Study Reinforces Risks of Cough and Cold Medicines in Infants and Young Children
August 9, 2008 by Pauline M. Campos | one question or comment
According to a recent Yahoo news story, at least 10 infant deaths involving the use of cough and cold medications were reported in
Researchers from the University of Arizona College of Medicine in
There is no proof that the ingestion of the medications caused the deaths, but it certainly does add weight to the Food and Drug Administration’s (FDA’s) warning to parents to avoid medicating children under 2 years of age with cough or cold remedies.
Arizona researchers used data from The Arizona Child Fatality Review Program that reviews the circumstances of every child’s death in the state each year. Data on all infants who died unexpectedly and had autopsy and postmortem toxicologic studies were reviewed for the purpose of the study.
Toxicology reports showed that 10 infants had received cough and cold medications containing the decongestant pseudoephedrine and the cough suppressant dextromethorphan. Decongestants and cough suppressants have been shown to have serious side effects in children, including depressed breathing and increased blood pressure.
It is important to note that the American Academy of Pediatrics and the American College of Chest Physicians do not support the use of dextromethorphan in infants and young children due to risk for serious reactions associated with the drug. The drug is commonly sold under the brand names: Benylin, Deslyn, Robutussin cough Calmers, and Vicks 44 cough Medicine.
Researchers say that their findings support the FDA’s recommendation to avoid giving cough and cold medications to infants and young children, and sadly show that parents are not following the warning found on the packaging that clearly instructs parents to “consult a physician” prior to use.
Also in the August issue of Pediatrics was survey data showing that 1 in 10 US children uses a cough and cold medication in a given week. Sadly, the highest use was among 2 to 5 year olds, followed by children under 2 years of age—despite concerns over the risk of using cough and cold medication in these age groups.
The Science Daily reported that federal health advisors, testifying before the FDA, stated that children younger than six years should not be given these medications, or at the very least that the medications not be sold over-the-counter.
So how do you keep your child safe and possibly provide some relief from colds at the same time? baby gooroo reported the results of a study published in the Archives of Pediatrics and Adolescent Medicine in which one tablespoon of buckwheat honey provided the greatest amount of relief from nighttime coughs in children ages one and older, when compared to no treatment or treatment with dextromethorphan.
Also, parents should be aware that it commonly takes about two weeks for children to recover from a cough or cold. So perhaps the best advice is “just say no” to medications and “just say yes” to tissues.
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&andorexactf ulltext=and&searchid=1&FIRSTINDEX=0&sortspec=relevance&resourcetype=HW CIT).
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.pd f”, 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.
Interestingly, some researchers from Penn State have shown that Buckwheat honey is better then the OTC drugs for children’s cough. 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