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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, Moxifloxacin are very commonly used as they are active against a wide range of aerobic gram-positive and gram-negative organisms.
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 continue to experience nerve damage symptoms for more than a year.
Complications of Fluoroquinolone include
- Aortic dissection (tears in aortic wall)
- Aortic aneurysm (rupture)
- Abnormal heart rhythm
- Tendon rupture
- Skin rash
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 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 doctors and patient to discontinue the drug immediately if 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 patient 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 a first choice of medicine for the patients with sinus infections, bronchitis with history of COPD and patients with uncomplicated urinary tract infections.
Evidence to be looked for in potential cases:
- Indications of fluoroquinolone in Medical Records.
- Usage and duration of fluoroquinolone in Pharmacy Records.
- Follow up complications and their treatment after initiation of fluoroquinolone in medical records.
Medical Record Review and claim validation of fluoroquinolone case should take approximately 3 hours in most instances; however, this approximation may vary in cases based on the volume of records.