The FDA MADE A DECISION!
I have been working on this for almost 2 years! Some great news to share with quinolone sufferers: Finally! The FDA made a decision after almost 2 years since my original citizen petition was filed against quinolones (as did many other people’s petitions against this) class to put a warning on the label and NOT recommend the use of any of the drugs in that class for simple diseases like UTI, sinus infection and alike.
I received a response from them about a year ago that you can read here stating that they were “unable to decide“… whatever that means. Glad they finally were able to decide! It is about time!
The drugs in this class are:
- ciprofloxacin (CIPRO, CILOXAN)
- enoxacin (PENETREX)
- levofloxacin (LEVAQUIN)
- moxifloxacin (AVELOX)
- norfloxacin (NOROXIN, CHIBROXIN)
- ofloxacin(FLOXIN, OCUFLOX)
Please REFUSE any of these in the future since doctors like to override FDA regulations! I personally have these drugs on my “allergic to” list. I recommend you do the same.
Here is the FDA message:
Fluoroquinolone Antibacterial Drugs: Drug Safety Communication – FDA Advises Restricting Use for Certain Uncomplicated Infections
AUDIENCE: Internal Medicine, Family Practice, Pharmacy, Patient
ISSUE: FDA is advising that the serious side effects associated with fluoroquinolone antibacterial drugs generally outweigh the benefits for patients with sinusitis, bronchitis, and uncomplicated urinary tract infections who 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. These side effects can involve the tendons, muscles, joints, nerves, and central nervous system.
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.
See the FDA Drug Safety Communication for a list of currently available FDA approved fluoroquinolones for systemic use.
BACKGROUND: The safety issues described in the Drug Safety Communication were also discussed at an FDA Advisory Committee meeting in November 2015.
RECOMMENDATION: Patients should 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 tendon, joint and muscle pain, a “pins and needles” tingling or pricking sensation, confusion, and hallucinations. Patients should talk with your health care professional if you have any questions or concerns.
Health care professionals should stop systemic 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
Read the MedWatch safety alert, including links to the FDA Drug Safety Communication and previous MedWatch alerts ***here*** (see update below).
The fight is not over yet; there is much more to do. But step 1 is mission accomplished! Now that the FDA admitted that there is a problem, research toward helping the injured can go on!
***Updated on 3/31/2018 since the FDA moved the link to the warnings letter (perhaps removed it) so, instead, I include here a link to the BLACK BOX label of Ciprofloxacin here. This is the actual prescription label now that all healthcare provider receives! This is what it looks like and all other quinolones must have the same label.
Questions are welcomed, as always and they are moderated for appropriateness!