Child Safety Blog

On this blog, we have discussed concerns over the efficacy and safety of cough and cold medications for very young children and babies many times.

Today, the Medicine and Healthcare products Regulatory Agency (MHRA) in the United Kingdom has removed these medications from the shelves. Most of them will be allowed back on the shelves after the addition of a warning label saying that they should not be used on children under 2. From the article:

Sara Coakley, spokesperson for the MHRA, told BBC News it was a precautionary measure and the medicines are not dangerous.

"There's nothing wrong with these medicines, it was the way that they had been given," she said.

There was no need to panic, said Coakley, they would not be on the shelves in the first place if they were inherently dangerous.

The alert concerns 12 active ingredients: brompheniramine, chlorphenamine, dextromethorphan, diphenhydramine, ephedrine, guaifenesin, ipecacuanha, phenylephrine, pholcodine, pseudoephedrine, oxymetazoline, and xylometazoline.

According to Times Online, at least 5 deaths of children under the age of two and more than 100 cases of serious adverse events have been linked to cough and cold medicines in Britain.

The danger occurs when a child is given too much of the cough medicine or has more than one at the same time. Small children are more at risk of overdose because of their smaller body size, said the MHRA.

The MHRA is encouraging parents to give their children simple remedies like honey and lemon.

For more information, see the older discussions linked at the beginning of this post.

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Around 7,000 children per year have to go to the emergency room because of cold medicines.

The study was done by the Centers for Disease Control and Prevention. Points to note:

-two thirds of the cases involved children taking the medicines without proper adult supervision or direction;

-one-quarter of the cases involved parents giving children the proper, recommended dosages;

-this study follows other stories that might raise concern about cold medicines and very young children, such as the FDA warning against such medicines for toddlers, a lawsuit filed by the mother of a boy who died after taking common cold medicines, and a voluntary recall by Tylenol, Dimetapp and others.

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Recently, many have raised questions about the efficacy and safety of common cough medicines for children, many of which include the ingredient dextromethorphan.

But now an easy substitute seems to have been found: honey. Specifically buckwheat honey, which a new study has found to be more significantly more effective than dextromethorphan in curing coughs in young children. The study examined and compared the effects of dextromethorphan, honey and no treatment at all in 105 children. Honey was more effective than no treatment, whereas dextromethorphan was not.

The effective dosages of honey were: half a teaspoon for children aged two to five, a full teaspoon for those aged six to eleven and two teaspoons for the twelve to eighteen age group.

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A month after the FDA change in labeling guidelines for cough and cold medications for children and a voluntary recall of those products, the mother of a boy who died after taking cold medication is filing a lawsuit.

The baby, son of Dimitria Alvarez of Illinois, was four months old. He died after taking Infant Tylenol Cold Decongestant Plus Cough and Walgreen-brand Pediatric Drops-Cough Plus Cold, according to the mother. The commonality between these two drugs is that they contain dextromethorphan, which is found in many cough and cold medications, including many of those recalled.

For more information on the uses of dextromethorphan, see this page from Medline Plus.

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The Food and Drug Administration plans to meet to discuss the efficacy of cough syrup and cold medications for children. This comes on the heels of a voluntary recall of more than a dozen brands of children’s cough and cold medications, including Dimetapp, Robitussin, Tylenol and many others.

The FDA has already ordered a change of label guidelines for the use of such medications on children two or younger. Doctors are pushing for an outright ban, and also for restrictions for children up through age six. No study has been done demonstrating the safety of these medications on children, and quite a few have been done showing that they are no more effective than placebos and that overdosing is a serious problem. Parents, believing cough syrup to be completely mild and harmless, run the risk of giving overdoses to toddlers and very small children.

For more information and commentary:
Why give children placebos?

Doctors discourage use of cough syrup

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On Wednesday, the FDA (Food and Drug Administration) issued a statement saying that children under 2 should not be given over-the-counter cough and cold medicine unless it's because of specific instructions from a healthcare provider.

What is the reason for this public health advisory? The FDA does not say, confining itself to a vague assertion that cough and cold medications may cause "harm" to extremely young children.

However, the Baltimore City Health Department submitted a petition to the federal government asking for tighter regulation of marketing for such drugs on behalf of several Maryland physicians, pointing to studies suggesting that these drugs are neither effective nor safe in children under 2.

The CDC (Centers for Disease Control) also has some important information about the effects of such drugs on very young children. An interview of theirs with Dr. Adam Cohen, who investigated infant deaths to to cold and cough medicines, is a good resource for some general facts on this topic.

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