FDA Requires New Black Box Warnings Restricting Fluoroquinolone Usage

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The following is from http://www.fda.gov/Safety/MedWatch/...tyAlertsforHumanMedicalProducts/ucm513065.htm:

Fluoroquinolone Antibacterial Drugs for Systemic Use: Drug Safety Communication - Warnings Updated Due to Disabling Side Effects

Including the following currently available fluoroquinolones

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

[Posted 07/26/2016]

AUDIENCE: Family Practice, Infectious Disease, Neurology, Pharmacy, Patient

ISSUE: FDA approved changes to the labels of fluoroquinolone antibacterial drugs for systemic use (i.e., taken by mouth or by injection). These medicines are associated with disabling and potentially permanent side effects of the tendons, muscles, joints, nerves, and central nervous system that can occur together in the same patient. As a result, FDA revised the Boxed Warning, FDA’s strongest warning, to address these serious safety issues. In addition, FDA updated other parts of the drug label including the Warnings and Precautions and Medication Guide sections.

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.

FDA is continuing to assess safety issues with fluoroquinolones as part of FDA’s usual 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.

BACKGROUND: The labels of fluoroquinolone medicines already have a Boxed Warning for tendinitis, tendon rupture, and worsening of myasthenia gravis. The labels also include warnings about the risks of peripheral neuropathy and central nervous system effects. Other serious risks associated with fluoroquinolones are described in the labels, such as cardiac, dermatologic, and hypersensitivity reactions. After FDA’s 2013 review that led to the additional warning that peripheral neuropathy may be irreversible, FDA 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

RECOMMENDATION: 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 List of Serious Side Effects from Fluoroquinolones in the FDA Drug Safety Communication).

Health care 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.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

• Complete and submit the report Online: www.fda.gov/MedWatch/report
• Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

[07/26/2016 - Drug Safety Communication - FDA]

Previous MedWatch Alert:

[05/12/2016 - Fluoroquinolone Antibacterial Drugs: Drug Safety Communication - FDA Advises Restricting Use for Certain Uncomplicated Infections]

 

[GreyOwl]

@Gingergrrl FYI

 

[Gingergrrl]

Thanks for tagging me @GreyOwl and I missed this one although I get daily alerts from Google re: Levaquin. Am glad they are making the warnings stronger but afraid most doctors will either ignore the warnings, will not see them at all, or will never inform their patients. I think the damage I suffered is too late to correct although I want to believe differently!

 

[Justin30]

Its about time. These drugs can really mess u up.

Had I know the affcets of these in the past when I was younger I would have never used them.

 

[cfs6691]

Its about time. These drugs can really mess u up.

Had I know the affcets of these in the past when I was younger I would have never used them.

I had a quick look and I found that they are highly hepatotoxic.Were you aware of potential liver injury among the negative effects of fluoroquinolones?

 

[cfs6691]

I have read about the liver when I did my own research almost 20 years ago and I suspect that there are a few cases of undiagnosed liver disease/damage among those of us who have been diagnosed with CFS,I can quote from medical journals regarding the unreliability of blood tests in order to rule out liver disease,there also similarities in symptoms and epidemiology.The liver detoxifies chemicals and what happens if its capacity to do that has been compromised has not been studied and recently I discovered that the liver also plays a role in inflamation response(that also doesn't seem to have been explored)I can discuss these topics in more detail some other time if you are interested.If you have had an adverse reaction to other medications or chemicals,if you have done genetic testing and you are a slow metabolizer to medications that you have taken and developed an adverse reaction to if you have had an illness caused by viruses known to have the capacity to cause liver damage including Epstein-Barr maybe you can discuss with your doctors the possibility of doing a liver biopsy since another alternative test to blood tests has not been developed.It is an invasive procedure and I don't even know if the option is available or if there are enough factors to justify a liver biopsy,I can only provide quotes from old journals since in the past doctors paid more attention to the liver and were not as blase and know-it-alls as today.