Pediatric Cold and Cough Medicines: First Do No Harm
Update 10/19/2007: With today's news about the recommendation to expand the withdrawal of pediatric cold and cough medicines, we asked Dr. Baum to update his comments below. Here's what he said:
The health and safety of children is our primary focus at Safety4Kids. So when medicine for children is withdrawn from the shelves, we share the concern of parents everywhere. We turn to our own Dr. Carl Baum for his thoughts.
Here's what he has to say:
The Consumer Healthcare Products Association (CHPA) announced on October 11th a voluntary withdrawal of over-the-counter (OTC) cough and cold medicines for children under two "out of an abundance of caution." (http://otcsafety.org/)
The industry has acknowledged that infants under the age of two are most vulnerable to misuse of these medicines. While I applaud the industry's voluntary action in the absence of a mandatory recall, I would question the general claim on the website, above, that "kids' OTC cough and cold medicines are both safe and effective when used correctly..." Apparently the industry would have us continue to dispense these drugs to older kids.
Even if you gloss over the safety issues--and I see children over the age of two in our Pediatric Emergency Department who overdose on these drugs and occasionally have significant side effects--how effective are cough and cold medicines?
As the Latin saying goes, primum non nocere, or "first do no harm." We are often willing to accept some risk in medicine, but the hope is that the intervention will also bring some benefit. If you look at studies of OTC drugs and upper respiratory tract infections in children, however, there is little convincing evidence for the effectiveness of most OTC components: antitussives (allegedly for cough), expectorants and mucolytics (to thin mucous), as well as antihistamines and decongestants (to dry secretions and open up passageways).
But we can't place all the blame on the multi-billion dollar OTC industry. We pediatricians are often responsible for recommending these drugs as we cave to parental pressure to "do something" for symptoms of upper respiratory infections. And remember, these infections are invariably viral processes that run their course no matter what we do. What's the alternative? Salt-water drops in the nose can help to loosen mucous. And a little education goes a long way.
(c) Nolte Lourens. Image from BigStockPhoto.com
Technorati Tags: pediatrics, cold, cough, medicine, FDA, recall
"To date, the problem has been that pediatric dosing for these drugs was extrapolated, sometimes erroneously, from adult data. Finally, everyone is starting to understand the expression, "children are not little adults" (although I prefer "adults are not big children").
The overarching question remains the same, however: are these drugs safe AND effective in children of any age? For the most part, we don't have the data. Are these drugs safer in a 6-year-old than in a 2-year-old? Maybe. Are the drugs more effective in a 6-year-old than in a 2-year-old? Maybe. Maybe not."
The health and safety of children is our primary focus at Safety4Kids. So when medicine for children is withdrawn from the shelves, we share the concern of parents everywhere. We turn to our own Dr. Carl Baum for his thoughts.
Here's what he has to say:
The Consumer Healthcare Products Association (CHPA) announced on October 11th a voluntary withdrawal of over-the-counter (OTC) cough and cold medicines for children under two "out of an abundance of caution." (http://otcsafety.org/)The industry has acknowledged that infants under the age of two are most vulnerable to misuse of these medicines. While I applaud the industry's voluntary action in the absence of a mandatory recall, I would question the general claim on the website, above, that "kids' OTC cough and cold medicines are both safe and effective when used correctly..." Apparently the industry would have us continue to dispense these drugs to older kids.
Even if you gloss over the safety issues--and I see children over the age of two in our Pediatric Emergency Department who overdose on these drugs and occasionally have significant side effects--how effective are cough and cold medicines?
As the Latin saying goes, primum non nocere, or "first do no harm." We are often willing to accept some risk in medicine, but the hope is that the intervention will also bring some benefit. If you look at studies of OTC drugs and upper respiratory tract infections in children, however, there is little convincing evidence for the effectiveness of most OTC components: antitussives (allegedly for cough), expectorants and mucolytics (to thin mucous), as well as antihistamines and decongestants (to dry secretions and open up passageways).
But we can't place all the blame on the multi-billion dollar OTC industry. We pediatricians are often responsible for recommending these drugs as we cave to parental pressure to "do something" for symptoms of upper respiratory infections. And remember, these infections are invariably viral processes that run their course no matter what we do. What's the alternative? Salt-water drops in the nose can help to loosen mucous. And a little education goes a long way.
(c) Nolte Lourens. Image from BigStockPhoto.com
Technorati Tags: pediatrics, cold, cough, medicine, FDA, recall
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