FDA Ponders Ban On Cold Meds For Kids

Questions Persist About Effectiveness Of Medication On Children Under 6

(CBS/AP)  A top government health official Thursday rejected pediatricians' calls for an immediate ban on over-the-counter cough and cold medicines for young children, saying it might cause unintended harm.

But Food and Drug Administration officials at a public hearing also said they were uncomfortable with the lack of solid scientific data to support continued use of OTC remedies with youngsters, particularly from ages 2-6.

A ban as sought by leading pediatricians' groups - might only drive parents to give adult medicines to their youngsters, said Dr. John Jenkins, who heads the FDA's Office of New Drugs.

"That is a concern for us," said Jenkins. "We do not want to do something that we think will have a positive impact, only to have an unintended negative. That could be an even worse situation."

With a new cold season coming, pediatricians are urging the government to demand a recall of over-the-counter cough and cold medicines for children younger than 6. The effectiveness of the medicines in children was never proven, critics say, and problems with the drugs sent around 7,000 kids to the emergency room last year, reports CBS News correspondent Nancy Cordes.

"When a treatment is ineffective, its risks - unless zero - always exceed its benefits," Dr. Michael Shannon of Children's Hospital in Boston told the FDA panel.

"We don't see a public health emergency here as far as an inherent risk of the products," said the FDA's Jenkins.

But he agreed with critics who say there's no proof the medicines work in kids. "We don't see that adequate evidence of efficacy has been demonstrated in children to date," said Jenkins. Clinical studies to try to settle the issue could take years to complete, and may not provide clear answers.

"It really is a conundrum for us," said Jenkins.

The FDA warned in January against giving OTC cold medicines to children younger than 2. At that time, officials said they expected to decide by spring on recommendations for youngsters up to 11. Now the agency is seeking more advice from doctors, industry and consumers - and officials are not giving a timetable for a decision.

U.S. families spend at least $286 million a year on such cough and cold remedies for children, according to the Nielsen Co. market research firm. In any given week the medicines are used by an estimated 10 percent of all children, with the biggest exposure among 2- to 5-year-olds, a recent Boston University report found.

But colds usually clear up on their own after a few days. Many doctors say rest and plenty of fluids are what it takes to get over a cold.

The industry says OTC medicines have been used for decades in treating kids' colds and are safe for those older than 2. Nonetheless, manufacturers are planning to carry out new studies involving the most common ingredients in the medications. The companies voluntarily stopped selling cough and cold medicines for babies and toddlers last fall.

Soon after that, FDA advisers concluded that the industry did not go far enough and recommended that the drugs not be used for children younger than 6. An expert panel said children ages 6-12 could keep taking the medications while studies are undertaken to settle scientific questions about safety and effectiveness.

It turns out that when the FDA set standards for cough and cold medicines some 30 years ago, no separate studies were done for kids.

Cough and cold medicines send about thousands of children to hospital emergency rooms each year with symptoms ranging from hives and drowsiness to unsteady walking. Low doses of a medicine are not likely to cause a problem; the main risk comes from unintentional overdoses.

The same ingredients usually are found in different products. For example, giving a child a cough syrup and a decongestant could inadvertently lead to an overdose.

The Consumer Healthcare Products Association, which represents the manufacturers, says preventable errors are the problem, not the safety of the ingredients in the medicines. The industry is starting an educational campaign aimed at parents, doctors and day care providers on the importance of following directions and storing medicines in places where kids cannot get at them.

"The data clearly show a majority of adverse events are direct result of misuse of our products," said Linda Suydam, who heads the industry group.

Baltimore health commissioner Dr. Joshua Sharfstein sought to reassure FDA officials worried about unintended consequences if the government moves to restrict the medications and parents start dispensing adult drugs to their preschoolers. Sharfstein said the state of Maryland saw an immediate benefit after OTC cough and cold remedies for tots were removed from store shelves last fall. Calls to poison control about problems with the medicines involving children younger than 2 dropped by 40 percent, from 99 to 60, in the first six months of this year when compared with 2007. Calls involving children 2 to 6 also dropped, but by much less.

"The feared increases in poisonings simply did not happen," said Sharfstein. "In fact, the opposite occurred."

[smurfcrusher]

Apparently, the lobbyists got to the FDA

[ybotheratall]

I can''t believe that people actually BUY this stuff for kids. Ever take a product with "D" in the name? I get shaky and my heart races. The justification for giving these medicines to toddlers on up is ludicrous. You put a vaporizer/humidifier on in the child''s room, maybe some chest rub, some saline spray and a LOT of TLC. I like the video I saw on another news channel last night. The woman (FOR the child medicine lobby types) said, "We know they work because parents buy them". What an uneducated statement! Not everything we buy works. It''s all about the money. Try taking care of your children the old fashioned way and you''ll see just how much better off they will be.

