Babies shouldn't take cough and cold medicine, the Food and Drug
Administration said Thursday.
The over-the counter drugs aren't safe for children under 2, and
there's no evidence they work, the agency said.
Drug companies voluntarily pulled 14 medicines including infant
varieties of Pediacare, Dimetapp and Tylenol Plus Cold off store
shelves in October when an FDA advisory group recommended that they
not be used.
More changes could be ahead for the lunch box set. The FDA still
is reviewing whether the medicines should be used for children ages
2 to 11. The advisory group already has recommended they not be
used for children younger than 6.
Around Tampa Bay, pediatricians said they've already gotten
several questions about the FDA's decision. Here are some of their
answers.
Do you agree with the FDA action?
It has been a long time coming, some doctors said. The FDA's
action came after pressure from pediatricians, who said the drugs
weren't adequately tested in children.
Thursday, some local pediatricians were adamant that parents
should not give these products to babies.
"I do think parents feel frustrated, but if it's not proven to
work, and it has the potential to harm, we shouldn't be doing it
just to do something," said Dr. Marcy Baker, a Tampa pediatrician.
"There really is no evidence to use any of these cough and cold
products in small children," said Vincent Speranza, clinical
pharmacist at University Community Hospital.
Cold and cough medicines don't help cure a cold; they only
lessen symptoms. But studies say they don't even help with
congestion and other symptoms in children under 2.
But for years I've used these medicines when my children are
sick, and they've never had a problem. How can the medicines be
dangerous?
Serious problems are rare, but since 1969, 123 deaths have been
reported as linked to decongestants and antihistamines.
The FDA also is concerned about overdoses. Many cough and cold
medicines have different names, but the same ingredients. That
means a parent might overdose a child by giving two different
medicines.
"You can package them any way you want, and put whatever animal
you want on the box," said Dr. Steve Karges, a St. Petersburg
pediatrician. "It's the same stuff."
Overdoses from cold medicines are one of the most common calls
to the Florida Poison Information Center-Tampa, said Speranza, the
former managing director there.
But what can I do to help my child's cold?
Pediatricians recommend old-fashioned remedies: lots of fluids,
saline nose drops, humidifiers, bringing the baby into a steamy
bathroom.
What if my child has a fever?
You can still use infants' Tylenol or infants' Motrin.
These medicines really helped when I've given them to my
children. How could I be wrong?
Don't be so sure, doctors say. "In some kids, parents will
swear it's helping, but studies are kind of 50-50," said Dr. M.
Michael Eisenfeld, clinical practice director of the general
pediatrics clinic at All Children's Hospital. "In infants, we do
know there's a higher chance of fussiness and upset tummies."
This may be a time when there's a placebo effect on parents,
Baker said. "You might think this is making your child's nose run
less just because you've given it to them," she said.
Couldn't medicine to relieve congestion help keep my baby from
getting an ear or sinus infection?
No. "There's no evidence that giving cold medicine changes the
risk," Baker said.
Can I give cold medicines for older children to my infant?
No, doctors say. Parents who do that are more likely to give too
much medicine. "I'm a little afraid they'll do that," Eisenfeld
said.
Are there any herbal remedies or supplements they can take?
No, these pediatricians say. Those products could be more
dangerous because they're designed for adults. And since they're
not regulated, their ingredients might not be uniform.
If the FDA is looking at cold medicines for older children,
should I be using them?
If you do, be cautious, doctors say. Use only one medicine,
follow the dosing instructions carefully and then watch your child.
"Step back, and say, 'Is this really doing anything?'?" Baker
said.
For children under 6, doctors are especially cautious.
"You don't need to give them medicine," Eisenfeld said. "They
won't make the cold go away."
I'm afraid I gave my child too much cold medicine. What should I
do?
Call your pediatrician or the poison center toll-free at
1-800-222-1222.
c.2008 St. Petersburg Times