The ONLY FDA approved uses for fluoroquinolones in children are:
- Anthrax
- Plague
- Complicated urinary tract infections
That’s it.
All other uses of fluoroquinolones in children are off-label. All pediatric fluoroquinolone prescriptions for treatment of sinus infections, uncomplicated urinary tract infections, respiratory infections, diarrhea, ear infections, etc. are off-label. The FDA has not done a cost-benefit analysis, or a safety analysis, for any use of fluroquinolones in children, other than for treatment of anthrax, plague, and complicated urinary tract infections.
The reason that fluoroquinolones are not approved for most pediatric uses is because, “Fluoroquinolone-induced joint/cartilage toxicity has been observed in juvenile animal studies and is species- and dose-specific with canines exhibiting the highest rate of arthralgias. These early observations led to the contraindication of fluoroquinolones in the pediatric population” (source). Additionally, serious musculoskeletal and nervous system adverse reactions occur at higher rates in children treated with fluoroquinolones than children treated with other antibiotics (source). To put it into simple terms, fluoroquinolones have been shown to cause lameness, stunted growth, joint pain, and other permanent musculoskeletal problems in experiments on juvenile mammals (beagle puppies).
Despite the evidence that fluoroquinolones can cause irreparable musculoskeletal damage to juvenile mammals, there are some people who argue that fluoroquinolone use should be expanded in the pediatric population. Additionally, fluoroquinolones ARE prescribed to children, despite the fact that they cause lameness and arthralgia in animals, and the fact that there are no FDA approved indications for fluoroquinolones other than anthrax, plague, and complicated urinary tract infections.
The Hippocratic Oath and the precautionary principle should be the guiding thought processes when prescribing drugs to children. Drugs that have been shown to cause lameness in juvenile animals, and that have multiple black-box warnings on them, should not be given to children. The current black-box warning for fluoroquinolones states that they can cause “disabling and potentially irreversible serious adverse reactions.” No child should be subjected to even the risk of permanent musculoskeletal problems that could result in disability.
Yet… children are being prescribed fluoroquinolones every day, and they are being put at risk. Because of hubris and the general acceptance of off-label prescribing in medicine, many doctors are subjecting children to the risk of fluoroquinolone toxicity–a constellation of symptoms that includes not only serious musculoskeletal problems, but also autonomic nervous system dysfunction, neuropathy, psychiatric disturbances, blood-sugar irregularities, and more.
It’s not okay. Even the FDA, as ineffective as they are, recognizes that it is not appropriate to subject children to the risk of serious and permanent adverse drug reactions unless they are faced with life-threatening infections like anthrax and plague.
But too many doctors either don’t realize that fluoroquinolone adverse-reactions are severe, or they think that they can gauge the appropriateness of the risk of their prescribing behavior better than the FDA, and they prescribe fluoroquinolones off-label. This is absurd, foolish, and dangerous. Off-label prescribing is essentially experimental. It is not “evidence based medicine,” it is “throw it at the wall and see if it sticks” medicine. And everyone whose child was given a fluoroquinolone for treatment of an infection that wasn’t anthrax, the plague, or a complicated urinary tract infection was, in a sense, experimented on. The approved uses for Levaquin/levofloxacin, Cipro/ciprofloxacin, Avelox/moxifloxacin, and the other fluoroquinolone antibiotics in children are limited, but few doctors are paying attention to what the approved indications for fluoroquinolones are, and I doubt that most physicians even know that fluoroquinolones are not approved for use in children for, say, skin infections, or travelers’ diarrhea, or sinus infections, or swimmer’s ear, etc.
It is awful when anyone is prescribed a dangerous drug in a reckless or uncalled-for way, but it’s particularly horrible when it happens to children. Tragically, children are being hurt by negligent, off-label fluoroquinolone prescriptions. It’s not okay. Yet the FDA, and other world-wide regulators of medicines, are not doing anything to stop this practice. If the FDA is going to pretend to regulate the use of pharmaceutical drugs, they should start with curbing the practice of off-label prescribing – especially for pediatric patients. After all, what good are prescribing guidelines if no one pays attention to them?
Fluoroquinolones are too dangerous for anyone who is not facing a life-threatening infection to use. They are certainly too dangerous for use in children. The FDA knows this, yet they are unwilling to do anything to enforce their own guidelines around pediatric fluoroquinolone prescriptions. Tragically, children are being hurt because of doctors who prescribe fluoroquinolones off-label – and the FDA is unwilling to do anything to stop it.
YUP!!!! I was just sitting here trying to make up my mind about posting a comment that could be considered very cynical. Bottom line and behind our backs WE FLOXIES are $$$$ and big $$$$ to the medical community. Has anyone heard of a doctor or organization that has said they will treat a floxie for FREE? In our quest to feel better we undergo numerous kinds of treatments and consume numerous kinds of supplements. All $$$$ in someone’s pockets. I could probably go on and on with example after example but facts are facts. We and our numerous problems are $$$$ in the pockets of the medical community. To our faces we get the bleeding heart sympathy (not always but some of the time) …..BUT….. when our backs are turned they salivate at the prospects of the $$$$ they can make treating us.
The people (drug companies themselves) with the scientific and laboratory capabilities sit on their hands and watch the profits roll in. Profit $$$$ they can use to influence the FDA.
Have you heard of the scientist who goes in on Saturday and Sunday for FREE to try to find solutions to our problems? I submit NO! But they are there all week (being paid well) trying to concoct more drugs that can be as or more lethal than Fluoroquinolones.
Just for the record……….. Did you know that Levaquin is a supped up version of the existing antibiotic Ofloxacin. They added a second Fluoride molecule to it. Maybe to make it just enough different that they could patent it? It made it different alright. It moved Leviquin to the top of the list for being the most toxic or the Fluoroquinolones still allowed to be on the market.
Lisa B……….. If you feel this rant is a bit over the top. Feel free to delete it.
They shouldn’t even be used for complicated uti. That’s insane.
“FLOXED”!!!!!! ……Why??????!!!!!
Zahra, our 8 year old daughter is unfortunately one of the victims of this class of drugs. She was prescribed Norfloxacin 4 weeks ago for a UTI that showed resistant to all other antibiotics and by her third dose could not stand or walk!!! The tendons behind her knees are severely inflamed and not much so far is helping. She has been in a wheelchair since Sept 2, the day before school reopened and has been in so much pain that she has hardly attended school.
Unfortunately , doctors here are clueless as to what needs to be done to reverse this horrific situation. She cannot take anti- inflammatory meds as they cannot be used long term or with this in her system. The pain has been excruciating at times, especially at night after a day of being lifted to do every thing. We are hard at work searching for the formula or hospital that can reverse this.
I have learned since discussing her case with a number of persons internationally that people get hurt by Cipro in particular every day- the problem is that very often the symptoms don’t show immediately. So yes, we know the medical opinion on these drugs, but research the harm they do and then tell me if you would ever take one or give one to your child if the situation were not life or death!
https://floxiehope.com/2016/10/10/children-are-being-hurt-by-fluoroquinolone-antibiotics/