Infant Cold Medicines Recalled

Drug Makers Voluntarily Withdraw Some Products For Kids Under 2 Amid Health Concerns

(CBS/AP)  Drug makers pulled cold medicines targeted for babies and toddlers off the market Thursday, leaving parents to find alternatives for hacking coughs and runny little noses just as fall sniffles get in full swing.

The move represented a pre-emptive strike by over-the-counter drug manufacturers - a week before government advisers were to debate the medicines' fate. But it doesn't end concern about the safety of these remedies for youngsters.

Thursday's withdrawal includes medicines aimed at children under age 2, after the Food and Drug Administration and other health groups reported deaths linked to the remedies in recent years, primarily from unintentional overdoses.

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FYI: Read the complete list of recalled childrens medicines.

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In a statement, the drug manufacturers essentially blame parents for the overdosing children, citing "rare patterns of misuse leading to overdose," reports CBS News correspondent Wyatt Andrews.

“It's important to point out that these medicines are safe and effective when used as directed, and most parents are using them appropriately,” said Linda Suydam, president of the industry trade group.

The American Academy of Pediatrics disagrees. It said, in general, the drugs shouldn't be used for colds in small children.

“This is not a situation in which pediatric data are lacking and we are unable to say one way or the other,” Dr. Jay Berkelhammer, the academy's president, wrote the FDA last month. In multiple studies, they have “been found not to be effective in this population at all.”

Next week, the FDA will consider the possibility of banning these medicines for all children under 6, reports Andrews. Consumer groups say the industry is giving up the infant market in order to keep the rest of the under-6 market.

The FDA is reviewing the safety of cold medicines at the request of Baltimore health commissioner Dr. Joshua Sharfstein and other city officials who reported 900 Maryland children under the age of 4 overdosed on the products in 2004.

"I'd like to think they saw the evidence that the products are not safe and effective and they're doing the right thing," Sharfstein told CBS News' Barry Bagnato. "But we'd like to see broader action because we think the evidence justifies that, as well."

Baltimore city officials were joined by the American Academy of Pediatrics and prominent pediatricians around the country in their petition, which argued that oral cough and cold medicines don't work in children so young, and pose health risks not just for babies but for preschoolers, too.

Scientists inside and outside the FDA have concluded that cough and cold formulations have never been shown to work in children under six years old, reports Andrews. Worse, overdoses of these cold formulas led to the deaths of 123 children between 1969 and 2006.

“Pediatricians are taught these products don't work and may not be safe. Yet almost every parent uses them,” said Dr. Joshua Sharfstein, Baltimore's health commissioner and a pediatrician, who blames ads that overpromise relief.

The challenge, he says, will be to convince parents to try old-fashioned methods, like suctioning out infants' noses or using salt-water nose drops.

“If you can actually pull a booger out with a suction device, people can feel better,” Sharfstein said.

The Consumer Healthcare Products Association announced Thursday that manufacturers were voluntarily ending sales of over-the-counter oral cough and cold products aimed at infants. The list includes infant drops sold under the leading brand names Dimetapp, Pediacare, Robitussin, Triaminic, Little Colds, and versions of Tylenol that contain cough and cold ingredients.

CVS Caremark Corp. added that it would also end sales of CVS-brand equivalents.

[abigail531]

How much do you want to bet that a lot of mothers will be treating their children with adult cold medicines? I wonder if medication prescribed by a doctor would be any safer for little children?

[smith8805]

I wonder why now all of the suden they have decided to remove this medication. It has been around for years and they havent done any thing about it. Call me crazy but maybe there could be a possible link to autism. Think about it developes or is noticed between birth to three it has dramatically increased and they are researching everthing. It used to be 1 in 10,000 children had it less then 10 years ago know its 1 in 94 boys born has autism. What are the young infants and children being exposed to in the med. and shots that we are giving, and being lied to and told are safe. This is a drug that all parents have a potential to buy. I''''m just wondering why now all of the sudden it is being removed.

