Saturday, October 20, 2007

Scariness

I know it is close to Halloween, but there is no point to scaring a mama like this:

"Some of the drugs — which include Wyeth's Dimetapp and Robitussin, Johnson & Johnson's Pediacare and Novartis AG's Triaminic products — have never been tested in children, something flagged as long ago as 1972 by a previous FDA panel."


Ok, first thing...1972 was a long time ago! That essentially means that almost no drug testing of these cold medicines has gone on almost my entire life!!!!

The article says that there have been "just 11 studies of children published over the last half-century. Those studies did not establish that the medicines worked in those cases..." & "For the most part, the results from tests in adults have been extrapolated to determine whether the medicines work in children. " Aaaaahhhhh!!!! (head desk thunk)

Where's the FDA's common sense, people? Ok, ok, I have not actually researched this myself and the article has no footnotes or list of sources for these statements, sooo I could be jumping the gun. Let's just say that if it really is true, then I am not surprised :o.

Really, though, this is terrible. I have bought all of these products at one time or another, usually at the recommendation of my pediatrician (picks head up and thunks down again)

And, as a Grand Finale, here is the scariest part of all .....

"Later Friday, the panel also was to examine whether the dizzying array of medicines that combine multiple ingredients. The FDA wants to know if drug makers should do away with the combo products."

Ok, now try to read it again. And again! Yes, Virginia that is actually how it appears in the article, in all of its fragmented glory. It just about made my head explode. (for all of you sleepy-heads out there, that first one is not a complete sentence, and the fragmenting is so expertly done that at first glance you wonder what you missed. I have no problem with the content, just the sentence structure, ha)
Oh, & by the way, I finally finished that pink & lavendar baby afghan for my friend last week. What a relief! And, yes, Big Fat Kitty thinks it is hers....
Below is a copy of the article, in case the link does not work: (feel free to skip)
FDA Panel: Cold Meds Should Not Be Used for Kids Aged 2 to 6
Friday , October 19, 2007

Cold and cough medicines don't work in children and shouldn't be used in those
younger than 6, federal health advisers recommended Friday. The
over-the-counter medicines should be studied further, even after decades in
which children have received billions of doses a year, the outside experts told
the Food and Drug Administration. The FDA isn't required to follow the advice of
its panels of outside experts but does so most of the time. "The data that we
have now is they don't seem to work," said Sean Hennessy, a University of
Pennsylvania epidemiologist, one of the FDA experts gathered to examine the
medicines sold to treat common cold symptoms. The recommendation applies to
medicines containing one or more of the following ingredients: decongestants,
expectorants, antihistamines and antitussives.

The nonbinding recommendation is likely to lead to a shake up in how the medicines — which have long escaped much scrutiny — are labeled, marketed and used. Just how and how quickly wasn't immediately clear. In two separate votes, the panelists said the medicines shouldn't be used in children younger than 2 or in those younger than 6. A third vote, to recommend against use in children 6 to 11, failed.

Earlier, the panelists voted unanimously to recommend the medicines be studied in children to determine whether they work. That recommendation would require the FDA to undertake a rule-making process to reclassify the medicines, since the
ingredients they include are now generally recognized as safe and effective,
which doesn't require testing. The process could take years, even before any
studies themselves get under way.

Simply relabeling the medicines to state they shouldn't be used in some age groups could be accomplished more quickly, FDA officials said. Indeed, the drug industry could further revise the labels on the medicines to caution against such use. The Thursday-Friday meeting came just a week after the industry pre-emptively moved to eliminate sales of the nonprescription drugs targeted at children under 2.
Pediatricians pushing for greater restrictions told the FDA advisers Thursday that the over-the-counter medicines shouldn't be given to children younger than 6, an age group they called the most vulnerable to any potential ill effects.

But FDA officials and panelists agreed there's no evidence they work in older children, either. Still, panelists held off from recommending against use in older
children. Some said they feared such a prohibition wouldn't eliminate use of the
medicines by parents. "They will administer adult products to their children
because they work for them or feel they work for them," said the panel's patient
and family representative, Amy Celento of Nutley, N.J. The drug industry says
the medicines, used 3.8 billion times a year in treating cold and cough symptoms
in children, do work and are safe. It says that more parent education is needed
to avoid overdoses that in rare cases have been fatal. A group of
pediatricians petitioned the FDA earlier this year seeking action on the
medicines.


An American Academy of Pediatrics official earlier Friday told the
experts the medications should be relabeled to tell parents they don't work in
children under 6 and may be dangerous.
"Why not label these products with
what we actually know?" asked David Bromberg, a Frederick, Md.,
pediatrician.
Some of the drugs — which include Wyeth's Dimetapp and
Robitussin, Johnson & Johnson's Pediacare and Novartis AG's Triaminic
products — have never been tested in children, something flagged as long ago as
1972 by a previous FDA panel.
An FDA review found just 11 studies of children
published over the last half-century. Those studies did not establish that the
medicines worked in those cases, according to the agency.
For the most part,
the results from tests in adults have been extrapolated to determine whether the
medicines work in children. But even that evidence is "modest at best," said
panel chairwoman Dr. Mary Tinetti of Yale University School of Medicine. Indeed,
all but one of the 22 panelists then voted to say that extrapolation is
unacceptable.
The panel also recommended drug makers provide standardized
droppers with their liquid cough and cold medicines. Experts had told the panel
the sometimes hard-to-use dosing devices contribute to parents unwittingly
overdosing their children.
Later Friday, the panel also was to examine
whether the dizzying array of medicines that combine multiple ingredients. The
FDA wants to know if drug makers should do away with the combo products.
One
health expert told the panel that children catch five to eight colds each year.
Those colds don't necessarily require treatment beyond comfort measures that
don't involve drugs, said Patricia Jackson Allen, of the National Association of
Pediatric Nurse Practitioners.


