FDA: Cold Medicine Too Risky For Tots

Side Effects Too Dangerous For Children Under 2; No Final Word On Safety For Older Kids

(CBS/AP)  Parents should not give sniffling babies and toddlers over-the-counter cough and cold medicines - they're too risky for tots so small, the U.S. government will declare Thursday.

The Food and Drug Administration still hasn't decided if the remedies are appropriate for older children to continue using, officials told The Associated Press.

Expect a decision on that by spring, the deadline necessary to notify manufacturers before they begin production 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."

This is not the first warning about cold remedies and tots: Drug companies last October quit selling dozens of versions targeted specifically to babies and toddlers, CBS News reports.

In that same month, the FDA's own scientific advisers voted that the drugs don't even work in small children and shouldn't be used in preschoolers, either - anyone under age 6.

Thursday'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, said Dr. Charles Ganley, FDA's nonprescription drugs chief.

"We still have a concern," Ganley said. "It falls out of people's consciousness. We're still in the middle of cold season right now."

Ganley said 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.

Thursday's move is a good first step, said Dr. Joshua 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 reason: 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," said Sharfstein. "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."

The drug industry says these medicines are used 3.8 billion times a year in treating children's cough and cold symptoms and are safe for those over 2.

Last October, CBS News correspondent Wyatt Andrews reported that the cold and cough medicine industry admitted that 92 deaths were connected to combination cold medicines - but claimed 79 of them were due to misuse or overdose.

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.

[famulla-2009]

FDA: Cold Medicine Too Risky For Tots
Side Effects Too Dangerous For Children Under 2; No Final Word On Safety For Older Kids
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[erasmus6]

"Never put anything petroleum based in your nose. It can get into your lungs and cause respiratory problems." posted by Emma915


My mother-in-law died of lung cancer. Maybe it wasn''t from smoking, maybe it was all the vaseline she used to shove up her nose!

Some of the stuff that people do make me cringe.

[emma915]

Never put anything petroleum based in your nose. It can get into your lungs and cause respiratory problems.

[erasmus6]

I never gave my kids anything except plain tylenol for a fever unless I absolutely had to. And I never take anything for a cold. Years ago I took something and it caused major problems with my ears.

People have gotten so they can''t tolerate anything, they immediately have to run out and get something to fix it. The problem is that all this c-r-a-p isn''t good for you!



"But all drugs carry risks - and to take them off the shelves because a small number of parents did not follow directions and/or the kids had issues with the drug means we should pull all OTC drugs and go to our doctor for every little ache and pain!" posted by sunsetmom3


There is no need to be running to the doctor for every ache and pain.

[erasmus6]

"As for the coughing, rub the bottoms of their feet with Vicks VapoRub and put a pair of socks on them." posted by Emma915


Just make sure that it is only on the feet. In fact I would check on that too.There was a little boy who died from having it rubbed on his chest.

When I was little my mother used to rub it on my chest and put it in my nose! Awhile back I went with my mother, who is 82, to the doctor and she told him that she had been using vicks vapor rub in her nose and I thought he was going to have a heart attack. He told her that she should never put it in her nose. The thing is, there are many people out there that do!

[sunsetmom3]

I have three kids and have, on occasion, given them OTC cold meds - following instructions on the label carefully. It helped relieve my kids'' symptoms and allowed them to sleep and not be so miserable. But all drugs carry risks - and to take them off the shelves because a small number of parents did not follow directions and/or the kids had issues with the drug means we should pull all OTC drugs and go to our doctor for every little ache and pain! If adults misread for their kids OTC, they''ll probably misread for their own OTC. The government has to make every effort to protect us from ourselves! Long live the Nanny State!

[emma915]

If you''ve ever had a child go into an anaphylactic siezure due to a penicillin allergy, you''d opt for safer options in child medications. As for the coughing, rub the bottoms of their feet with Vicks VapoRub and put a pair of socks on them. Better safe than sorry.

[mkbjon]

I don''t mean to sound callous, but some children are GOING to die--if for no other reason, by being unfortunate enough to be born to stupid, violent, or inattentive parents. Pulling medications from the shelves is not going to make those parents one iota smarter, gentler, or more vigilant. It''s just Darwinism at work.

[aheadofcrowd]

The problem with almost all medicines and all prescription pills is that they try to suppress normal body functions, "symptoms", when instead they should be working to handle causes. The aim to suppress symptoms while never addressing the cause is one of the biggest mistakes in medical philosophy and is very dangerous to do. It''s also about as effective as having your car''s low oil light turn on and putting a bandaid over it to hide it out of sight.


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[rf35]

This is why people should be required to get a license to reproduce. The stupidity of a few causes all to suffer. Even if every child cited had been given the proper dose and just had a bad reaction, that is still too small a number to justify pulling these from the shelves. Now, all the parents will be running to the doctor''s office to get a prescription for their kids which is probably more dangerous than the OTC medicines. alexma50085 hit the nail on the head, as did kristins126. I''d bet this will come back to bite the FDA in the rear in a few years.

