Levofloxacin?

6.  When and where was the injury diagnosed? Whether hospitalized? Dates of hospitalization.

7.  Treatment/management. Any complications

8.  Follow-up visits for treatment/management of injury.

9.  Outcome/prognosis. Resolution of injury?

 

Specific Focus

Identify and report cases with the following scenarios:

  • No Levofloxacin intake
  • No Injuries: Patient took Levofloxacin but did not develop any injuries.
  • Levofloxacin contraindicated in patient but still prescribed.
  • Any medical/surgical history, social history that could have had an effect on the injury

Identify and report on missing medical records Apart from identifying critical missing records that are important for the case, provide a detailed outline on what records are needed, why we need them, how did we get a clue that these records are missing and whether the records missing are confirmatory etc. This will also help in following up and retrieving the records

Missing Records are presented in the following format:

  • What Records/Medical Bills are Needed
  • Hospital/Medical Provider
  • Date/Time Period
  • Why we need the Records/Bills
  • Is Record Missing Confirmatory or Probable?
  • Hint/Clue that records are missing

 Case Overview is provided in the delivery email – relating to

  • Patient name, age
  • Past history
  • Contraindications (if any)
  • Levofloxacin drug details
  • Injury
  • Treatment
  • Complications

Pointers

Case review Template

1)      Chrono to contain details of Levofloxacin intake, diagnosis of musculoskeletal problems(tendinitis, tendon rupture, nerve damage) and subsequent treatment, care and management

2)      Parameters Concerning Levofloxacin Case Review Must Be Filled along with bates ref

  • Our File No – Available in the cover page of the medical records
  • First Name
  • Initial
  • Last Name
  • DOB
  • Medication Taken – Levaquin, Levofloxacin
  • Start Date – From pharmacy records, sample, medical records
  • Dosage
  • Diagnosed with Musculoskeletal problems?  – Yes/no
  • Date of Diagnosis
  • Complication and management of injury
  • Current Condition – Current general medical condition
  • Prior Medical History

 

Levofloxacin – Drug information

Prescribed For:

Levofloxacin is used to treat infections of the sinuses, skin, lungs, ears, airways, bones, and joints caused by susceptible bacteria. Levofloxacin also is frequently used to treat urinary infections, including those resistant to other antibiotics, as well as prostatitis (infection of the prostate). Levofloxacin is effective in treating infectious diarrhea caused by E. coli, Campylobacter jejuni, and Shigella bacteria. Levofloxacin also can be used to treat various obstetric infections, including mastitis (infection of the breast). Inhalational anthrax exposure also is treated with levofloxacin.

Dosing: The usual dose is 250-750 mg given once daily for 3-14 days depending on the type of infection. Anthrax is treated with 500 mg daily for 60 days. It is important to take oral formulations at least 2 hours before or 2 hours after any antacid or mineral supplement containing iron, calcium, zinc, or magnesium since these bind levofloxacin and prevent its absorption into the body.

Injury or side effects: The most frequently reported side events of levofloxacin

Less common side effects include difficulty sleeping, dizziness, abdominal pain, rash, abdominal gas, and itching.

Levofloxacin should not be used in patients with myasthenia gravis. It may cause the condition to become worse. Seek immediate medical attention if you develop muscle weakness or trouble breathing.

Drug Interactions: Iron, calcium, zinc, or magnesium can attach to levofloxacin and other fluoroquinolones and prevent their absorption from the intestine into the blood. Therefore, products (for example, antacids) that contain iron, calcium, zinc or magnesium should be taken at least 2 hours before or 2 hours after levofloxacin. Other drugs that contain these minerals and can similarly interact with levofloxacin include sucralfate (Carafate) and didanosine (Videx, Videx EC).

Taking nonsteroidal anti-inflammatory drugs (NSAIDs) with levofloxacin may increase the risk of CNS stimulation, resulting in over-excitation. There have been reports of changes in blood sugar (increases and decreases) in patients treated with fluoroquinolones and antidiabetic agents. Fluoroquinolones may increase the effect of warfarin (Coumadin).

Generic Name: Levofloxacin

Brands – Levaquin

FDA Safety Warnings:

Brand (Generic) Name

  • Levaquin (levofloxacin) TabletsLevaquin (levofloxacin) Injection
  • Levaquin (levofloxacin in 5% dextrose) Injection
  • Levaquin (levofloxacin) Oral Solution

Sections Modified

MEDICATION GUIDE“new safety information” with the use of Levaquin, particularly the increased risks of tendonitis and tendon rupture.

  • What is the most important information I should know about Levaquin?
    • Tendon rupture or swelling of the tendon (tendinitis)

 

Levaquin History and the FDA– This medication may rarely cause tendon damage (such as tendinitis, tendon rupture) during or after treatment. Your risk for tendon problems is greater if you are over 60 years of age, if you are taking corticosteroids (such as prednisone), or if you have had a kidney, heart or lung transplant. Stop exercising, rest, and get medical help right away if you develop joint/muscle/tendon pain or swelling.

In 2008, Public Citizen filed a petition with the FDA, requesting that stronger warnings be issued regarding Levaquin tendon rupture side effects. The consumer protection group then filed a federal lawsuit asking the court to require the FDA to act on their petition– requesting that new warnings be added about side effects of antibiotics–in accordance with the Administrative Procedure Act.

In July 2008 The Food and Drug Administration (FDA) ordered the Levaquin manufacturer to add a black box warning on the Levaquin label–after it had been associated with tendinitis and ruptured tendons.

The FDA warning states: “Ruptures of the shoulder, hand, Achilles tendon, or other tendons that required surgical repair or resulted in prolonged disability have been reported in patients receiving quinolones, including levofloxacin. Post-marketing surveillance reports indicate that this risk may be increased in patients receiving concomitant corticosteroids, especially the elderly. Levofloxacin should be discontinued if the patient experiences pain, inflammation, or rupture of a tendon. Patients should rest and refrain from exercise until the diagnosis of tendinitis or tendon rupture has been confidently excluded. Tendon rupture can occur during or after therapy with quinolones, including levofloxacin.”

In 2011 another black box warning was required to be added to the packaging of the antibiotics, warning that the drugs could worsen myasthenia gravis symptoms, which is a condition that causes muscle weakness and difficulty breathing when the chest wall muscles are affected.

Signs & Symptoms of Tendon Rupture

The tendon most frequently associated to the Levaquin induced ruptures is the Achilles tendon, however Levaquin has also been linked to tendon ruptures in the rotator cuff (shoulder), the biceps, the hand, and the thumb. Symptoms often associated with an Achilles tendon rupture are:

  • sudden and severe pain
  • swelling and bruising
  • difficulty walking

Signs & Symptoms of Tendinitis

Symptoms of tendinitis that are produced near a joint aggravated by movement include the following:

  • Pain
  • Tenderness
  • Mild swelling, in some cases

Tendinitis in various locations in your body produces these specific types of pain:

  • Tennis elbow causes pain on the outer side of your forearm near your elbow when you rotate your forearm or grip an object.
  • Golfer’s elbow causes pain on the inner part of your elbow.
  • Achilles tendinitis causes pain just above your heel.
  • Adductor tendinitis causes pain in your groin.
  • Patellar tendinitis causes pain just below your kneecap.
  • Rotator cuff tendinitis causes shoulder pain.