[whispyseas]

'' ... a naked girl walked in and said i''ve here a tiny acorn i''ll make shine like the sun, and folk doubted, and the girl scratched her head and said e=mc2, and everyone dropped their jaws and shook their heads and said, you really can make that shine like the sun ... and magic happened ... and once, another girl said, i can sail a straight line to here without falling off the globe for the world is round, and she made folk believe, and folk believed, and magic happened ... then a congress said, give us trillions of dollars of weapons and we swear no one will get mugged or raped or killed, and they made folk believe and folk believed, and magic happened ... ''



'' ... little naked girls know well, if one puts a naked girl on a news desk dancing get well feed world songs rallied around the sick beds, then the world will fill with naked girls on news desks everywhere, which is why little naked girls don''t get on news desks, to give little dressed armed boys a chance ... ''

'' ... the coach entered the locker room screaming and hollering about the *** he caught on his team, and the girls all laughed ''coach coach coach, where have you been'', and a little naked boy walked in and said, ''let''s play ball y''all ... ''

'' ... the silly parrot tripped me, somebody get it ... ''

'' ... 36 sick beds each day, 7 days a week, for 36 dollars a day ... ''

[smith8805]

I wonder why now all of the suddeen they have decided to remove this medication. It has been around for years and they havent done any thing about it. Call me crazy but maybe there could be a possible link to autism. Think about it developes or is noticed between birth to three it has dramatically increased and they are researching everthing. It used to be 1 in 10,000 children had it less then 10 years ago know its 1 in 94 boys born has autism. What are the young infants and children being exposed to in the med. and shots that we are giving, and being lied to and told are safe. This is a drug that all parents have a potential to buy ,I''m just wondering why now all of the sudden it is being removed.

[grammawhamma]

homestar: You are so correct that children that are prone to ear infections need these decongestants. Thus reducing the over use of antibiotics or even the possible need for ear surgery.

[homestar75]

"I have six children and they have all taken one or more of these meds and some of them did help and some did not !So naw are we supposed to let our children suffer with a cold ? what happens if there are deaths caused from giving them nothing??"
Right on alishia I''m totally with you...I have 3...and I totally agree.
Also...the CHILDRENS brands are still out there. It''s only the INFANTS that they have recalled. What''s funny, is they have the same dosing ages on them. That always cracked me. I stopped using the infants after my first...becaues the children''s is cheaper, and it has the EXACT SAME ages and weights on it that are on the INFANTS. It is less concentrated, so it''s harder to give a sick baby who doesn''t want to swallow anything. But, you can use the CHILDRENS brand for infants...just do it by weight. My doctors always encouraged me to only use saline, until they finally realized JUST how bad my sons sinuses are. I swear they just write up an antibiotic prescription when they see me coming now, becaues they know I''ve done EVERYTHING possible to stay out of the office.

[homestar75]

Regarding the infant cold medicine recall: The statement that really annoyed me is when the CBS news story sayed that the children''s cold medicines are no better than a placebo, yet they caused 132? deaths? That statement makes no sense, and ANY parent of a baby who gets cronic ear infections KNOWS that these products work. And I''m sorry but 132 deaths over 35 years isn''t even statisticly significant. You can''t positively attribute the deaths to the cold medicine. Now there will be more deaths, because dumb parents will guess-timate with the children''s decongestants. My son had at leat 8 ear infections his first year of life, he would have had more if it wasn''t for decongestants helping him drain. You can''t drain fluid from ears with saline and a bulb syringe. Natural is great, but my son probably would have had a worse first year, and possibly permanent damage had he not used decongestants. He is 3 now...and when he even catches a viral cold, it''s only with a combination of saline treatments, nebulizer treatments, a humidifier, AND decongestants that he recovers without antibiotics for the inevitable secondary sinus infection. Sometimes that doesn''t even work. My sister went and stocked up when she found out that they were being pulled, because she has a 6 month old prone to ear infections. Luckily my 7 month old hasn''t had one yet!
Every baby is different and has different needs...some need decongestants.
Grrrrrr. Stupid FDA.

[lucy-in-tx]

Just because there are a some idiots who probably choose to overdose their children on cold meds means my little grandsons, who have responsible parents and grandparents, have to suffer through nasty colds with no relief? Good grief! *shakes head... and thinks ANY parent who brings a child into the ER with obvious overdose symptoms should be investigated, but then on second thought... any parent who DID accidently overdose a child would not seek help, but then again... a responsible parent would seek help. But then again... and so it goes.
And now... it is obvious that some folks will go ahead and dose their child - children - with cold meds meant for adults. *shakes head again... and wonders about the ''powers that be'' who make up the rules as we all go along.

