Severe FDA Warning Against Use of Fluoroquinolone Antibacterial Drugs

ruptured achilles tendon
Side effects of Fluoroquinolones include a ruptured achilles tendon.

The FDA advised on May 13, 2016 that the serious side effects associated with fluoroquinolone antibacterial drugs (Levaguin, Cipro and Avelox) generally outweigh the benefits for patients with sinusitis, bronchitis, and uncomplicated urinary tract infections that have other treatment options. For patients with these conditions, fluoroquinolones should be reserved for those who do not have alternative treatment options.

An FDA safety review has shown that fluoroquinolones when used systemically (i.e. tablets, capsules, and injectable) are associated with disabling and potentially permanent serious side effects that can occur together.

Severe Side Effects

These side effects can involve:

  • Tendon, joint and muscle pain
  • A “pins and needles” tingling or pricking sensationssion
  • Confusion
  • Hallucinations
  • Damage to the central nervous system
John-Ray“The words  ‘serious side effects’ are powerful words for plaintiffs cases,” said John Ray, a leading consultant to the Mass Tort industry for over a decade. “This is a statement of conclusion by the FDA with no equivocation. It is rare for the FDA to make such a definitive statement.”

More than 26 million Americans receive a prescription for a fluoroquinolone antibiotic like Cipro, Levaquin or Avelox each year.

As a result, FDA is requiring the drug labels and Medication Guides for all fluoroquinolone antibacterial drugs to be updated to reflect this new safety information. FDA is continuing to investigate safety issues with fluoroquinolones and will update the public with additional information if it becomes available.

Inadequate warnings

Patients should contact their health care professional immediately if you experience any serious side effects while taking fluoroquinolone medicine. Health care professionals should stop systemic fluoroquinolonetreatment immediately if a patient reports serious side effects, and switch to a non-fluoroquinolone antibacterial drug to complete the patient’s treatment course.

Lawsuits charge that fluoroquinolone antibiotics – principally, Levaquin, Avelox, and Cipro – cause or substantially contribute to the development of irreversible peripheral neuropathy and that defendants’ warnings concerning the alleged risks were inadequate. The involved manufacturers and distributors are 2 Bayer (Cipro and Avelox), Janssen (Levaquin), and McKesson (a distributor).  Minneapolis before Judge Chief Judge John R. Tunheim in MDL No. 2642.

At one time, more than 2,000 Levaquin cases against Johnson & Johnson sat before U.S. District Judge John R. Tunheim in multidistrict litigation (MDL) in Minnesota. Several were settled for confidential amounts, according to court documents. As of March 2015, about 100 were pending in the federal MDL.


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