The Food and Drug Administration is about to revise regulations on over-the-counter children's cough syrup. The FDA's review may even lead to the disappearance of the drugs from store shelves, making them available only via prescription.
The trouble, it seems, is twofold. First, the stuff doesn't work. Second, it may cause some unwanted side effects (which makes me wonder if you can call something a "side effect" if it doesn't actually have a primary effect...). Side effects include hallucinations (cool!), seizures (not cool), trouble breathing (very bad), heart problems (uh oh), and death (very not cool and very bad).
In response to an FDA-panel report back in October 2007, drug companies yanked all cough medicines for kids 2 and under off the shelves. The FDA let the companies keep selling the drugs for children older than that, however, despite the fact that the panel had determined that there was no evidence that the medicines actually worked.
The FDA had declined to stop the sale of the drugs, even though averse reactions to cough medicines led to over 7,000 ER visits, two-thirds of which involved children aged 2-5. The panel agreed that the drugs don't do any good for children age 6-11 either, but a majority of the panel members thought that parents "wouldn't have any good alternatives" (translation: It would be bad if drug companies would stop making money from this worthless and sometimes harmful product).
How were the companies able to push these harmful products for so long? It turns out that the drugs were first put on the market before proper drug testing was the norm, and then got grandfathered in. And then, hey, people were buying hundreds of millions of dollars of them a year, so what was the problem?
What's a worried dad (or mom) to do? Try a teaspoon of buckwheat honey (but not in children under 12 months as it may cause botulism in infants).
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2 comments:
As a dad and a doctor, I find this a very scary topic. I used to think that as long as my patient’s or I dosed the children’s cold & cough medications right, then everything would be OK. But when I researched this further, it turns out that children have died from “over dose” of ALL THE MAJOR CHILDRENS COLD AND COUGH MEDICINES even when given the correct dose (http://pediatrics.aappublications.org/cgi/reprint/108/3/e52?maxtoshow=&HITS=10&hits=10&RESULTFORMAT=&fulltext=cough+medications&andorexactfulltext=and&searchid=1&FIRSTINDEX=0&sortspec=relevance&resourcetype=HWCIT).
Here are a few interesting facts:
1. Last October 2008, the drug companies promised the FDA that they would change all their labeling to say “do not use” for children under the age of 2, but I was just in the store last week, and a number of packages still had the old labeling!
2. The FDA reviewed safety and effectiveness data this last fall and its expert panel said that “right now the current cold & cough medications should not be given to children under 6.” Here is a link to the FDA’s minutes, “http://www.fda.gov/ohrms/dockets/ac/07/minutes/2007-4323m1-Final.pdf”, see page 6. The FDA made a public advisory in January 2008 about never using it for children under 2, because the Drug companies are fighting them on the panels ruling to never use cold and cough medications on children 2 to 6. Since these drugs were previously allowed by the FDA, the FDA is forced to go though “due process” before they are willing to make an official public statement about never giving these medications to children 2 to 6.
3. The number of infant deaths attributed to cold and cough medicines is dramatically underreported. New research published in the Journal of the American Academy of Pediatrics demonstrated that there were at least “10 unexpected infant deaths that were associated with cold-medication” in 2006 alone in the state of Arizona. Extrapolated over the US and Canadian population, that would be over 500 deaths a year associated with cold-medication! (http://pediatrics.aappublications.org/cgi/content/abstract/122/2/e318)
The thing that the drug companies don’t want anyone to know is that these medications never underwent the rigorous safety and effectiveness studies modern medications have to go though, they we grandfathered in the early 1970’s because at that time experts felt like they seemed to work, and they seemed safe enough.
Thee is a new company that is going to be selling buckwheat honey in pharmacies. There is a web site that talks about this, and gives lots of research to help parents be better informed about how to help their kids. Check out http://www.honeydontcough.com/
-Daddydoctor
The cough syrup issue is real and many children are dying as a result of it. On may 31, 2008, we lost our precious grandson, Evan, after a second dose of cough medicine was given to him. We had celebrated Evan's 6th birthday the week before he died. If you have lost a loved one that was given cough medicine, please email me. We have to take our angels to Washington and get the cough syrup banned.
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