Tag Archives: children

Fluoroquinolone Prescription Guidelines for Children

The ONLY FDA approved uses for fluoroquinolones in children are:

  1. Anthrax
  2. Plague
  3. 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.

 

Children are Being Hurt By Fluoroquinolone Antibiotics

It breaks my heart when I hear about children getting “floxed.” It’s bad enough that fluoroquinolones inflict pain, tendon tears and ruptures, dysglycemia, insomnia, psychiatric problems, autonomic nervous system disturbances, hormonal issues, and more, on adults–it’s horrifying when those things happen to children. Our children, our babies, our innocent and precious kids, are getting hurt by fluoroquinolones too. We try to protect our children–it’s our job to protect them. We trust that when we go to the pediatrician, he or she won’t poison our babies, but, tragically, sometimes pediatricians do, indeed, poison children with fluoroquinolones. Sometimes they prescribe Cipro/ciprofloxacin, Levaquin/levofloxacin, Avelox/moxifloxacin, and Floxin/ofloxacin to children, and sometimes those children suffer devastating consequences from taking those drugs.

It is so incredibly wrong to give children drugs that can cause permanent pain and disability that I’m furious that it happens at all. I’m also furious that there aren’t any consequences for the various parties that allow fluoroquinolones to be prescribed to children. In case it needs to be said, hurting children, and chemically causing pain and disability for young boys and girls, is wrong.

It is well-documented that fluoroquinolones cause permanent lameness in juvenile animals and that they are contraindicated for the pediatric population. A review in U.S. Pharmacist notes that:

“Fluoroquinolones have demonstrated adverse effects on cartilage development in juvenile animals through the inflammation and destruction of weight-bearing joints.  These arthropathies were often irreversible, and their potential occurrence in children limited the use of fluoroquinolones in this population.  In one pediatric study, ciprofloxacin had a 3.3% (9.3% vs. 6.0%) absolute risk increase in musculoskeletal events within 6 weeks of treatment compared with control agents used to treat complicated UTIs or pyelonephritis. Adefurin and colleagues found a 57% increased relative risk of arthropathy in children given ciprofloxacin (21% overall) versus those in a non-fluoroquinolone comparator arm. In contrast to animal models, neither dose nor duration had an effect on the rate or severity of arthropathy.  A 2007 study by Noel and colleagues determined the incidence of musculoskeletal events (primarily arthralgias) to be greater in children treated with levofloxacin compared with nonfluoroquinolone-treated children at 2 months (2.1% vs. 0.9%; P = .04) and 12 months (3.4% vs. 1.8%; P = .03).  These results and the severity of the effects should be weighed heavily when initiation of fluoroquinolones is being contemplated in pediatric patients.”

To summarize, fluoroquinolones can cause irreversible musculoskeletal harm and in doing so, they can put an end to a child’s days of running, jumping, playing soccer, skiing, dancing, etc. Think about that for a second–a drug, an antibiotic no less, can cause permanent damage to the musculoskeletal system of a child. Fluoroquinolones also have serious CNS effects, and can cause psychiatric disturbances as well as loss of memory and concentration. Children, with their developing bodies and minds, should not be subjected to dangerous, disabling drugs that can set back their development and their lives.

Given the documented adverse effects of fluoroquinolones on children, and the black box warning that notes that they can cause disability, the following examples of children being hurt by fluoroquinolones are both infuriating and heartbreaking. Still, I think they should be shared, so as to warn other parents of the dangers of these drugs, and hopefully fewer children will get floxed in the future.

I have paraphrased the stories that I’ve heard, but all of these are true:

  1. A 16 year old boy has Cipro 17 times over the last 7 years. He has various health issues, including a problem with the bones in his feet. The pain in his feet is so bad that he has had to stop school and homeschool on the computer.
  2. A 9 year old took fluoroquinolone ear drops twice as a toddler and suffers with chronic foot and knee pain.
  3. A young woman was floxed 4 1/2 years ago at 16 years old. After about 2 years, she got better, eventually reaching about 90-95% better, only to have a relapse for no apparent reason about a year later (which is where we are now)! She has had MANY devastating side effects, and still cannot work. When she got her first job is when the relapse took place.
  4. A 15 year old girl passed away 6 days after her 10 day Levaquin script.
  5. An 8 year old girl had to quit all sports swimming and gymnastics. She is now going to school but no P.E., and no Dr. Wants to take responsibility for how to help with her pain. It’s been only 2 weeks since taking 3 days worth and then being hospitalized because of the effects.
  6. A 10 year old girl who cannot stand or walk, and no doctors believe her. 
  7. A 16 year old girl took 2 pills of 500 mg of cipro and now has nerve twitching, leg pain, anxiety, and a whole bunch of other symptoms. 

These are kids! They are children and adolescents who are being hurt by fluoroquinolones. They are suffering and there is nothing that doctors can do to relieve their pain. It’s beyond heartbreaking–it’s infuriating–and it needs to stop. The FDA needs to put enforceable restrictions on pediatric fluoroquinolone use. The doctors who prescribe fluoroquinolones to children need to be held accountable when they hurt children with fluoroquinolones (either through Medical Board punishment, or lawsuits). The pharmaceutical companies that make these dangerous drugs need to be punished and they need to compensate their victims. Researchers need to be looking into a cure for fluoroquinolone toxicity. All parties involved need to help these kids to recover, because there really isn’t anything okay about hurting a child.

fluoroquinolone-lawsuit-banner-trulaw

 

flu tox get help you need banner click lisa

Are Dangerous Antibiotics Causing Chronic Illness?

Fearless-Parent_Dangerous-Antibiotics-Causing-Chronic-Illness_Featured3

 

I wrote the following post about fluoroquinolone toxicity for Fearless Parent:

ARE DANGEROUS ANTIBIOTICS CAUSING CHRONIC ILLNESS?

Please check it out and share it.  Thank you!

Fearless Parent is a great organization with lots of interesting articles on their web site, and many interesting podcasts.

I was interviewed on the Fearless Parent Podcast a few weeks ago.  You can get more information about the podcast, and listen to it, HERE.

For those who are parents, or who want to spread the word about the dangers of fluoroquinolones to parents, this post on Hormones Matter is a good one to share too – DON’T LET YOUR BABIES GROW UP TO BE FLOXIES.

Thank you for spreading the word about the dangers of fluoroquinolones!  I HATE that children are getting floxed.  HATE IT.  Perhaps, with awareness, we can keep some kids safe.

 

flu tox get help you need banner click lisa

Fluoroquinolones and Children

Hormones Matter Logo

The post entitled, “DON’T LET YOUR BABIES GROW UP TO BE FLOXIES” can be found on Hormones Matter.

http://www.hormonesmatter.com/fluoroquinolone-antibiotics-child-health-floxie/

Despite the fact that fluoroquinolone antibiotics – Cipro/Ciprofloxacin, Levaquin/Levofloxacin, Avelox/Moxifloxacin and Floxin/Ofloxacin – are contraindicated in the pediatric population because they have been shown to cause lameness and lesions on the cartilage of juvenile animals, they are administered to children all the time.  I have a friend who has a three year-old daughter who has been prescribed Cipro twice – once in the form of ear drops and once in the form of pills.  Luckily, my friend knows how dangerous fluoroquinolones are and she didn’t fill the prescriptions.  Other parents and children aren’t so lucky.  Children are being hurt by fluoroquinolones every day.  It’s a tragedy that needs to stop.  Please share “DON’T LET YOUR BABIES GROW UP TO BE FLOXIES” with any friends who are parents.  No child should go through the horror of fluoroquinolone toxicity.

 

flu tox get help you need banner click lisa