Updated FDA Black Box Warning for Fluoroquinolone Antibacterial Drugs

Achilles-tendon-ruptureThe FDA revised the Boxed Warning, its strongest warning, about fluoroquinolone antibacterial drugs to address side effects including permanent damage to the tendons, muscles, joints, nerves, and central nervous system — which can occur together in the same patient.

On July 26, 2016, the FDA identified the specific drugs:

  • Avelox (moxifloxacin)
  • Cipro (ciprofloxacin)
  • Cipro extended-release (ciprofloxacin extended-release)
  • Factive (gemifloxacin)
  • Levaquin (levofloxacin)
  • Ofloxacin (generic brand)

The Fluroroquinolones MDL 2642, which includes complaints related to Levaguin, Cipro and Avelox related to peripherial neruropathy have been transfered to the same court (District of Minnesota) and the same Judge (John R Tunheim) as the Levaquin MDL 1943 related to tendon ruptures.

Cases Pending

 

For an update, read:

After Science Day, Flouroquinolone Litigation Heads Toward Settlement

Defense counsel reported that there are currently 18 cases pending in the MDL. The DeFelice case is active and in the process of discovery. The Watson case is settled and paperwork is being prepared for dismissal. Ten other cases are waiting for paperwork and will soon be ready for dismissal. Defense counsel reported that in six pending cases, the parties previously reached a settlement, but defense counsel never received final paperwork. Defense counsel sent plaintiffs’ counsel letters requesting that they attend the next status conference. In four out of the six cases, defense counsel successfully made contact with counsel for the plaintiffs, and they hoped to finalize the paperwork soon.

With regard to the remaining two cases, Castillo and Ditolla, defense counsel did not hear back from plaintiffs’ counsel. The Court agreed that defense counsel should prepare the papers for orders to show cause and submit them to the Court.

Defense counsel reported that in six pending cases, the parties previously reached a settlement, but defense counsel never received final paperwork. Defense counsel sent plaintiffs’ counsel letters requesting that they attend the next status conference. In four out of the six cases, defense counsel successfully made contact with counsel for the plaintiffs, and they hoped to finalize the paperwork soon.

Remand/Transferred Cases

Defense counsel reported that of the cases transferred or remanded 52 had settled, 19 were dismissed, and 19 remained open.

In the Tummolo Case, Plaintiff’s counsel Jacqueline Olson stated that a few years ago certain documents were not sent to the defendants, which resulted in dismissal. Olson says =that she would like the case put back on active calendar and intended to apply to have the case restored.

Defense counsel Tracy Van Steenburgh and Cort Sylvester said that the case is currently dismissed and that Plaintiff would need to file a motion to vacate the dismissal, which defense counsel would decide whether to oppose. The Court stated that plaintiff should file a motion to vacate with supporting reasons within the next two weeks, after which the defense counsel would have an opportunity to respond.

Black Box Warning

The FDA also updated other parts of the drug label including the Warnings and Precautions and Medication Guide sections.

The agency is continuing to assess safety issues with fluoroquinolones as part of its ongoing review of drugs and will update the public if additional actions are needed. See the FDA Drug Safety Communication for additional information, including a Data Summary and Additional Information for Health Care Professionals and Patients.

The labels of fluoroquinolone medicines already have:

  • A Boxed Warning for tendinitis, tendon rupture, and worsening of myasthenia gravis.
  • Warnings about the risks of peripheral neuropathy and central nervous system effects.
  • Labels that warn of other serious risks such as cardiac, dermatologic, and hypersensitivity reactions.

After FDA’s 2013 review that led to the additional warning that peripheral neuropathy may be irreversible, it evaluated post-marketing reports of apparently healthy patients who experienced disabling and potentially permanent side effects involving two or more body systems after being treated with a systemic fluoroquinolone

FDA has determined that fluoroquinolones should be reserved for use in patients who have no other treatment options for acute bacterial sinusitis, acute exacerbation of chronic bronchitis, and uncomplicated urinary tract infections because the risk of these serious side effects generally outweighs the benefits in these patients. For some serious bacterial infections the benefits of fluoroquinolones outweigh the risks, and it is appropriate for them to remain available as a therapeutic option.

Patients must contact your health care professional immediately if you experience any serious side effects while taking your fluoroquinolone medicine. Some signs and symptoms of serious side effects include unusual joint or tendon pain, muscle weakness, a “pins and needles” tingling or pricking sensation, numbness in the arms or legs, confusion, and hallucinations. Talk with your health care professional if you have any questions or concerns (see the List of Serious Side Effects from Fluoroquinolones in the FDA Drug Safety Communication).

Healthcare professionals should not prescribe systemic fluoroquinolones to patients who have other treatment options for acute bacterial sinusitis (ABS), acute bacterial exacerbation of chronic bronchitis (ABECB), and uncomplicated urinary tract infections (UTI) because the risks outweigh the benefits in these patients. Stop fluoroquinolone treatment immediately if a patient reports serious side effects, and switch to a non-fluoroquinolone antibacterial drug to complete the patient’s treatment course.

Larry Bodine

Attorney Larry Bodine is Editor of Mass Tort Nexus, and the Editor of The National Trial Lawyers. He is the former Editor in Chief of Lawyers.com and the American Bar Association Journal. He is a cum laude graduate of both Seton Hall University Law School and Amherst College.

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