The FDA has issued an advisory against the use of fluoroquinolone antibacterial drugs, such as Cipro or Avelox, for patients with certain respiratory or urinary tract infections.
“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, fluoroquinolone should be reserved for those who do not have alternative treatment options,” the FDA said in an advisory statement.
An FDA safety review has shown that fluoroquinolones when used systemically (ie 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, we are requiring the drug labels and Medication Guides for all fluoroquinolone antibacterial drugs to be updated to reflect this new safety information. We are continuing to investigate safety issues with fluoroquinolones and will update the public with additional information if it becomes available.
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.
Fluoroquinolone drugs work by killing or stopping the growth of bacteria that can cause illness. The following are currently available FDA-approved fluoroquinolones for systemic use:
|Brand Name||Active Ingredient|
|Cipro extended-release||Ciprofloxacin extended-release|
Hello, my name is Mark Girard and I am the senior admin in Fluoroquinolone Toxicity Group, the largest and busiest of many support groups for victims of FQ toxicity. I was the final speaker before the two separate panels of distinguished physicians voted at the meeting in November. You can listen to all of us in this incredibly heart-wrenching series of testimonies. If you want to cut to my 3 minutes or so, go to 1:49:30, but it’s really much better if you hear the whole thing, and I think that if you are going to hand fluoroquinolones to people that you really should listen to us first. The doctors were clearly quite shocked to find out that this has been happening and now the FDA has responded within half a year or so, which is actually lightning speed in the world of government agencies. We still have a long way to go before doctors will be using these drugs as judiciously as they should be, but this is a big step in the right direction. Best wishes to all of you! Mark A Girard
As a member of the healthcare community I would like to share my personal experience with Fluoroquinolone Antibiotics. I had been given Cipro in the winter of 2013 for a suspected, unconfirmed, uncomplicated bout of bronchitis. At the time, I was in my early 40s and passionate about running. I seemed to tolerate the Cipro well and the bronchitis resolved.
Within three months of finishing the antibiotic I sustained three spontaneous tendon ruptures ( supraspinatus, infraspinatus and biceps long head was transected at the nerve root). I had no previous trauma and the tears were full thickness necessitating surgery. I had the surgery and spent months regaining my ROM and strength — I returned to 100%.
In October of 2014 I again had uncomplicated, unconfirmed bronchitis. Because I worked with a mostly geriatric population I again took the prescription offered , Cipro, in order to return to work as quickly as possible. While taking Cipro I began to experience deep hip pain, knee pain, and ankle pain. I did not ascribe those symptoms to the Cipro – I though perhaps that the change in weather and increase in excercise may have caused some irritation. By the end of November the pain was so disabling that I took a week off from work and went to see a Rheumatologist. I had a full workup that revealed I had no underlying illness. The Rheumatologist was surprised by my results until he asked if I had taken any medications in the previous year. ” Only an antibiotic,” I replied – ” Only Cipro.”
Well, this Rheumatologist who was located in the NY Metropolitan area had seen cases of Fluoroquinolone adverse reactions before. He acknowledged both his suspicions of my diagnosis and shared that he had no knowledge of any cure.
I have spent the past 19 months trying desperately to heal. The first six months I was unable to walk any distance at all or to stand for more than a few minutes. I went from running miles and miles at competitive speeds to being disabled. As a result I finally was forced to tale an exended leave from work. I suffered not only tendon pain and rupture and joint pain but peripheral neuropathy, insomnia and anxiety. I was affected in multiple systems.
Because of my background I was able to research PubMed articles and connect with professionals at multiple teaching hospitals in the NY area. Finally I was directed to two physicians at Indiana University Medical Center. After forwarding my history and file these physicians consulted with my NY Rheumatologist and confirmed his diagnosis. They shared that there is no cure, no projected timeline for recovery – that, in fact, given the severity of my symptoms and the length of time since the course of treatment that my prognosis for recovery was, in their words, “bleak”.
I am now 19 months out from my last dose and while I can walk I am still unable to function at a level to permit me to return to my profession. I continue to experience profound pain and my tendonopathy endures with more ruptures and poor healing. Continued, regular bloodwork still reveals no other disease process or abnormality — in fact my bloodwork is perfect.
Today’s announcement by the FDA is validation that the risks of this drug class far outweighs it’s benefits. To use an elephant gun to kill a mosquito is poor practice of medicine. My heart goes out to all those who have been needlessly injured, disabled, or killed by the indiscriminate prescribing of Fluoroquinolone Antibiotics.
The victims deserve the full support of the medical community.
Thank you for continuing to update the public on these toxic drugs. Hopefully now this will spur some investigation of what these drugs have actually done to our bodies, DNA & Mitochondria! The warnings need to be added for Pets & Babies. Yep, Ciprodex is harming people the same way and it’s given to babies all the time. Pets are being harmed too.