10-10-07
On Friday, October 10’th 2007, experts commissioned by the FDA recommended that the Food and Drug Administration pull approval for all cold and cough medicines for children under 6, a move considered long overdue by many pediatricians and child safety experts. Many drug makers, anticipating the release of the
study, had already made a move to preemptively withdraw all cold medicines aimed at children under two a week earlier.

The Facts & Findings:
1) Cold  medicines  marketed  towards  children  are ineffective,  and include ingredients known to be dangerous. The products have been responsible for numerous child deaths. The ingredients used for the medicines, the same ones found in adult medication for coughs and colds, do not work in kids under 12 and should not be used.

2) In two separate votes, panelists said the medicines shouldn’t be used in  children under  two,  or  in  children  under  six.  Another  vote  to recommend against the use of such medicines for kids ages 6-11 failed, though the panel did agree that there
is no evidence suggesting such medicines work for this age group either.

3) The recommendation applies to all cold and cough medicines with decongestants, expectorants, antihistamines, or antitussives, including many  popular  products  such  as  Dimetapp,  Pediacare,  Robitussin, Triaminic, Little Colds, and versions of Tylenol designed for cold and coughs.  Thirty-nine different drugs are used in pediatric cold and cough products.

4) FDA pediatrician Dr. Dianne Murphy stressed that parents must understand that cold remedies are only designed to suppress symptoms, and don’t make colds go away any faster. Furthermore, she stated that parents shouldn’t try to suppress those symptoms. Coughs are how the body clears the lungs, and low-grade fevers are a normal defense of the body which helps to fight infections.

5) Many of the active ingredients in such medicines are also used in different drugs, so using a cold medicine in combination with something else often leads to accidental overdose.

6) Many of the drugs, including Wyeth’s Dimetapp and Robitussin, Johnson & Johnsons PediaCare, and Novartis AG’s Triaminic products HAVE NEVER BEEN TESTED IN CHILDREN, something that’s been red-flagged by previous FDA panels as long ago as 1972.

7) The FDA review found just 11 studies of children published over the last  half-century  concerning  the  medications,  NONE  of  which established that the medicines are effective.

8) 800 pediatric cough and cold products are sold yearly in the U.S., equaling 3.8 billion doses and generating 500 million dollars.

What the experts said…
“Pediatricians are taught these products don’t work and may not be safe. Yet almost every parent uses them,” says Dr. Joshua Sharfstein, Baltimore’s health commissioner and pediatrician.

Another physician warned that when “medicine isn’t doing what the family wants, instead of giving as directed every six hours they give every four hours or every two hours,” says Dr. Basil Zitelli of the Children’s  Hospital  of  Pittsburgh,  who sees such children in the emergency room. “What they in effect are doing is poisoning their child.”

“This is not a situation in which pediatric data are lacking and we are unable to say one way or the other…In multiple studies they’ve been found not to be effective in this population at all” wrote Dr. Jay Berkelhammer, President of the American Academy of Pediatrics, in a September 2007 letter to the FDA.

Recommendations for parents and caregivers…

1) Use extreme caution in administering cough and cold medicines to your children, and we would suggest not doing it at all, even to kids over six. Throughout the years we’ve seen numerous deaths from accidental overdoses of cough medicine, even among older kids. In one example, a father gave his two girls cold medicine one night, and woke up to find the six and seven-year-olds dead in their bed.

2) Some panelists feared that the prohibition of children’s cold products would lead to caregivers administering adult products for their children. Don’t do that. Both are inappropriate.

3) DO NOT use such medicines as a ‘sleep helper’ with your children.

4) Instead, give your child plenty of fluids and rest. Add a cool-mist humidifier in their bedroom. Use nose suctions to clear clogged noses, or Saline nose drops to loosen thick secretions so those noses drain more easily. Some chest fragrances
with menthol or other fragrances can help, but be sure to check for age restrictions. Finally, you can administer Acetaminophen or Ibuprofin to ease your child’s pain, as recommended by a doctor, but make sure they don’t contain extra active ingredients.

No parents likes to see their child miserable, and when your little one is suffering from a cold, it’s tempting to want to do whatever possible to ease their suffering. But children’s cold and cough medicines will not help. To truly ease your child’s suffering, forego the over-the-counter children’s  cold  medicines  and  help  with
lots  of  TLC.  For  more information, please visit:

www.fda.gov/cder/drug/advisory/cough-cold.htm www.chpa-info.org