medicine prescribed to my daughter!

[kaeyreed]

I took my daughter to the doctor today because she has a problem with recurring UTI's. The doctor stated during our consultation that he would like to prescribe Cipro for my daughter because it was the best medication to treat UTI's but he couldn't because she was under 18. I came home and went through our medicine cabinet and she had been prescribed Cipro by the same office months before. She is 15 years old. I went to the Cipro website and it stated in the warnings section that Cipro has not been determined to be safe for people under the age of 18. It caused juvenile arthropathy in the animals tested. Now I am furious. How can they prescribe this and then tell me at a later appointment that it's not safe and they can't use it. Aren't there rules that these doctors have to go by, I don't want this type of thing to happen to another? Just looking for some information. This shouldn't happen! How do I know that her taking this before the age of 18 won't cause problems for her down the road? She's already had three major surgeries, she doesn't need anymore problems. I am not happy! Shouldn't the pharmacy have known not to fill this prescription for a minor?

 

[ellencee]

kaeyreed
I believe I am correct in stating that this information on Cipro is somewhat new, and I'm not aware of any outbreak of any problems with juveniles that received Cipro before this information came out. The information did not say it has been found to be harmful in human juveniles, only in rats, or mice, and you know how they do those tests--they give them enough to kill a horse and see what happens. So, my suggestion is not to worry about it at all.
As for the recurrent UTIs, you may want to add some citrus fruits and yogurts to her diet, or increase the amount thereof (provided there are no allergies or medication interactions of which you are aware), and stop any and all bubble baths, or baths at all, and simply shower; omit the wonderful, good smelling bath gels,etc. and use good old Dial soap. Also, get rid of any undies that aren't pure 100%, undyed, cotton, or at least an undyed cotton crotch area; get rid of all thong undies, and all pantyhose; use a nice self-tanning product instead. Make sure all athletic or sports clothing has a 'wicking' action to pull moisture away from the body.
Good luck and God bless her--UTI's are a pain I wish on no one!

 

[kaeyreed]

Thank you very much. This puts my mind at rest. I was scared to death yesterday. And thanks for the advice on the UTI's. My daughter has been through a lot and everything that will help her I appreciate greatly.

 

[drugintel]

Off-label use of drugs

I would like to differ with the previous respondent on the question whether your daughter should be prescribed Cipro or not. The notice that Cipro is not approved for those less than 18 years would not be new information. Rather, it is FDA policy to require proof of safety (and efficacy) in a pediatric population before a drug is allowed to be used for them.

This proof of safety is not obtained "in mice or rats or something". It's performed by carefully monitoring experimental use in people who have the diseases being treated (called Phase III clinical trials).

The physician can prescribe a medicine for use that is different from the approved use, in any number of ways: taking for a different disease, in combination with other medicines, for younger patients, at higher doses, etc. That is a matter of medical judgement. It's called "off-label use". Often off-label use is just exercising common sense, and it's necessary to allow a physician this liberty for her to be able to work effectively. Physicians will be careful when doing so, however, because it shifts more of the accountability from the pharmaceutical company and onto the doctor, if something goes wrong.

Choosing an alternate medication that has been found safe for your daughter is the prudent move; but if there is none, then to spend a little extra time weighing the risk/benefit in using Cipro off-label.

Use of drugs in pediatric populations is currently a controversial point. Pharmaceutical companies will tend to avoid seeking approval, because pediatric clinical trials are expensive, and potentially risky - they can be sued if there is developmental damage to a child in a clinical trial. But FDA is dissatisfied that many important drugs are not approved for pediatric use - Cipro, for example. So now FDA is attempting to oblige pharmaceutical companies to seek pediatric approval.

As a consumer, I recommend doing exactly as you are doing: when your doctor prescribes something, research it. It's hard for a doc to keep up with all the info and fine print. If your doc makes what appears to be an error, mention it. The reality is that docs make errors, like all of us, and they are under pressure to work faster in an environment that is growing exponentially more complex.

It's much better to research the issue before the treatment and avoid errors, than for errors to be made and then get involved in lawsuits.

 

[David.v.Goliath]

Excelent post.....drugintel.. i am also very versed in "off label" use of medical devices. I was used as an human guinia pig by a medical device company and a surgeon and left totally disabled. The medical device company violated their own protocall and PMA approvel and particapated and coordinated my care and treatment pre-op.........intra-op..and post-op. This was all done without my informed consent. My case is resting in the hands of the high court in the state in which i live. I also have the first informed consent case against a product manufacture in the history of my state court system. The surgeon has also testified at deposistion that the manufacture promoted their device to him in this off label use without any additional warnings. 5 years in court so far and the end is in sight with the appeals decission comming shortly after oral arguements in just 2 weeks! I can also say that the manufactures approved labeling can be used against the doctor to apply the standard of care now in court. Where prior cases have required specific expert testimoney where only doctors could testify to the standard of care. things are looking better for malpractice patients nowdays.