Health Experiment
NEW YORK (Reuters Health) -
At least 10 infant deaths in
Arizona in 2006 were linked to over-the-counter cough and cold
remedies — underscoring the danger of giving the medications
to children younger than 2, researchers report.
The investigators found that of 21 infants who died
unexpectedly and had autopsy data available, 10 had evidence
that they been given cough or cold medication shortly before
they died.
The findings, published in the journal Pediatrics, do not
prove that the medications caused or contributed to the
infants' deaths, but they add weight to a recent warning from
the Food and Drug Administration (FDA) that parents not give
cough and cold remedies to children younger than 2.
“We strongly recommend that parents not use these
medications,” said Dr. Mary Ellen Rimsza of the University of
Arizona College of Medicine in Tucson, the lead researcher on
the new study.
Cold and cough medications typically contain a combination
of decongestants, antihistamines and cough suppressants — all
of which can have serious side effects in young children,
including increased blood pressure, heart rate disturbance, and
depressed breathing.
While these dangers are now recognized, until now no study
had examined the possible role of cough and cold medications in
unexplained infant deaths.
Rimsza and colleague Susan Newberry base their findings on
data routinely collected by the state of Arizona on child
deaths. In 2006, there were 90 unexpected infant deaths,
including 42 that were attributed to an injury or suffocation.
The researchers focused on the remaining 48 deaths, of which 21
had autopsy data.
Of those 21 cases, the researchers found, toxicology
reports showed evidence that 10 infants had been given cough
and cold medication soon before their deaths.
However, only one death had actually been attributed to
cough and cold medication; “respiratory illness” was listed as
the cause of death in six cases, while sudden infant death
syndrome was blamed in another two.
Whether the medications led to any of these deaths is
unclear, but the bottom line for parents remains the same,
Rimsza told Reuters Health: Don't give the drugs to infants.
There are also concerns about the safety of cold and cough
remedies for older children.
In fact, an expert advisory panel to the FDA has
recommended that parents refrain from giving the medications to
children younger than 6. The FDA is still reviewing the data on
that question.
Rimsza told Reuters Health that as a pediatrician, she
agrees with the stance of the advisory panel. Parents may
assume that over-the-counter means “safe,” she noted, but in
fact, cough and cold medications have never been proven safe
and effective for children of any age.
SOURCE: Pediatrics, August 2008.
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One Response
Jeff
09|Aug|2008 1If you extrapolate the 10 infant deaths associated with cough and cold medications from Arizona’s population of 6 million, to the combined US & Canada population of 337 million, the estimated deaths associated with cough and cold medications are over 500 a year!
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.
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
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