Fluoroquinolones

  • Fluoroquinolone Medical Record Review & Outsourcing Services

Fluoroquinolones are a group of broad-spectrum, systemic antibacterial agents manufactured by Johnson and Johnson and Bayer that have been used to treat conditions like respiratory infections, urinary tract infections, skin infections, sexually transmitted disease. Fluoroquinolone like Ciprofloxacin, Ofloxacin, Norfloxacin, Levofloxacin, and Moxifloxacin are very commonly used as they are active against a wide range of aerobic gram-positive and gram-negative organisms.

The U.S Food and Drug Association (FDA) Adverse Event Reporting System documented that the onset of peripheral neuropathy after starting fluoroquinolones was rapid within few days and even if the drug was stopped, some patients continued to experience nerve damage symptoms for more than a year.

Serious Alleged Injuries may include:

  • Aortic Dissection or Aortic Aneurysm
  • Peripheral neuropathy
  • Angioedema
  • Abnormal heart rhythm
  • Tendon rupture
  • Seizures
  • Skin rash
  • Hallucinations

Lawsuit Allegations:

In July 2008, the FDA issued a "black box" warning to all fluoroquinolone antibiotics indicating that they could increase the risk of tendon ruptures and tendon damage. Although the warning was added to all antibiotics in the class, lawsuits allege that the risk is greatest with levofloxacin (Levaquin) and that Johnson and Johnson failed to properly research their drug or provide reasonable information to the physicians and patients about the risk of having a tendon rupture or tendinitis. Federal levofloxacin lawsuits have consolidated into multidistrict litigation, centralized in the U.S. District Court for the District of Minnesota.

The U.S. FDA issued another warning on August 15, 2013, about the dangers of peripheral neuropathy and instructed the doctors and patient to discontinue the drug immediately if the symptoms of nerve damage occur.

On November 05, 2015, FDA Center for Drug Evaluation and Research, Joint Meeting of the Antimicrobial Drugs Advisory Committee, and The Drug Safety and Risk Management Advisory Committee decided that the current labeling for these drugs was unacceptable, recommending additional study, discussion and action to make both the patients and physicians aware of the potential risks of the drugs, particularly requiring physicians to be more completely informed that fluoroquinolones are not to be used as the first choice of medicine for the patients with sinus infections, bronchitis with history of COPD, and patients with uncomplicated urinary tract infections.

Evidences:

  • Indication of Usage in Pharmacy Records
  • Usage and Duration in Pharmacy Records
  • Follow up complications and their treatment after initiation in medical records

Medical Record Review and claim validation of Fluoroquinolones case should take approximately 6 hours in most instances; however, this approximation may vary in cases based on the volume of records.

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