[jsdmgray]

Hi Hanna,
concerning the infant medicine recall - has there been an investigation on the droppers? My grandson is 20 months old and I have noticed a difference in the sizes of the droppers given by pharamacies and over the counter meds. The milliliters on one dropper is not the same quantity as on other droppers.
dawn gray

[drinuk]

BC Kelly, Fine suggestion until you understand that Big Pharma has it''s tentacles everywhere, including holding large amounts of stocks in the majority of media companies. Even if CBS programme controllers decided upon moral grounds to resist such advertising, they would quickly be overruled from the board room.

Big Pharma spent 8 billion dollars lobbying Washington this last year, they do what they want to do and not what is good for public health. Such a vast amount of money renders the FDA useless and it is a poor excuse to state that parents are using these medicines to excess. Most of this junk is Snake Oil which the FDA should have pulled years ago, however in their incestuous relationship with Big Pharma the question was never going to arise.

[grammawhamma]

Posted by mommyme39 at 07:03 PM : Oct 11, 2007

If your comment was aimed at me...you misunderstood what I meant, so let me clarify please. I am for leaving the pediatric drugs available to parents...they should not be removed just because some parents overdosed their children. My fear is now that the children''s medication is no longer available...some "stupid" parents might try to give their children medication made for adults to relieve the child''s symptoms.

[incog-nito]

Simple solution: DON''T overdose your children. Measure dosage using the child''s weight, NOT age. A range from 0 to 2 or 2 to 6 years is too imprecise. Be on the safe side and UNDER-dose and giving medicine only if absolutely necessary, and only the right medication your child needs. Avoid combination formulas, buy single ingredient medication. And if a medication doesn''t work, don''t use it again.

[alishia69]

I have six children and they have all taken one or more of these meds and some of them did help and some did not !So naw are we supposed to let our children suffer with a cold ? what happens if there are deaths caused from giving them nothing??

[why_not_nar]

it''s pretty difficult to overdose on vitamens, i am not aware of many documented deaths. perhaps the fda can be too aggessive.

however, you have to counter that with the enourmous amount of pressure that the drug companies place on them to get ''any drug'', including the off label use of many drugs to market.

personally, i would like to see the FDA''s staff increased. in some cases it would be great to get a cancer drug to market quicker, and in others the drug probably should never get to market.

you need an honest broker to make that call. and the FDA is the closest we have to one. Overall i think that their role has been a positive one.

the good news, in the next 10-30 years, the breakthroughs that have been made in science, breakthroughs like mapping of the human genome, tools that allow us to observe the affect of medications like the functional MRI, are leading to a much better understanding of how diseases work. we are, for the first time in history, creating drugs that SHOULD WORK, as appossed to accidently finding ones that do. Pencillin and many other drugs have simply been found by accident.

The result i beleive is that we are going to create 5 to 10 times the medications that are currently available to cure human disease.

That is a great problem to have.

why_not?

[mommyme39]

I dont think there is any reason to call people stupid, and these drugs obviously WERENT made for adults or they wouldnt say children on the box. People want their kids to feel better, everybody with children knows how hard it is to watch them suffer and not be able to do anything about it. If the drugs are bad for them then they SHOULD pull them but I dont think that the parents that have given them to their kids are at fault for trying something that drug companies have put out there saying they WILL releive symptoms.

[why_not_nar]

Katie,
Good story. However one thing that you may have missed. Two weeks ago on 60 Minutes, you reported that Rebecca Riley was given one of these products, or something very much like it shortly before her death. Your two stories may be related.

BTW, in your first looks, being ''understated'', no makeup, no frills comes across as being more genuine. (just do not touch the person you are interviewing. not even a friendly jab in the shoulder. it''s just a habit. and no everyone you interview doesn''t have to repeat, it''s the CBS evening news with Katie Couric, although is was funny the first few times)

Also, your taping of ''how the news happens'' the audio, the graphis, how the stories are edited and put together is fascinating, and something you might consider for a series of real stories.

Understated can be good.

See you later.

[grammawhamma]

You can overdose on vitamins...you can even overdose on water. Need we recall that too? Caregivers of children need education. I hope now that infant drops and cold strips are gone from the shelves that stupid people don''t try to medicate their little ones with medication made for adults!!!!

[gangesdak]

Made in China!

[missingamerica]

Wonder if there is any link between the ever-rising diagnoses of ADHD and ADD and the number of parents over the last several decades who, consciously or not, used "the purple stuff" (and the various other colors) for a sleeping aid for their fretful child?