Side effects mean nothing to Big Pharma, their goal is to drug early and drug often all in the name of profit.

[nenutrition]

When are we going to have control of our health and well being? Between the big Pharms running the show and FDA right next to them, we haven''t had a chance to get and stay healthy. Drugs are not the answer as we all know, healthy habits are. This is a situation that absolutely puts our children at risk...Everyone can ponder outcomes, studies etc. But if just one child has an ill effect from OVC cold remedies then you know others will....Natural approaches are better..Like Antioxdants, including OPC''s, Vit C and a good solid Multi....How many of our children take these daily????

[docpeter1953]

The industry says OTC medicines have been used for decades in treating kids'' colds and are safe for those older than 2.

_________________

Possible link to autism?

[hologram5]

Well, they should be banning certain flu shots and immunizations as well then. They still use the preservative marisol which contains 50 times the EPA standards of mercury in it which will cause birth defects as the heavy metal goes right to the uterus in girls to settle in the lining.

[thevicar1]

They cant ban this stuff! How will I get my kid to shut up and go to sleep?

[kennergirl]

So now they are saying that OTC meds don''t work for kids! What''s the point of having the FDA if they approve products that are dangerous to us peons? Then they reject products that are used throughout Europe. I guess if the money is right then anything will get the go-ahead in this place. Figures why medicines are so high priced. Payoffs can get expensive and they have to recoup the money someway.

[myopinion1]

Well, they should be banning certain flu shots and immunizations as well then. They still use the preservative marisol which contains 50 times the EPA standards of mercury in it which will cause birth defects as the heavy metal goes right to the uterus in girls to settle in the lining.

Posted by hologram5 at 08:22 AM

It''s called THIMERISOL and it was taken OUT OF THE VACCINES YEARS AGO and Autism cases are big time on the rise. The vaccine theory nuts are running out of steam. Massive studies by multiple people have shown not ONE BIT of correlation between Autism and vaccines, yet they drone on about it. I think they want free money. Stop whining and take care of your children.

[ybotheratall]

They cant ban this stuff! How will I get my kid to shut up and go to sleep?

Posted by TheVicar1 at 09:10 AM

Best post of the day. Hitting the nail on the head there. Try taking care of your children with a vaporizer/humidifier, ATTENTION, fluids and a light diet. Stop pumping your children full of things that raise their heart rate and blood pressure. They should never have been allowed ON the market in the first place.

[scotch41-2009]

They cant ban this stuff! How will I get my kid to shut up and go to sleep?


