On cold medicines and the FDA

So, being that it’s October (Again? Didn’t we do this like a year ago?) my Dear Son has a cough. And, as with most children, the cough is worst overnight and into the early morning, which makes for less than restful night for him. So, like countless parents on countless nights, I give him cough/sniffle medicine to enable him to breathe and possibly sleep.

Having the annual head-chest cold season start off, got me thinking about something I read the other day. Recently, the FDA decided to review the use of over the counter cold medicines in children. Go read the link quick and come back, okay. If it’s bad, I copied it at the bottom of the post, so scroll down. Go on now. Shoo.

*files nails and contemplates navel*

You back? Good.

Now, here’s why I think this is a mistake. The FDA is just covering its big old governmental tushie- those medicines have been used for decades and every parent knows that they work. They might not work as well as we wish them to, but they do work- and that little advantage that the medicines give in helping kids to sleep and therefore get well faster can make the difference between missing one or two days of school and missing a solid week.

I am not one for giving medicine to kids at the drop of the hat- each of my kids have only ever had antibiotics once. Dear Daughter got them for an ear infection caught from a kid who had chronic ear infections, so it was a hearty little sucker. Dear Son got them when he was hospitalized with an infection in his neck- that was some weird fluke thing that scared the bejesus out of the pediatrician, but actually didn’t put Dear Son out that much. Still, it is good to have the option to give a decongestant or antihistamine along with the steam treatments and the honey and the herbals and the Vapor Rub in the middle of the night while my son’s cough sounds like the barking of a seal and his eyes are barely open but never seem to close long enough to sleep before another cough wakes him up again.

The reasons given for the FDA to start telling parents to stop using medicines that they know and trust are (1) that they are not tested in children and (2) that there have been deaths (115 in 37 years- which yes, any death that can be prevented is tragic, but considering the frequency of use, that number is extremely low). But, studies can be done without removing these very helpful products from the market and most of the deaths can be attributed to accidental overdose and misuse. In fact, studies should be done, since I’m sure that many parents will not give up the use of these products (I’m not planning to). The fact that new packaging will not have dosing guidelines is meant to cover the FDA and the drug maker’s legal liability, but in practice, it could lead to more accidental overdosing as parents try to remember what the old dosing structure was or do the math trying to figure out an acceptable dose using the guidelines for older children.

Thing is, the implied reason for removing the guidelines (aside from covering their butts legally) is because they think that parents are too stupid/ignorant to manage giving the medicines to children that small, so they are taking the option away from them. But, if we are uneducated about the drugs, then where are the outreach educational programs funded by the drug makers and/or the government? There’s plenty of money to advertize Viagra, why aren’t there pamphlets going out to parents about how to follow package directions effectively? Why aren’t there weigh-ins a couple of times a year where parents can take their kids to be weighed and where there are doctors or nurses or pharmacists available to talk to about dosing the way there are seatbelt/car safety seat check programs around the country? In fact, the same seatbelt/car safety seat check programs would be the perfect place for such weigh-ins, since the weight of a child is a factor in which type of seat a child should be using as well as how much cough medicine they need at 3 a.m.

And, where are the directions in Spanish? There are bilingual (and trilingual, etc.) directions about how to use appliances and program our TV remotes, but there are only English directions on how to give a child medicine? Okay maybe there are bilingual directions out there in other parts of the country, but I live in New Jersey, just outside of Trenton- we’ve got Spanish speakers here, we really do. What we don’t have is bilingual directions. And, if bilingual directions can’t be done, why not a set of universal symbols? There is a set of them used by the clothing industry to make sure that you don’t shrink your cashmere sweater or bleach all the color out of your red polka dot dress, but nothing of the kind in use here for children’s medicines!

So, yeah, I don’t like this move by the FDA- it’s political and legal Gerry-rigging in order to look like they are trying to save kids lives, but really, it will increase the chances of overdoses and increase the amount of illness suffered by kids, thereby increasing the amount of stress on parents and families.


I include the text of the links because the news sites are always removing stories when they get old and the link will eventually break. Included for reference only, no copyright infringement intended.

FDA urged to pull children’s cough medicine
Friday, October 03, 2008

Doctors urged federal regulators to seek removal of children’s cough and cold medicines from store shelves until the products are found safe and effective.

The Food and Drug Administration should take action to stop side effects and deaths from the nonprescription remedies until companies produce studies on their use in children, pediatricians led by Baltimore Health Commissioner Joshua Sharfstein told agency officials yesterday. If the agency lacks the power to recall the medicines, companies should at least stop promoting them, the doctors said.

Outside advisers to the FDA recommended last October that the over-the-counter cough and cold drugs shouldn’t be given to children under age 6 and said there wasn’t any evidence they worked in those up to age 12. Companies voluntarily withdrew infant formulations last year.

Doctors said the FDA has been slow to follow through on promised new guidelines for use of the remedies in older kids.

“It is time for them to be re-evaluated,” Michael Shannon, a professor at Harvard Medical School, told FDA officials at a meeting in Beltsville, Md. “If their risk-benefit ratio proves to be unfavorable, as I think will be the finding, then their use in children can’t continue.”

The FDA began reviewing the safety of over-the-counter medicines such as Johnson & Johnson’s PediaCare and Wyeth’s Dimetapp in 2006. The agency received 54 reports of children’s deaths linked to decongestants and 69 associated with antihistamines from 1969 to 2006, involving prescription and over-the-counter drugs.

The products contain ingredients that have been classified by the agency as “generally recognized as safe and effective” since the 1970s, so new mandatory restrictions would require a “cumbersome” rule-making process, said John Jenkins, director of the FDA’s Office of New Drugs. The agency is seeking comment at today’s meeting about what studies are needed and whether the products should continue to be available over the counter.

The Consumer Healthcare Products Association, a Washington trade group that represents makers of nonprescription drugs, said most side effects are caused by accidental overdose and misuse, which can be reduced with better packaging and education. Recalling these products from the market isn’t necessary and may lead to more overdoses on adult-strength formulas, company representatives told FDA officials.

“If pediatric cough and cold products are no longer available over the counter, parents may turn to other alternatives that may result in dangerous consequences for our children,” said Linda Suydam, president of the industry trade group.

The group plans to spend more than $6 million during the rest of this year educating consumers and doctors about its products, including new public-service announcements on radio and television and information on WebMD’s website.

Examples of care instructions:


2 thoughts on “On cold medicines and the FDA

  1. Paul says:

    Surprised your post got no comments after all the trouble you went to (by the way that news link is still good right now).

    I hope your sons cough is better. Something my family used when I was a kid which may be exempt (I’m not in the US so may not know) are homeopathic remedies. Of course this is a whole other area, but I thought it might be worthwhile for me to just mention it if this is bothering you.

  2. Ginny says:

    Thanks for your comment and yes, my son is doing fine now. We do use some homeopathic remedies- humidity, honey, teas with lemon, some store bought herbal mixtures, chest rub (Vicks), zinc lozenges, etc. However some days the kids need something stronger so that they are not coughing so much that they can’t think in school. I wish I had the ability to just keep them home until the coughs ran their courses, but they’d miss weeks of school with how such things seem to hang on around here. Most of the children they go to school with hack and cough their way through the winter months since few of them have the control not to cough on each other and it just goes round and round the classes.

    What really bothers me most about the changes is the fact that it basically removes an option for parents instead of educating them about how to use it.

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