FDA: OTC Cold & Cough Meds Too Risky For Tots
14 CommentsBy Ed Silverman // January 17th, 2008 // 7:14 am
The agency is expected to make that announcement today, although there’s still no decision on whether these meds are appropriate for older children to continue using, the Associated Press reports. The final word may not come until spring, which is the deadline to notify manufacturers before production starts for next fall’s cold season.
For now, the FDA is issuing a public health advisory on Thursday to warn parents to avoid these drugs for children under age 2 “because serious and potentially life-threatening side effects can occur,” the AP writes.
It’s not the first warning about cold remedies and tots, the AP reminds us. Last October, drugmakers quit selling dozens of versions of these OTC meds that are targeted specifically to babies and toddlers. That same month, an FDA advisory panel voted that the drugs don’t work in small children and shouldn’t be used in preschoolers, either — which is anyone under age 6.
Today’s advisory marks the government’s first ruling on the issue: Don’t give the drugs to children under 2. And it comes now because the FDA is worried that parents haven’t gotten that message despite all the publicity last fall. They may still have infant-targeted drugs at home, or they may buy drugs meant for older children to give to hacking tots instead, says Charles Ganley, FDA’s nonprescription drugs chief.
“We still have a concern,” Ganley tells the AP. “It falls out of people’s consciousness. We’re still in the middle of cold season right now.”
He adds that he is particularly concerned by recent surveys that suggest many parents don’t believe OTC cold remedies could pose a problem, especially if they’ve used them with an older child who seemed to get better.
But the health advisory is a good first step, says Josh Sharfstein, Baltimore’s health commissioner, who petitioned the FDA last year to end use of these nonprescription remedies by children under 6, a move backed by the American Academy of Pediatrics.
The reasoning: There’s no evidence that these oral drugs actually ease cold symptoms in children so young — some studies suggest they do no good at all. And while serious side effects are fairly rare, they do occur. Indeed, the Centers for Disease Control and Prevention last year reported that more than 1,500 babies and toddlers wound up in emergency rooms over a two-year period because of the drugs.
“It’s one thing if you’re curing cancer, but we’re talking about a self-limiting illness,” tells the AP. “If there’s really no evidence of benefit, you don’t want to risk the rare problem. Then you’re left with tragedy that you can’t justify.”
Drugmakers say the meds are used 3.8 billion times a year in treating children’s cough and cold symptoms and are safe for those over 2.
Health groups acknowledge that while low doses of cold medicine don’t usually endanger an individual child, the bigger risk is unintentional overdose. For example, the same decongestants, cough suppressants and antihistamines are in multiple products, so using more than one to address different symptoms — or having multiple caregivers administer doses — can quickly add up. Also, children’s medicines are supposed to be measured with the dropper or measuring cap that comes with each product, not an inaccurate kitchen teaspoon.
Why is this an issue now? Child versions of cold remedies were allowed on the market decades ago, when scientists thought that what worked in adults would automatically work in children. Scientists today know that is not always the case.
So the FDA is asking an even bigger question: Are OTC cold remedies safe and effective for children under 12? The agency’s advisers last fall stopped short of recommending no use by children ages 6 to 11, but they did call for more research to determine what effects the medicines have in youngsters overall.
Separately, an internal FDA working group hasn’t yet reached a consensus about children 2 to 11 years old, but has been given a February deadline to forward recommendations to agency leaders, Ganley said in an interview Wednesday. The goal is a spring announcement.
Source: The Associated Press
nipsey russell
is it just me or are we throwing part of the baby out with the bathwater? ok, yes i get it: small risk associated with unknown, perhaps small benefit. But as i keep hearing, the risk is mostly associated with inadvertent overdosing. Um, so if the problem is that morons cant figure out not to give their children too much meds or overlapping meds, shouldn’t we tackle THAT problem and not tell everyone its bad?
Nathan
Russell,
Amen to that.
Lisa Van S
Nipsey– How do you tackle this problem?
http://www.emedecine.com/ped/topic2786.htm
In the US: Data from the 2004 annual report of the American Association of Poison Control Centers toxic exposures surveillance system (AAPCC-TESS reveal that 48,204 SSRI Exposures (from a total 103,155 antidepressant exposures) occured; 11,680 exposures to SSRI’s occured in children aged 6-19 years, and8187 occured in children younger than 6 years.
