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Date : 13-08-18 14:01     
 
Writer : HIFU    Views : 34,555
FDA Beefs Up Fluoroquinolone Warning
 
 
Dr. Whang Comments:

I have used variety of Fluoroquinolones for over 20 years in my practice.  I have not seen anyone with peripheral neuropathy described in the FDA warning below.  This is not to say that the physician should ignore it.  It just means that it is another thing we need to tell our patients when we prescribe this class of medication.

In addition, there has been warning re: tendonitis that occurs with this class of medication.  Again, I have never had a patient that developed this but it apparent occurs not too infrequently.

I wish FDA stated how many cases of Fluoroquinolone related peripheral neuropathy actually have been reported of over 30 million prescriptions that were written so that I can have a more realistic Risk profile of this ubiquitous medication.




Infectious Disease
FDA Beefs Up Fluoroquinolone Warning
Published: Aug 15, 2013
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By Michael Smith, North American Correspondent, MedPage Today

The risk of nerve damage that fluoroquinolone antibiotics carry may come on rapidly and perhaps be permanent, the FDA warned Thursday.

The agency said it is requiring an update to the drug labels and medication guides for all systemic fluoroquinolones in order to clarify the risk of peripheral neuropathy associated with the medications.

Peripheral neuropathy -- with symptoms in arms and legs such as pain, burning, tingling, numbness, or weakness -- is a known risk of the drug class and warnings to that effect were added to drug labels in 2004.

But a recent review of data from the Adverse Event Reporting System (AERS) database found that reports of peripheral neuropathy continue to come in despite the warnings.

The reason, the agency said in a safety announcement, appears to be that "the potential rapid onset and risk of permanence were not adequately described."

Approved fluoroquinolone drugs include levofloxacin (Levaquin), ciprofloxacin (Cipro), moxifloxacin (Avelox), norfloxacin (Noroxin), ofloxacin (Floxin), and gemifloxacin (Factive).

The fluoroquinolones have previously been associated with other rare but severe adverse events, affecting the cardiovascular, musculoskeletal, endocrine, and renal systems, as well as the central nervous system.

And the updated warning on peripheral neuropathy comes just a day after researchers in Taiwan described the risk of blood sugar swings in diabetics taking members of the class.

The risk of peripheral neuropathy occurs only with fluoroquinolones that are taken by mouth or by injection, the agency said; the topical formulations of the drugs "are not known to cause this risk."

The FDA urged doctors to switch patients to a nonfluoroquinolone if symptoms of peripheral neuropathy develop, unless the benefit of continued treatment outweighs the risk.

Peripheral neuropathy can occur any time during treatment with fluoroquinolones and can last for months to years after the drug is stopped, the agency said.

In some cases, the FDA added, it can be permanent.
In 2011, the agency reported, about 23.1 million patients had a prescription filled for an oral fluoroquinolone from retail pharmacies. In hospitals about 3.8 million patients were billed for an injectable fluoroquinolone. 



 
 
     
 
 
 
 

 
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