NYT: U.S. Reviewing Safety of Children’s Cough Drugs

[Doondoo]

Federal drug regulators have started a broad review of the safety of popular cough and cold remedies meant for children, a top official said Thursday. The official, Dr. Charles J. Ganley, director of the office of nonprescription drug products at the Food and Drug Administration, said in an interview that the agency was “revisiting the risks and benefits of the use of these drugs in children” and that “we’re particularly concerned about the use of these drugs in children less than 2 years of age.”

In higher than normal doses, cold medicines can affect the heart’s electrical system, leading to arrhythmias. Some medicines affect the blood vessels and, in high doses, have been associated with hypertension and stroke. In rare cases, children have been injured even when given recommended doses.

In a recent study of hospital emergency room records from 2004 and 2005, the Centers for Disease Control and Prevention found that at least 1,519 children under age 2 had suffered serious health problems after being treated with common cough and cold medicines. Three of the children died, the disease control agency found.

.......

Dr. Ganley of the F.D.A. said most over-the-counter cold and cough medicines had not been adequately tested in children. The doses recommended on many of the products’ labels were no better than educated guesses, he said.

“We have no data on these agents of what’s a safe and effective dose in children,” Dr. Ganley said.



http://www.nytimes.com/2007/03/02/health/02cough.html?ref=health

[Benhurst]

1. “We have no data on these agents of what’s a safe and effective dose in children,” Dr. Ganley said.

Dear god, if they aren't protecting the children, what in the hell are they doing to justify their existence?

[Kagemusha]

2. So the government should use children as guinea pigs for testing?

See? Doesn't sound so good now. In some ways you're gonna be snakebitten no matter which option's taken.

[Benhurst]

3. The drugs should never have been released without adequate

testing as to their safety for use by children. BushAmerica: anything for a fast buck.

And don't think the "miracle of the marketplace" isn't testing them on children right now. If enough children get killed or injured by the inadequately-tested product to cause litigation and interfere with corporate profits, the product will be withdrawn -- but the lives of the innocent victims can not be restored.

[Kagemusha]

5. I'm just wondering what testing means other than using them on kids.

I'm wondering how any other testing could be considered adequate.

[Benhurst]

7. Probably not. But proper testing would be done under controled

conditions and CLOSELY monitored, hopefully catching bad reactions before they run full course.

Putting a product on the market which has not been properly vetted is highly irresponsible. But in a society where profits are the bottom line for everything, such behavior should not come as a surprise.

[Kagemusha]

8. I see what you're saying, but the "OMG you're testing on kids!" thing will arise

That's why they've been extrapolating from older children to younger children and rolling the dice a bit. I tend to agree with you on the science of it all, though.

[AnneD]

4. The fact that they

extrapolate the dat is bad enough...but get a load of this- until the flu epidemic that hit Texas so hard 2 years ago (where there were quite a few children die), the CDC kept no stats on the number of children that died from flu. The Docs here pitched such a fit that they started recording those deaths. And because of THAT data, they are starting to recommend flu shot for kids. Thanks for thanks for protcting us guys.:eyes::sarcasm:

Edited to add that during the first few years of King Georges reign-we had such a nation wide shortage of DT and DPT vaccines-it was rationed. All the while they were jumping on our asses (med folks) to take the damn small pox vaccine because of 'TERRA,TERRA, TERRA'.

[DBoon]

6. the terrorists are in the white house

more have likely died from their social experiments than from 9/11

[noonwitch]

9. Children's Benadryl can be a miracle drug for family plane travel, though

Vitamin B, they call it. It makes the kids drowsy, just like adult Benadryl makes adults drowsy.

[AnneD]

10. Just a word of caution...

some drugs-like benadryl-can have a synergistic(opposite)effect. Instead of being drowsy-the kid can be wired. Try it or any med for the first time at home BEFORE giving it to the child on a plane. In addition to a synergistic response-they can have an allergic reaction.

[foo_bar]

11. I think you mean "paradoxical" not "synergistic"

(e.g., http://www.chestjournal.org/cgi/content/abstract/111/6/1766)

[AnneD]

12. Opps

:blush: my bad...I meant paradoxical...If you take it with tea it causes a synergistic effect.....too much info floating in the brain.