Mortality/Morbidity: AAPCC-TESS 2004 data reveal that 8187 exposures resulted in Moderate or Major Morbidity, w/ 103 deaths
Maybe FDA should spend some time focusing on this problem.
nipsey russell
Lisa, i dont get your question. Are you suggesting treating my baby’s cough with paxil or just changing the topic to enhance my point that the FDA should drop the pediacare question in favor of more pressing priorities?
As to “How do you tackle this problem” ….hadnt thought about it, but my initial answer based purely on what you typed (your link is busted) is….mmmm….thinking….
…well it seems that, again, the problem is stupid parents getting their kids in trouble. I hate to visit the sins of the father on the child, so to speak, but lets assume that stupid parents have stupid children (not sure that has been researched, but lets assume as it sounds reasonable). My solution, is to let evolution resolve the problem.
Lisa Van S
My point is that FDA has “Banned” OTC Cough Syrup, But yet they think giving antidepressants and antipsychotics to infants and toddlers are ok….. Why wont they ban psychotropics for those under 2? $$$$$
nipsey russell
because i’d rather have a baby with a cough than a baby with bipolar disorder?
Lisa Van S
Its easy enough to diagnose a cough in a baby, but the more important question is this,….How the hell can you “Diagnose Bipolar” in a baby.
TOdd
Wow, just glad to see Lisa expand your knowledge base. Now full time expert in everything. Thanks for the update on how easy it is to treat kids.
I think I would rather have the actual Nipsy Russell treat my child, but that’s just me. BTW, a doc can still prescribe cough medicine Lisa, you just can’t get it OTC. Can you still get OTC pediatric Risperdal?
DUDE - GREAT SCREEN NAME! love it, love it, love it.
Lisa Van S
Todd,
Can you tell the difference between a “Normal Baby” and a “Bipolar Baby”. I know I cant…
Im all for banning antipsychotics in babies,.. How about you.
nipsey russell
i have no formal medical training, TOdd, but I’ll do anything for a buck. E-mail me your child and I’m happy to treat the little bugger!
@ LVS - i’m sure we all watched frontline’s report recently on over-medicated children and certainly want to avoid giving unneeded powerful medicines to children, but some of those kids definitely needed a little somethin-somethin as they were NOT ok
Brian
Key difference is that FDA is banning the public from use of cough medicine because a few of the lowest common denominator tend to give their kids to much.. While, I agree that very young children probably need better parenting, I can imagine incompetent parents hounding doctors for drugs for their mentally disturbed children. Better parents could find a way out of this mess w/o drugs but the final call comes from the Doctor who writes the scrips..
Nathan
As I posted a few months back, I wonder about the unintended consequences of taking about one of the only medications available to babies.
It used to be common to give kids a shot of tsp to treat a cold. Are we going to see drunken babies show up at the hospital?
How many overdoses are now going to be caused by parents cutting a adolescent’s pill (or dose) in half just to have SOMETHING that they can do to help their kid breath better?
How many parents are going to start resorting to completely untested and unproven “herbal” remedies to alleviate their kid’s suffering?
As I’m sure all of you know, one of the hardest things to do as a parent is to watch your child suffer and not be able to DO anything about it. Parents WILL end up doing something to help their baby’s cough/cold. The FDA is gambling that the “something” parents choose to do is safer than the drugs we currently give them. I’m not so sure it’s a safe gamble.
Lisa Van S
Nipsey,
Did not watch frontline, I take pride in having good blood pressure. You say the kids needed a little something, It appears to me that they had a whole lot of something.
and Brian, So Glad You Brought up Docs!!!
With that said, Im providing a link to NJ Medicaid Tables, here you will see what NJ Tax Payers get for their hard earned money; age of the child and the drug they recieve, and the Doc who prescribes. Abilify, Risperdal and Zyprexa are not included, I believe that in itself, needs a seperate page. I will provide a link when completed
http://www.psychdrugdangers.com/notapprovedpediatric.html
Lisa Van S
Nathan,
We have had our differences, but here you are 100% correct!! I couldnt agree more,.. Well said.