FDA rethinking use of cold medicines in young children

I’m a few days behind on this, but FDA officials are recommending that labeling for cold and cough medicines be changed under pressure that the medicines are neither safe nor effective in small children (less than 2-6 years of age, depending on the medicine). The medicine label would be stripped of any recommendations for parents to “consult a physician” before giving them to a small child, and may include a new label saying they are not recommended for use in children under 2. There are also recommendations to standardize the measuring system for children’s medicines to avoid confusion over correct dosage, and apparently some officials are even considering an outright ban on all infant cold and cough medicines.

The reviewers wrote that there is little evidence that these medicines are effective in young children, and there are increasing fears that they may be dangerous. From 1969 to 2006, at least 54 children died after taking decongestants, and 69 died after taking antihistamines, the report said. And it added that since adverse drug reactions are reported voluntarily and fitfully, the numbers were likely to significantly understate the medicines’ true toll.

Ok, let me first say that I think it’s really tragic any time a child dies (or any time someone dies before reaching an old age), but these numbers don’t seem to suggest some sort of major health crisis. Yes its unfortunate that children died after taking the drugs, but given the number of children that probably took the drug over that 30+ year period, 123 children is not that many. For instance, consider the backyard swimming pool – around 2000 kids are injured each year, and 300 die each YEAR. Assuming that number has been pretty standard over the past several decades (which may or may not be true), in the 37 year period that 123 children died due to cold medicines 11,100 died due to swimming pool related accidents. Are we banning swimming pools? No, because we leave it up to parents to take responsibility for their children – and given how many trips are made each summer to the local or backyard pool compared to the number of kids injured, they’re doing a pretty good job.

So why should cold medicines be any different? I don’t have any kids, but reading this FDA recommendation for a medicine-ban makes me think that they don’t either. If your kid is sick, you want to make them feel better, and you don’t always have the time to go to the doctor and sit in an office waiting for the physician to tell you that your child’s cold is viral so all you can do is treat the symptoms with an over-the-counter drug (as opposed to the more rare bacterial infection which might require antibiotics). And you certainly don’t want to go to the doctor and have them tell you there is nothing you can do for your crying, congested, coughing child since the FDA banned all cold and cough medicines. As far as standardizing the droppers/cups/etc – I have no problem with that, since it will likely make it easier for parents to figure out the correct dose and decrease the chances of an accidental overdose. I’m just afraid that any ban on these kids products will leave parents trying to use adult products on their children, and then there will be serious problems since they’ll have no idea what amount would be safe in kids. People need more information (how about more research into “safe” doses for kids?), not a regulatory agency that thinks parents will never know how to act in the best interests of their child. Personally I think it’s a bit ridiculous that we’re wasting time debating medicines that people find useful and that rarely cause a serious adverse effect, when there are other things that kill far more children each year (e.g. pediatric cancer). It’s not that I think its ok that young children die because of cold and cough medicines, but I think we have to be realistic about the fact that we live in a world with limited resources, and those resources should be targeted at areas where they will have the greatest impact.


CNN – FDA: Stop giving cold, cough meds to toddlers

NY Times – Ban Sought on Cold Medicine for Very Young


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