[kristins126]

This is completely ridiculous. I gave OTC cold medicines to my daughter when she was an infant and toddler, of course with my pediatrician''s approval. And they DO help! They are the only way she could get some sleep to fight off the cold. It''s utterly ridiculous that because some parents are too ignorant or lazy to actually read labels and dosage instructions, or talk to a doctor or pharmacist, all kids have to suffer. The vast majority of kids who have had problems with these medicines were due to overdose. Pulling the meds from the shelves is not going to solve this--all it will do is make some parents reach for the medicines targeted for older kids or even adults and guess at what the dose might be for a toddler, which will probably result in *more* overdoses, not less.

I''m in total agreement with the poster below who said that more kids die in car crashes than from these drugs, but we still allow kids to ride in cars. Better watch out though--next thing we know, that will be illegal.

[kristins126]

This is completely ridiculous. I gave OTC cold medicines to my daughter when she was an infant and toddler, of course with my pediatrician''s approval. And they DO help! They are the only way she could get some sleep to fight off the cold. It''s utterly ridiculous that because some parents are too ignorant or lazy to actually read labels and dosage instructions, or talk to a doctor or pharmacist, all kids have to suffer. The vast majority of kids who have had problems with these medicines were due to overdose. Pulling the meds from the shelves is not going to solve this--all it will do is make some parents reach for the medicines targeted for older kids or even adults and guess at what the dose might be for a toddler, which will probably result in *more* overdoses, not less.

I''m in total agreement with the poster below who said that more kids die in car crashes than from these drugs, but we still allow kids to ride in cars. Better watch out though--next thing we know, that will be illegal.

[alexma50085]

400 people in the U.S. die from penicillin every year and we don''t stop people from taking it. Why?? Because the benefits out weight the risks. Same with the cold medicine. How many children are helped compared to how many children die? That''s the question that should be asked.

[apdepetris]

Well, I think you have two things going on here. The first is people who are giving their kids more than the proper dosage as well as giving more than on OTC that has some of the same ingredients (therefore giving them double doses of say a decongestant). The second are kids that actually have a reaction or an intolerance to the medication that land them in the hospital or worse. I saw an interview with a woman who''s baby died because of OTC cold medicine. She gave him the proper dosage listed on the package, but he had an intolerance to one of the ingredients (the decongestant I believe) which caused him to die. He basically died of an overdose because his body couldn''t properly process the drug even though he was given a "correct" amount.

Kind of a scary thing since none of this was known when my children were smaller. Luckily they didn''t have any problems. But I didn''t give them too much OTC medicine when they were really little besides Tylenol/Motrin and, from what I understand, it isn''t the pain relievers that are the problem.

[yg5gon]

It all sounds to be like doctors and the FDA are working together on this somehow. They want us, parents, to always go to the doctors, pay the doctor''s visit so that they can prescribe our kids the same medicine you can get over the counter. C''mon, give me a break. I''m also a resposible parent who always, always give the right dosage of medicine to my son when necessary. It is really unfair that we have to pay for those irresponsible parents that don''t bother in reading the label for instructions.

[alexma50085]

dredre2k:

Why do you have such a problem with cloned meat?? You would never know a cloned animal from a regular animal. I would accutually think it could be healthier for us. We can keep the abnormalities out of the livestock, while keeping numbers high. Why do people have such big issues about this?? Millions of people are starving, cloning could be a way to end world hunger.

[alexma50085]

Last October, CBS News correspondent Wyatt Andrews reported that the cold and cough medicine industry admitted that 92 deaths were connected to combination cold medicines - but claimed 79 of them were due to misuse or overdose.

That number is wrong, it''s 123 children and that is from 1969 to 2006. So that puts it at about 3 deaths a year. More children die in car accident, but we still let them ride in cars.
These FDA expert must not have ever had to deal with a toddler suffering from a cold. Maybe if they had to spend the week with a sick toddler that cry''s and complains and doesn''t sleep, they would realise the grave mistake they have made.
No person would think of suffering through a cold without some kind of relief, why are we making our children suffer?? All because some parents can''t read and adhire to the dosage label?? That to me is a poor excuse to make millions of parents suffer along with their children.

[antoniof123]

This is not the first warning about cold remedies and tots: Drug companies last October quit selling dozens of versions targeted specifically to babies and toddlers, CBS News reports.

What big Pharma doesn''t have our best interest at heart. But that has been the way we were taught. No wait in the 60''s we took control of it but by 2002 big business took control from us.

[nonameabc]

I blame the government and the drug company, any corruption inside, how do we know after so many years!? Second though, if the clone meats are ok, send the meats to those who said are ok and feed them free for 10 yrs. It is all corruption.

[dredre2k]

... and this is the same FDA that''s telling us that Cloned meat is safe to eat... yeah right. Cold medicine has been helping children for years. Where''s the proof?