3 comments:

Motherkitty said...

Just as I have always thought. The government has messed up AGAIN. And, our children have been made to suffer all these years all because the FDA (federal dingbat administrators) didn't do its job. Yes, you too are included in this mix. You and your brother were administered these OTC drugs by me, your loving mother, upon the advice of our family physician.

The FDA is required by law to oversee the production and distribution of all medicines that are ingested by Americans as prescribed and recommended by physicians. No wonder there is so much drug resistance, autism, and other serious problems suffered by children going around these days.

Probably for the past 50 years the American public has been fooled by the pharmaceutical industry (out for profits only), the government (out to ensure the pharmaceutical industry makes a lot of money), and Madison Avenue (out to ensure they make lots of money in advertising) so we will believe all their slanted and distorted information and buy, buy, buy at the expense of our children. I admit it -- I'm guilty of being mislead all my adult life. Haven't we all?

So, what's a mother to do when their child has a cold, congestion, headache, runny nose, earache, cough, fever, and malaise? It will be interesting to see physicians' responses to these products being pulled from the shelves. We will probably see more prescribed medicines such as more antibiotics and decongestants, parents will administer adult doses of OTC drugs (out of frustration), or our children will have to suffer in silence.

When I was a kid back in the 1940s, we didn't have all these products. What did our mothers do? They smeared our chests with Vicks Vaporub and dabbed some in our noses. They also had us hang our heads over the sink with a towel over our heads while the hot water ran. Maybe they will even revive the use of mustard plasters.

I can't wait to see how this government agency tries to pull another fast one over on the American public.

I'm going to shut up now.

Sandy said...

I'm glad I NEVER used cold meds on my kids. I did rub Vicks Vaporub on their chests just as my step mother did for me and we used a vapoizer for stuffy noses & heads. Coughs were treated with honey & those little candy like cough drops. Earaches with warm olive oil or smoke blown into the ears.

Still to this day, I use the steam off of my own cup of coffee in the mornings to clear up my sinus headaches in the winter months. Maybe it's time to start using the home remedies of our grandparents time and to let our own immune systems do the jobs they were intended to do and quit relying on drugs so much to alleviate symptoms. It's no wonder we have superbugs that are no longer resistant to our over use of drugs.

Hearing all this come out now, the FDA has been a big disappointment and I'm now wondering what they do up there in their mighty towers. Is any medication really safe? If they aren't protecting our precious babies & young children, how can we be sure the FDA is looking out for anyone else either.

The use of these OTC cold remedies I know have been used by my grandchildren & great grands and luckily they are all seem okay and have suffered no serious consequences. This is a wakeup call that OTC drugs are not to be used indiscriminately...they aren't harmless...that's for sure.

We've all been mislead by believing that the FDA was diligently overseeing all of our medications. This is indeed very scary news...The FDA is a home grown terrorist organization...What else can you call them?

Mama Lamba said...

We are under seige by The Flu as I type this...Sigh.
This topic is a soapbox I shoved under my bed years ago, because I felt that *NO ONE IS LISTENING TO ME*!!! (not you nice folks, lol)It has been 10 years since I gave one of my littles any of these medicines. I noticed way back then, with a 3 year old and a baby, that those things only made the illness *worse* by thickening the secretions and making them harder to expel--leading sometimes to bacterial infections that had to have antibiotics...ARGH!! Finally, I had a great pediatrician that, when I took DD to him for a cough/cold, he told me, "The only thing wrong with this child is that you're medicating her." !! He said never to use that stuff. Of course, when I told friends and family this, they acted as if both I and that quack of a doctor had lost our minds. lol
So, what to do? 1) keep in mind that *most* illness are viral and there 'ain't nothin' that'll cure it"...'cept time.' 2) Fever is our FRIEND! That's the mechanism God gave us to kill germs! So, I never allow a child to take Tylenol or ibuprofen if s/he has any fever--you don't want to suppress God's Medicine...3)VapoRub Rocks! IMO, buy the smallest jar (it loses punch over time) and don't buy generic. Gotta be the real stuff. 4)humidify Child's bedroom--you wanna keep that stuff loose in their sinuses...5) chicken soup really helps 6)nursing mamas should never wean when they get sick--Baby *needs* those antibodies Mama is making, and in all likelihood, Baby's already been exposed 7)croupy coughs respond well (often) to a steamy bathroom 8) warm tea helps--watch that little ones don't burn themselves 9) (this one feels great!) heat up a buckwheat pillow in the microwave (just a bit for tiny folks) and have Sick One lay his head back on it, base of the skull resting on the pillow...
Oh, Gawrsh...I could go on...THANK YOU, Allison, for posting this! Sorry for hijacking the comments, lol.