A year ago, I wrote about an effort by the Baltimore Commissioner of Health, Dr. Joshua Sharfstein, to convince the US Food and Drug Administration (FDA) to ban the use of over the counter (OTC) cough medicines for young children. Last October, an FDA advisory panel voted 13 to 9 to recommend that these medicines not be used for children under 6. Unfortunately, it has taken a year for anything substantive to happen.
Better late than never, the Consumer Healthcare Products Association, a trade organization representing OTC drug manufacturers, announced that “the leading manufacturers of these medicines are voluntarily transitioning the labeling on oral OTC pediatric cough and cold medicines to state ‘do not use’ in children under four years of age.” This is a big step forward, because most bottles still say to “consult your pediatrician” before treating kids that age – implying that it is safe, as long as a pediatrician is guiding the dosing.
The American Academy of Pediatrics has been saying for years that these drugs do not work and are unsafe for young children. In fact, the AAP advocates a label saying they should not be given to anyone under the age of 6 as well as a ban on marketing them for that age range. Over 7,000 children a year are seen in emergency rooms for problems related to taking OTC cough and cold medications. The vast majority of them are under the age of 3, so even if pharmaceutical companies do not change their labels to match what pediatricians want, a label suggesting these drugs not be used for children under 4 will help a lot.
Why is this topic so important? Because it shows that just because a medicine works for adults doesn’t mean it works for kids. Too many drugs are marketed to kids without being tested on children, based on the assumption that kids are just small adults. Thankfully, Andrew von Eschenbach, the Commissioner of the FDA, in his own blog, recognizes that this just isn’t so. Hopefully, the future will be full of drugs that are safe to give to children because they are appropriately tested on children, with the same rigor that they are tested on adults. We owe this to our children.
Better late than never, the Consumer Healthcare Products Association, a trade organization representing OTC drug manufacturers, announced that “the leading manufacturers of these medicines are voluntarily transitioning the labeling on oral OTC pediatric cough and cold medicines to state ‘do not use’ in children under four years of age.” This is a big step forward, because most bottles still say to “consult your pediatrician” before treating kids that age – implying that it is safe, as long as a pediatrician is guiding the dosing.
The American Academy of Pediatrics has been saying for years that these drugs do not work and are unsafe for young children. In fact, the AAP advocates a label saying they should not be given to anyone under the age of 6 as well as a ban on marketing them for that age range. Over 7,000 children a year are seen in emergency rooms for problems related to taking OTC cough and cold medications. The vast majority of them are under the age of 3, so even if pharmaceutical companies do not change their labels to match what pediatricians want, a label suggesting these drugs not be used for children under 4 will help a lot.
Why is this topic so important? Because it shows that just because a medicine works for adults doesn’t mean it works for kids. Too many drugs are marketed to kids without being tested on children, based on the assumption that kids are just small adults. Thankfully, Andrew von Eschenbach, the Commissioner of the FDA, in his own blog, recognizes that this just isn’t so. Hopefully, the future will be full of drugs that are safe to give to children because they are appropriately tested on children, with the same rigor that they are tested on adults. We owe this to our children.
5 comments:
You're way ahead of us...Canada still urges "caregivers to consult a healthcare practitioner to assure that their use is safe and appropriate" before using OTC cough and cold medicines on a child under TWO. I was "lucky" that because of my kids' prematurity I didn't give them anything without 5 doctors down our throats (not really, but it felt that way), but I see friends picking them up for their kids without a moment's thought, and with full cooperation of the pharmacies.
Even now that my children are 13, I still have pharmacists and pharmacy techs telling me that they should be on adult dosages, even though the girls weigh about 55-60 pounds each. We definitely need better guidelines up here, or at least better pharmaceutical education.
Let me ask you this, if my two year old is spiking a fever at 101 and there is a history of seizures in my family relating to high fevers in girls, is it NOT ok to give her children tylenol? Obviously, you need to be conscious of the dosage, which we do consult our doctor in such a case, but isn't it more dangerous in this case to let my daughter fight through the fever, knowing that if it gets to high her body might react in a violent way? I don't see the harm in giving her a dose that's suitable for her age and weight in order to drive the fever down.
As for common colds and in my kids' cases, they seem to get through it within a day without OTC drugs. However, when a fever is involved, we have to take measures mentioned above. I realize that all these drugs do is mask the problem at hand. But in the case of a fever, I feel more comfortable giving my kids something to ease the fever a tad and make them feel comfortable.
But in the end, it's all about education and using your gut instinct as a parent. Consulting your doctor and getting other opinions is critical. It's too serious of an issue not to.
Don,
I hope that what I wrote wasn't unclear. I am certainly not against giving OTC drugs to children just because they don't require a prescription. Treating a fever with acetaminophen (Tylenol) or ibuprofen (Motrin)is safe, effective, and appropriate, especially for a child with a history of febrile seizures. My concern is with cough and cold remedies marketed to children, and my concern is that, unlike acetaminophen and ibuprofen, these drugs are NOT effective and their safety is questionable. If your two year old daughter has a high fever, treating that fever with a drug that is safe and that works is certainly sensible. However, if your daughter has a cold, treating it with a drug that does not work and that may cause her serious side effects... well, that may not be so sensible.
Thank you for reading my blog and for your excellent question.
Doc,
Thanks for the reply. I understand where you are coming from. In my uneducated healthcare mind, all those sort of cold meds do is mask the problem. They don't actually get rid of them. It's like putting a bandaid over a cut that needs stitches. It's going to continue to bleed, but maybe not as noticeable.
The key is healthy living up front to avoid being exposed to viruses that cause colds. Then again, that's hard to do when kids are at school, touching things that other kids touch, getting dirty, etc...all the stuff kids do to get colds!
Again, thanks for the reply. Great content on the blog and I look forward to participating in future conversations.
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