FDA safety alert for Cipro & other fluoroquinolones

 
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PostPosted: Mon Aug 19, 2013 6:31 pm    Post subject: FDA safety alert for Cipro & other fluoroquinolones Reply with quote

Many persons with MS have to have antibiotics prescribed for UTIs, and Cipro has been widely used for quite a few years now.

The US FDA has issued a caution about a possible risk of permanent nerve damage from the fluoroquinolone antibacterial drugs, however.

FDA Safety Alert, August 15, 2013:

Quote:
Fluoroquinolone Antibacterial Drugs: Drug Safety Communication- Risk for possibly permanent nerve damage


ISSUE:

FDA has required the drug labels and Medication Guides for all fluoroquinolone antibacterial drugs be updated to better describe the serious side effect of peripheral neuropathy. This serious nerve damage potentially caused by fluoroquinolones may occur soon after these drugs are taken and may be permanent.

BACKGROUND:

The risk of peripheral neuropathy occurs only with fluoroquinolones that are taken by mouth or by injection. Approved fluoroquinolone drugs include levofloxacin (Levaquin), ciprofloxacin (Cipro), moxifloxacin (Avelox), norfloxacin (Noroxin), ofloxacin (Floxin), and gemifloxacin (Factive). The topical formulations of fluoroquinolones, applied to the ears or eyes, are not known to be associated with this risk.

RECOMMENDATION:

Make sure your patients know to contact you if they develop symptoms of peripheral neuropathy. Make sure your patients receive the Medication Guide with every prescription. If a patient develops symptoms of peripheral neuropathy, the fluoroquinolone should be stopped, and the patient should be switched to another, non-fluoroquinolone antibacterial drug, unless the benefit of continued treatment with a fluoroquinolone outweighs the risk. 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. ...



The alert can be seen here.
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