Split Personality

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Sigh.

WASHINGTON, Oct. 11 — Makers of 14 over-the-counter cough and cold medicines labeled for use in children younger than two said today they are voluntarily pulling their products from store shelves.

The announcement came just a week before a scheduled FDA hearing to examine the safety of pediatric cough and cold remedies. The action does not include products labeled for use in children age two or older.

In a statement Linda A. Suydam, D.P.A., president of the Consumer Healthcare Products Association, said the withdrawal should not be construed as an admission that the products are unsafe.

"It’s important to point out that these medicines are safe and effective when used as directed, and most parents are using them appropriately," she said. The reason for the voluntary withdrawal "is that there have been rare patterns of misuse leading to overdose recently identified, particularly in infants, and safety is our top priority."

My reaction to this announcement is split. Part of me knows that the scientific studies have pretty much debunked the fact that these medications help children. It will be useful to use this to teach patients/parents that viruses are benign and will eventually get better without treatment.

The other side of me is anticipating these conversations with patients/parents. I have now been practicing for thirteen years in a primary care private practice. My patients are my customers and my job was twofold: serving them as patients and serving them as customers. There are often conflicts between these two in a practice of my sort. Some physicians take a "my way or the highway" approach, figuring that they would rather lose the business than to practice anything but the "best" medicine; some do whatever the patients ask, afraid to lose the business; but the majority of doctors have learned the art of compromise.

You learn to live by the Hippocratic oath: "First, do no harm." So when a patient comes in with a cold, insisting on an antibiotic, you can:

Tell them it is a cold and they will get better without treatment. The patient leaves without a prescription.
Give in to their demands for an antibiotic even though it is not appropriate.
Give a prescription for a cough/cold medication and tell them it may help them avoid an antibiotic.

The first approach is good medicine and bad business. The patient is walks away and wonders why they came (not all the time, but fairly often). The second approach is bad medicine and good business. The patient has what they want, but you may have harmed them by giving them a drug they don’t need. The third approach is what I have often used up to now – perhaps not as good of medicine as #1, but certainly better business than #1, and you are not at nearly the risk of harming the patient as in #2.

Now for children that option is gone. Did I give prescriptions for children for cold medications? Yes. If they were over six-months of age, I would treat symptoms. I know that is not the two-year cut-off that others talk about, but being a father of young kids, I never liked to see my kids feel bad, and so would treat them. I try to do the same for my patients that I do for my own kids. Did it help? I am not certain, but it sure as heck made me feel like I was trying.

I know I am now a bad doctor/father in the eyes of some, but I am well aware that the potential for harm with these medications is very slight. It is far riskier to take them for a ride in the car than it is to give them some Triaminic. I have never seen, nor have I heard of actual harm caused to a patient with these medications. I know that there is a risk – especially if mis-used, but in 13 years, I have seen no problems with these medications, whereas I have seen many very rare diseases. I have seen patients die from incredibly rare things, yet I have never seen nor heard of these drugs causing a problem in specific patients.

So I am very mixed in my emotions about this whole announcement. I suppose it is good that we are doing "better science" and that a few kids won’t be harmed by these medications. Yet we continue to be penned in by this idea that medications should have no risk or should be proven effective. There is a huge difference between risk and danger. I think this gets distorted in our ultra-paranoid media culture.

It just gets me tired sometimes.

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Linda Woods

As a pharmacist, I have many parents coming in daily to ask about cold remedies for their children. I personally have never (or rarely) offered most OTC's to parents of children under 2 as they specifically state to "consult pediatrician for children under 2." There is a reason for this, obviously. Most parents don't even know how to calculate correct dosage based on their childrens weight in kilograms, nor can pharmacists safely extrapolate doses for infants or very young children based on doses determined to be safe for older children. It would be pretty much a crap shoot. It's pretty much always a safe thing to encourage hydration (something like Pedialyte) and perhaps some infant Tylenol but I never go much further with infants. I don't feel comfortable giving infants or children under 2 decongestants. I don't even particularly like adults using decongestants. I feel the OTC's were pulled because the government and perhaps even the AMA wants the public to return to "consulting their pediatricians" due to many parents overlooking more serious illnesses and going the cheap route to avoid taking their children to a pediatrician (which is what they should be doing in the first place if basic hydration, analgesics/antipyretics don't do the trick.
Art Fougner, MD