--------------------------------------------------------------------------------

Posted by TheVicar1 at 09:10 AM : Oct 03, 2008
~~~~~~~~~~~~~~~~~~~~~~~~~
Search the web for chloroform, just like Casey Anthony did....

[volleymom3]

I have mixed emotions about this. Being the mom of an asthmatic child, we could not use OTC remedies. My other daughter (now a teenager) could take a minimal does of Benedryl and be fine in a few days. My fear is that we are taking an option away due to parents who have no clue what they are giving their children too much or giving them two different brands of meds and they are actually double dosing. I always called the doctor or pharmacist and asked how much dependent on their weight and age. We would have never made it through without benedryl.

[tipsyinct]

Sounds like another step towards communism/dicatorship and population control to me.
Posted by StopSocialis at 02:33 PM : Oct 03, 2008

wow I never thought I would agree with you on anything, but you are absolutely right. There should be no bans on any drugs. The FDA as it is shouldn''t even exist. There absolutely should be an orginization like the FDA to control quality of food and have INFORMATION about the different drugs, but in no way should the government have the power to outlaw anything you put into your own body, or for that matter your kids.

Let the comments fly about irresponsible parents giving their kids adult or even illegal drugs, not that it doesn''t happen but I think that is just media hype. The majority of parents in this country know how to take care of their own kids responsibly if perhaps in different methods. With an orginization to provide legitimate information about the drugs that are out there parents can make informed decisions on what to administer to their children.

[truth1234567]

I THINK THAT CHILDRENS COLD MEDS SHOULD ONLY BE GIVEN BY A PROFFESIONAL.I DO UNDERSTAND THAT SOME PEOPLE DO NOT HAVE THE TIME TO TAKE THEIR CHILDREN TO THE DOCTOR''S OFFICE. I SPEAK FROM EXPERIENCE BECAUSE I HAVE FIVE CHILDREN OF MY OWN. BUT IT IS FOR THE GOOD AND THE SAFETY OF OUR CHILDREN. THE WORLD IS SO CORRUPTED THESE DAYS THAT SOME PEOPLE MAY GIVE THEIR CHILDREN AND OVER-DOSE OF COUGH MEDICINE ON PURPOSE BECAUSE THEY COULD NO LONGER CARE OR HANDLE THEIR CHILDREN, AND THEN CLAIM THAT IT WAS AN ACCIDENT. WE SEE ON THE NEWS ALMOST ON A DAILY BASIS THAT PARENTS ARE KILLING THEIR CHILDREN AND ALL THIS IS AN ESCAPE ROUTE FOR THOSE WHO WANT TO DO HORRIBLE THINGS TO A CHILD AND GET AWAY WITH IT. AS PARENTS IF WE CAN NOT ACT AND PROTECT OUR CHILDREN , THEN WHO IS? LETS NOT GIVE THESE PEOPLE A WAY TO GET AWAY WITH MURDERING AN INNOCENT CHILD. IT IS BAD ENOUGH WE HAVE THE TEMPORARY INSANITY PLEA LETS NOT GIVE THEM AN ESCAPE ROUTE LETS NOT GIVE THE "ANDREA YATES" OUT THERE ANOTHER WAY TO GET AWAY WITH MURDERING AN INNOCENT CHILD.

[tracydinezza]

I''m sorry but I have a HUGE problem with this issue. I believe that IF a parent or care giver is an educated person who is responsible enough to read a label and speak with the Pharmacist on duty about what should be a proper dose,and/or combinations, then there is no harm! If the Parents and Care givers of the world are CARELESS and too ignorant to read and speak with an expert to be certain then, there in lies your problem. Lack of education and ignorance in our world. Not the medication. I kow that I as a mom read labels and ask questions. I know not to give 2 types of decongestant becasue it will over dose. I am aware of what products work best for my children and IF I have any questions I ask the Pharmacy, call our Doctor''s office and speak with a nurse, or even sometimes I call my insurance company''s hotline(they have and on call nurse to answer questions 24/7) So I ask you all to think about the lack of educational funding in this conutry and the lack of common sense of the adults that are at fault in this issue!

[tracydinezza]

Yes, I am aware of my typos. I am just in a hurry.

[deepperppl]

My daughter got a cold at school at the end of August and also at the end of September. The first cold was simple, a slight cough and a runny nose. So, out came the Triaminic Cold and Cough strips. She felt better in two days, which is great, but then she caught a worse cold 4 weeks later. I''m still sick (I catch everything that she brings home). She also had a spider bite, and they swell tremendously. So out comes the Benadryl clear. Then, she comes down with a fever three days later. Out comes the Motrin; now we''re seeing the doctor. He told me to drop the Benadryl, since the Triaminic has Diphenhydramine (same thing as Benadryl). I showed him the labels - no repetition in the meds, so she has continued to take them all. The Triaminic Cold and Cough strips keep her coughing under control. Without it, she was coughing up a lung and crying from the pain. So what do I do if they take the Triaminic Cold and Cough strips off the shelf? I shouldn''t have to take her to the doctor for the sniffles and a cough. I''m sick of stupid people and meth makers making it hard for me to take care of my family with OTC meds. Can anything be done so that honest people who have sense can treat their own mild illnesses?

[deepperppl]

If vaccines don''t cause Autistic symptoms, then why does my state offer free medical care and therapy for kids with AS? I seriously doubt it''s because they are so generous. My daughter got Thimerosal in a flu shot two years ago, when I dropped my guard because every other shot she got didn''t have it. That very day, she began flapping her arms in the typical AS way. I recognized it for what it was because my son, who just turned 14, has AS. And it is a worse case. He got Thimerosal in every injection. I see a correlation under my roof, and I don''t need some idiot who thinks they know everything because they are listening to an industry that demands every kid get immunizations says they are OK, WHILE they reap the financial windfall that follows. It''s a scam, and they know it. They need to just come clean. Avoid any immunization you can; hospital staff does, so why not us?? http://www.usatoday.com/news/health/2007-09-16-flu-doctors_N.htm

[christina199]

I feel that cold meds are ok if taken with correct dose. I also feel that too many meds at a young age inhibits the body from building up your natural defenses. As a child I was not given many meds and I have been a healthcare worker for about 6 years, never have had a flu shot and have had only mild flu.
I am also the mother of six children and only give meds when I really feel they are needed. Otherwise plenty of rest is what is important. Keep the cough and cold meds in the store, and use moderately.