This is just one more example how thebig pharmies who think ONLY of the bottom line have been duping parentsin to filling their little kids with chemcial crap that A) Does notwork B) is dangerous for children. And, it has been know for overTHIRTY years. Thank you FDA! Is there any wonder that asthma, allergiesand all kinds of other maladies are plaguing children in the US today?
From www.finance.yahoo.com
Panel: Kids Shouldn't Use Cold Medicines
Saturday October 20, 5:57 am ET
By Andrew Bridges, Associated Press Writer
Panel Suggests That Cold, Cough Medicines Shouldn't Be Taken by Children Less Than 6 Years Old
WASHINGTON(AP) -- The medicines long used by parents to treat their children'scoughs and colds don't work and shouldn't be used in those younger than6, federal health advisers recommended Friday.
Theover-the-counter medicines should be studied further, even afterdecades in which children have received billions of doses a year, theoutside experts told the Food and Drug Administration. The FDA isn'trequired to follow the advice of its panels of outside experts but doesso most of the time.
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"The data that we have nowis they don't seem to work," said Sean Hennessy, a University ofPennsylvania epidemiologist, one of the FDA experts gathered to examinethe medicines sold to treat common cold symptoms. The recommendationapplies to medicines containing one or more of the followingingredients: decongestants, antihistamines and antitussives. It doesn'tapply to expectorants, though many of the medicines also contain thatingredient.
The nonbinding recommendation is likely to lead to ashake up in how the medicines -- which have long escaped much scrutiny-- are labeled, marketed and used. Just how and how quickly wasn'timmediately clear.
"If the agency chose to restrict use inchildren 6 and under, that won't necessarily lead to a ban on theproducts. It might lead to labeling that says 'do not use,'" said Dr.John Jenkins, director of the FDA's office of new drugs.
Suchlabeling changes could take years to put in place, since the FDA wouldhave to undertake a lengthy rule-making process. Jenkins suggested ifthe drug industry took it upon itself to make such changes, the FDAcould use its enforcement discretion to allow it to do so more quicklythan would be done otherwise.
In fact, the Thursday-Fridaymeeting came just a week after the industry pre-emptively moved toeliminate sales of the nonprescription drugs targeted at children under2.
So what are parents to do if they chose to use the medicines,pending further action? Jenkins recommended they follow the directionswhen giving the medicines to their children, and use them only asdirected. He also counseled they pay close attention to whatingredients the medicines contain and to ask a doctor if they have anyquestions.
In two separate votes Friday, the panelists said themedicines shouldn't be used in children younger than 2 or in thoseyounger than 6. A third vote, to recommend against use in children 6 to11, failed.
Earlier, the panelists voted unanimously torecommend the medicines be studied in children to determine whetherthey work. That recommendation also would require the FDA to undertakea rule-making process to reclassify the medicines, since theingredients they include are now generally recognized as safe andeffective, which doesn't require testing. Again, that process couldtake years, even before any studies themselves get under way.
Thepanel's advice dovetails with a petition filed by pediatricians thatargued the over-the-counter medicines shouldn't be given to childrenyounger than 6, an age group they called the most vulnerable topotential ill effects. The American Academy of Pediatrics and othergroups back the petition.
But FDA officials and panelists agreedthere's no evidence they work in older children, either. Still,panelists held off from recommending against use in those 6 and older.And some said they feared such a prohibition wouldn't eliminate use ofthe medicines by parents.
"They will administer adult productsto their children because they work for them or feel they work forthem," said the panel's patient and family representative, Amy Celentoof Nutley, N.J.
The drug industry says the medicines, used 3.8billion times a year in treating cold and cough symptoms in children,do work and are safe.
"We worked very hard to present data tothe panel and in some cases I felt as though they didn't listen andwhen you are in that position, it's tough," Linda Suydam, president ofthe Consumer Healthcare Products Association, the trade group thatrepresents over-the-counter medicines, told reporters. Suydam pledgedthe industry would study the medicines as recommended and try harder toeducate parents to avoid overdoses that in rare cases have been fatal.
Someof the drugs -- which include Wyeth's Dimetapp and Robitussin, Johnson& Johnson's Pediacare and Novartis AG's Triaminic products -- havenever been tested in children, something flagged as long ago as 1972 bya previous FDA panel.
An FDA review found just 11 studies ofchildren published over the last half-century. Those studies did notestablish that the medicines worked in those cases, according to theagency.
For the most part, the results from tests in adults havebeen extrapolated to determine whether the medicines work in children.But even that evidence is "modest at best," said panel chairwoman Dr.Mary Tinetti of Yale University School of Medicine. Indeed, all but oneof the 22 panelists then voted to say that extrapolation isunacceptable.
The panel also recommended drug makers providestandardized droppers with their liquid cough and cold medicines.Experts had told the panel the sometimes hard-to-use dosing devicescontribute to parents unwittingly overdosing their children.
LaterFriday, the panel recommended the dizzying array of medicines thatcombine multiple ingredients remain on the market -- but only pendingthe results of future studies to determine whether they work.
Thepanel also said cold and cough medicines should not be allowed to bear"doctor-recommended" and similar statements. It wasn't immediatelyclear if such a prohibition would be constitutional.