You still have option 3 - Tell mom to fix up a fresh batch of chicken soup! And there's actual literature to back it up. You could recommend vitamin C as well, but the literature sources, save one forme Nobel laureate, seem less firm.
ipanema

after all these years, only now they find out? don't tell me infants are dying because of 'misuse'. i think that's not the only reason behind it. absurd.
Sylvia Brown

I predicted this!
Clay Jones

I agree that these are almost completely safe medications when used appropriately. The issue I have with them is that they don't work. Yet for years, commercial after commercial goes on and on about how effective they are. This is a lie and always has been. I don't really care if they are pulled or not but if they were to stay then the companies that sell them should have to be up front about their lack of efficacy beyond placebo (commencing breath holding).
enrico

Oh, and I agree w/everything you said. Responsible, judicious use of medication to help alleviate symptoms when there's no clear-cut (or less risky) way to "cure" the source is completely logical. It's not quantum physics to understand that a child with nasal congestion due to a cold probably wouldn't sleep as well than if s/he could have some relief with a decongestant (esp. if child uses a pacifier, which s/he would probably want even more when sick).

As I alluded to above--I don't think this is about better science at all.
enrico

The whole recall is super-mega fishy. The FDA slaps "black box" warnings on drugs that it feels the need to, yet other drugs with higher risk profiles go with lesser punishments. Pharma lobbying of the FDA stinks to high heaven and there's no regulation of this. If these OTC remedies were indeed "safe when used as directed," and only with "rare patterns of misuse" (read: "stupid people using said drug stupidly") were problems found, what would motivate a recall? Moreover, why would ALL these manufacturers pull them almost simultaneously?

And a week before the FDA was to review them.

"Fishy" is being kind. There's something rotten going on behind the scenes here.
CAK

So, Dr. Rob, maybe doctors in your position have to start talking like anesthesiologists do when they come to see a patient prior to surgery. Anesthesiologists explain the risks--to me, it is a "disclaimer" approach.

There is a risk/benefit ratio you could talk about, as well.

Parents accept a huge risk whenever they put their kids in an automobile, which they do several times per day, in many cases.

They sign off, accepting the risk for immunization reactions. If you go in with your eyes wide open . . . what is the problem?

My understanding from some of the other news items I've heard and read is that dosage information on the packaging is confusing with respect to these cold meds, and therein lies the biggest risk. Have you heard/read this?

My kiddo's pediatrician (with respect to choices 1., 2., and 3. in your post) explained that a child who has a fever is creating an unfavorable environment for the germs. In essence, the child is mounting his own defense against the organism that is invading. And that is a good thing. "So don't be too eager to bring down the fever unless it is making the child VERY uncomfortable and/or not allowing him/her to sleep," said our Dr. Norton.

That explanation was the voice of reason for me. That same ped, Paul Norton, wrote a bi-monthly column for the Milwaukee Journal/Sentinel on pediatric dilemmas such as this one; and he also sent out a monthly newletter to all his patients, discussing the most common issues and questions from his practice . . . So he was very much into educating his patients' parents so that they could understand and accept such information ahead of the time that they were enmeshed in their kid's illness. (A parent is none too patient nor dispassionate when the kid is sick/uncomfortable, as you well know.)

I, for one, can accept turnabouts--that is, what was once good advice is now updated with better advice (sometimes contrary advice, but better advice). I do not expect the doc always be right. I expect him/her to provide the most up-to-date info, the current wisdom. Das ist allis. Don't let anyone put you in a place (on a pedastal) where you are expected to be perfect--that is passe.