Doctors Press FDA On Cold Meds For Kids

Say Cold Medicines For Infants Pulled From Shelves Shouldn't Be Given To Kids Under 6

(CBS/AP)  Cold and cough medicines recently pulled from sale for infants and toddlers shouldn't be given to children as old as 5, either, pediatricians told government health advisers Thursday.

The expert advisers to the Food and Drug Administration began a two-day meeting to consider a petition from the pediatricians that seeks a government statement saying the over-the-counter medicines shouldn't be used in children under 6 because they don't help them and aren't safe.

The FDA has yet to act on the petition, pending a recommendation expected late Friday from the joint panel of outside experts in pediatrics and nonprescription drugs, said the agency's Dr. Joel Schiffenbauer.

The meeting opens a week after drug makers pulled from sale oral cough and cold medicines for children under 2.

CBS News correspondent Wyatt Andrews reports that the cold and cough medicine industry admits that 92 deaths are connected to combination cold medicines - but claims 79 of them were due to misuse or overdose.

Drug manufacturers continue to maintain that administered correctly, the medicines are safe and effective for sick children over two years of age.

However the petitioners, including Baltimore city health officials, argue that the medicines not only don't work in children up to age 6 but that they can be dangerous as well.

"Are there safe and effective therapies for the common cold?" asked panelist Dr. Ruth Parker, an Emory University School of Medicine professor.

"Love. Liquids. That's what I recommend," said petitioner Dr. Joshua Sharfstein, Baltimore's health commissioner and a pediatrician.

While the medicines have been marketed for use in children for decades - ad spending now is roughly $50 million a year - it has long been acknowledged there is negligible or no data from studies in the very young to show they are safe and work. Worse, some studies suggest the medicines are no better than dummy pills in treating cold and cough symptoms in young children, the petitioners said.

"When a treatment is ineffective, its risks, if not zero, always will exceed its benefits," said Dr. Michael Shannon, a Children's Hospital Boston pediatrician and Harvard Medical School professor who was another of the petitioners.

The drugs - they include some Dimetapp, Pediacare, Robitussin and Triaminic products - have never been tested in children, which a previous FDA panel noted as long ago as 1972. Drug makers instead have used extrapolated data from studies in adults to come up with dosing recommendations based on a child's age or size.

While the focus of the petition and the FDA is on children under 6, the joint panel of experts will be asked if there's evidence that these drugs work in children up to age 12.

The medicines are widely used, with an estimated 95 million packages sold for infant and toddler use each year.

"If these medicines are allegedly not effective or materially unsafe, how is the purchase of millions, hundreds of millions, of doses by parents explained?" asked Dr. George Goldstein, the panel's nonvoting industry representative.

Dr. Dan Levy, president of the Maryland chapter of the American Academy of Pediatrics, said parents buy the medicines for their children because they want quick results. Earlier, Levy also said parents buy the medications for emotional reasons, out of fear, vulnerability and caring.

The recently pulled medicines had recommended parents "ask a doctor" before giving them to children under 2.

"We all have a lot of friends who call up their pediatricians and the pediatricians tell them to take the drugs," said panelist Ralph D'Agostino, a Boston University public health and statistics expert.

Other doctors aren't so quick to give parents the green light. Andrews asked Baltimore pediatrician Dr. Daniel Levy for his perspective.

"How do I advise parents to dose these medications?" Levy responded. "I ask them to unscrew the top of the bottle and in one easy motion, invert it over the toilet."

[rhead5]

Quoting:
"How do I advise parents to dose these medications?" Levy responded. I ask them to unscrew the top of the bottle and in one easy motion, invert it over the toilet."

With this action, parents, as advised by the above medical doctor, may be dosing the whole community by adding the medication to the water supply. For those living in areas with septic fields %u2013 note that adding extraneous materials can damage the system. And who knows what other consequences to the environment may occur? This is not good advice - better to add to the wastebasket %u2013 at least, the medicine will be somewhat contained.

Rebecca A Head, PhD, DABT
Health Officer/Director
Monroe County (MI) Health Department

[brianbwb-2009]

but claims 79 of them were due to misuse or overdose.

So maybe the "tablespoon measurement system" is far from accurate control of dosage, either that or maybe the parents are following it up with a shot of Jack D?

to rhead5, even if it is administered according to proper usage standards, does it not eventually end up in the toilet anyway?

[brianbwb-2009]

but claims 79 of them were due to misuse or overdose.

So maybe the "tablespoon measurement system" is far from accurate control of dosage, either that or maybe the parents are following it up with a shot of Jack D?

to rhead5, even if it is administered according to proper usage standards, does it not eventually end up in the toilet anyway?

[brianbwb-2009]

Take a one pint Kerr canning jar, squeeze in the juice of four lemons, afterward slice what is left and add to the juice. Next fill to 3 quarters full with natural honey, top it off with Jim Beam bourbon. Stir well, cover and shake well, and then seal the mixture by heating the jar in warm water for 5 minutes, then seal.

Voila, the traditional cough syrup that does work, the honey sooths the throat, the lemon gives a bit of vitamin C, and the bourbon relaxes the chest muscles.

To be administered one tablespoon every four hours.

One jar of this will last for months, if kept sealed and refrigerated.

[grammawhamma]

rhead5: Oh get real!! They pay you money to be a Health Officer/Director? Each bottle contains 4 ounces. Yup...that will contaminate a whole community. This is not some "toxic" substance we are talking about, it is a cold medication that is deamed safe to be taken orally by people ages 6 years and older! Geeez.

[rhead5]

I will not continue with further messages after this one (below) but did want to address the comments of those folks who provided initial responses and thank them for their responses.

To respond to GrammaWhamma%u2019s comments%u201D %u201CEach bottle contains 4 ounces. Yup...that will contaminate a whole community. This is not some "toxic" substance we are talking about, it is a cold medication that is deemed safe to be taken orally by people ages 6 years and older! %u201C As we say in toxicology %u2013 the dose makes the poison and 4 oz is not much but if that is multiplied times all the parents, grandparents and other caretakers who may take the advice to discard into our waterways (i.e., down toilets) - that can be significant. Is the compound toxic %u2013 according to the recent news and research %u2013 it is toxic and that is why the use of the medicine is being restricted.

As to brianbwb''s comment: "even if it is administered according to proper usage standards, does it not eventually end up in the toilet anyway?" You are, of course, right - though how the syrup is metabolized and into what compounds is not known to me. However, the issue was how to dispose of unwanted/unused materials and putting that into the trash would be the better way.

[grammawhamma]

rhead5: I am going to diagnose you as suffering from Algoreaphobia.

What do you think the recyling center is going to do with the medication when they recycle the plastic or glass jars it comes in?