One healthexpert told the panel that children catch five to eight colds eachyear. Those colds don't necessarily require treatment beyond comfortmeasures that don't involve drugs, said Patricia Jackson Allen, of theNational Association of Pediatric Nurse Practitioners.
From www.finance.yahoo.com
Panel: Kids Shouldn't Use Cold Medicines
Saturday October 20, 5:57 am ET
By Andrew Bridges, Associated Press Writer
Panel Suggests That Cold, Cough Medicines Shouldn't Be Taken by Children Less Than 6 Years Old
WASHINGTON(AP) -- The medicines long used by parents to treat their children'scoughs and colds don't work and shouldn't be used in those younger than6, federal health advisers recommended Friday.
Theover-the-counter medicines should be studied further, even afterdecades in which children have received billions of doses a year, theoutside experts told the Food and Drug Administration. The FDA isn'trequired to follow the advice of its panels of outside experts but doesso most of the time.
ADVERTISEMENT
"The data that we have nowis they don't seem to work," said Sean Hennessy, a University ofPennsylvania epidemiologist, one of the FDA experts gathered to examinethe medicines sold to treat common cold symptoms. The recommendationapplies to medicines containing one or more of the followingingredients: decongestants, antihistamines and antitussives. It doesn'tapply to expectorants, though many of the medicines also contain thatingredient.
The nonbinding recommendation is likely to lead to ashake up in how the medicines -- which have long escaped much scrutiny-- are labeled, marketed and used. Just how and how quickly wasn'timmediately clear.
"If the agency chose to restrict use inchildren 6 and under, that won't necessarily lead to a ban on theproducts. It might lead to labeling that says 'do not use,'" said Dr.John Jenkins, director of the FDA's office of new drugs.
Suchlabeling changes could take years to put in place, since the FDA wouldhave to undertake a lengthy rule-making process. Jenkins suggested ifthe drug industry took it upon itself to make such changes, the FDAcould use its enforcement discretion to allow it to do so more quicklythan would be done otherwise.
In fact, the Thursday-Fridaymeeting came just a week after the industry pre-emptively moved toeliminate sales of the nonprescription drugs targeted at children under2.
So what are parents to do if they chose to use the medicines,pending further action? Jenkins recommended they follow the directionswhen giving the medicines to their children, and use them only asdirected. He also counseled they pay close attention to whatingredients the medicines contain and to ask a doctor if they have anyquestions.
In two separate votes Friday, the panelists said themedicines shouldn't be used in children younger than 2 or in thoseyounger than 6. A third vote, to recommend against use in children 6 to11, failed.
Earlier, the panelists voted unanimously torecommend the medicines be studied in children to determine whetherthey work. That recommendation also would require the FDA to undertakea rule-making process to reclassify the medicines, since theingredients they include are now generally recognized as safe andeffective, which doesn't require testing. Again, that process couldtake years, even before any studies themselves get under way.
Thepanel's advice dovetails with a petition filed by pediatricians thatargued the over-the-counter medicines shouldn't be given to childrenyounger than 6, an age group they called the most vulnerable topotential ill effects. The American Academy of Pediatrics and othergroups back the petition.
But FDA officials and panelists agreedthere's no evidence they work in older children, either. Still,panelists held off from recommending against use in those 6 and older.And some said they feared such a prohibition wouldn't eliminate use ofthe medicines by parents.
"They will administer adult productsto their children because they work for them or feel they work forthem," said the panel's patient and family representative, Amy Celentoof Nutley, N.J.
The drug industry says the medicines, used 3.8billion times a year in treating cold and cough symptoms in children,do work and are safe.
"We worked very hard to present data tothe panel and in some cases I felt as though they didn't listen andwhen you are in that position, it's tough," Linda Suydam, president ofthe Consumer Healthcare Products Association, the trade group thatrepresents over-the-counter medicines, told reporters. Suydam pledgedthe industry would study the medicines as recommended and try harder toeducate parents to avoid overdoses that in rare cases have been fatal.
Someof the drugs -- which include Wyeth's Dimetapp and Robitussin, Johnson& Johnson's Pediacare and Novartis AG's Triaminic products -- havenever been tested in children, something flagged as long ago as 1972 bya previous FDA panel.
An FDA review found just 11 studies ofchildren published over the last half-century. Those studies did notestablish that the medicines worked in those cases, according to theagency.
For the most part, the results from tests in adults havebeen extrapolated to determine whether the medicines work in children.But even that evidence is "modest at best," said panel chairwoman Dr.Mary Tinetti of Yale University School of Medicine. Indeed, all but oneof the 22 panelists then voted to say that extrapolation isunacceptable.
The panel also recommended drug makers providestandardized droppers with their liquid cough and cold medicines.Experts had told the panel the sometimes hard-to-use dosing devicescontribute to parents unwittingly overdosing their children.
LaterFriday, the panel recommended the dizzying array of medicines thatcombine multiple ingredients remain on the market -- but only pendingthe results of future studies to determine whether they work.
Thepanel also said cold and cough medicines should not be allowed to bear"doctor-recommended" and similar statements. It wasn't immediatelyclear if such a prohibition would be constitutional.
One healthexpert told the panel that children catch five to eight colds eachyear. Those colds don't necessarily require treatment beyond comfortmeasures that don't involve drugs, said Patricia Jackson Allen, of theNational Association of Pediatric Nurse Practitioners.
