by Rebecca D. Williams
"Open wide ... here comes the choo-choo."
When it comes to giving children medicine, a little imagination never hurts.
But what's more important is vigilance: giving the medicine at the right time at the
right dose, avoiding interactions between drugs, watching out for tampering, and asking
your child's doctor or the pharmacist about any concerns you may have.
Whether it's a prescription or over-the-counter (OTC) drug, dispensing medicine
properly to children is important. Given incorrectly, drugs may be ineffective or harmful.
Read the Label
"The most important thing for parents is to know what the drug is, how to use it,
and what reactions to look for," says Paula Botstein, M.D., pediatrician and acting
director of the Food and Drug Administration's Office of Drug Evaluation III. She
recommends that a parent should ask the doctor or pharmacist a number of questions before
accepting any prescription:
- What is the drug and what is it for?
- Will there be a problem with other drugs my child is taking?
- How often and for how long does my child need to take it?
- What if my child misses a dose?
- What side effects does it have and how soon will it start working?
It's also a good idea to check the prescription after it has been filled. Does it look
right? Is it the color and size you were expecting? If not, ask the pharmacist to explain.
Check for signs of tampering in any OTC product. The safety seal should be intact
before opening. Also, parents should be extra careful to read the label of
over-the-counter medicines.
"Read the label, and read it thoroughly," says Debra Bowen, M.D., an
internist and director of FDA's medical review staff in the Office of OTC Drugs.
"There are many warnings on there, and they were written for a reason. Don't use the
product until you understand what's on the label."
Make sure the drug is safe for children. This information will be on the label. If the
label doesn't contain a pediatric dose, don't assume it's safe for anyone under 12 years
old. If you still have questions, ask the doctor or pharmacist.
Children are more sensitive than adults to many drugs. Antihistamines and alcohol, for
example, two common ingredients in cold medications, can have adverse effects on young
patients, causing excitability or excessive drowsiness. Some drugs, like aspirin, can
cause serious illness or even death in children with chickenpox or flu symptoms. Both
alcohol and aspirin are present in some children's medications and are listed on the
labels.
Younger and Trickier
The younger the child, the trickier using medicine is. Children under 2 years shouldn't
be given any over-the-counter drug without a doctor's OK. Your pediatrician can tell you
how much of a common drug, like acetaminophen (Tylenol), is safe for babies.
Prescription drugs, also, can work differently in children than adults. Some
barbiturates, for example, which make adults feel sluggish, will make a child hyperactive.
Amphetamines, which stimulate adults, can calm children.
When giving any drug to a child, watch closely for side effects.
"If you're not happy with what's happening with your child, don't assume that
everything's OK," says Botstein. "Always be suspicious. It's better to make the
extra calls to the doctor or nurse practitioner than to have a bad reaction to a
drug."
And before parents dole out OTC drugs, they should consider whether they're truly
necessary, Botstein says.
Americans love to medicateperhaps too much. A study published in the October 1994
issue of the Journal of the American Medical Association found that more than half of all
mothers surveyed had given their 3-year-olds an OTC medication in the previous month.
Not every cold needs medicine. Common viruses run their course in seven to 10 days with
or without medication. While some OTC medications can sometimes make children more
comfortable and help them eat and rest better, others may trigger allergic reactions or
changes for the worse in sleeping, eating and behavior. Antibiotics, available by
prescription, don't work at all on cold viruses.
"There's not a medicine to cure everything or to make every symptom go away,"
says Botstein. "Just because your child is miserable and your heart aches to see her
that way, doesn't mean she needs drugs."
Dosing Dilemmas
The first rule of safety for any medicine is to give the right dose at the right time
interval.
Prescription drugs come with precise instructions from the doctor, and parents should
follow them carefully. OTC drugs also have dosing instruction on their labels. Getting the
dosage right for an OTC drug is just as important as it is for a prescription drug.
Reactions and overdosing can happen with OTC products, especially if parents don't
understand the label or fail to measure the medicine correctly. Similar problems can also
occur when parents give children several different kinds of medicine with duplicate
ingredients.
"People should exercise some caution about taking a bunch of medicines and loading
them onto a kid," Botstein says.
Pediatric liquid medicines can be given with a variety of dosing instruments: plastic
medicine cups, hypodermic syringes without needles, oral syringes, oral droppers, and
cylindrical dosing spoons.
Whether they measure teaspoons, tablespoons, ounces, or milliliters, these devices are
preferable to using regular tableware to give medicines because one type of teaspoon may
be twice the size of another. If a product comes with a particular measuring device, it's
best to use it instead of a device from another product.
It's also important to read measuring instruments carefully. The numbers on the sides
of the dosing instruments are sometimes small and difficult to read. In at least one case,
they were inaccurate. In 1992, FDA received a report of a child who had been given two
tablespoons of acetaminophen rather than two teaspoons because the cup had confusing
measurements printed on it. The incident prompted a nationwide recall of medicines with
dosage cups.
The following are some tips for using common dosing instruments:
- Syringes: Syringes are convenient for infants who can't drink from a cup. A
parent can squirt the medicine in the back of the child's mouth where it's less likely to
spill out. Syringes are also convenient for storing a dose. The parent can measure it out
for a babysitter to use later. Some syringes come with caps to prevent medicine from
leaking out. These caps are usually small and are choking hazards. Parents who provide a
syringe with a cap to a babysitter for later use should caution the sitter to remove the
cap before giving the medicine to the child. The cap should be discarded or placed where
the child can't get at it. There are two kinds of syringes: oral syringes made
specifically for administering medicine by mouth, and hypodermic syringes (for
injections), which can be used for oral medication if the needles are removed. For safety,
parents should remove the needle from a hypodermic syringe. Always remove the
cap before administering the medication into the child's mouth.
- Droppers: These are safe and easy to use with infants and children too young to
drink from a cup. Be sure to measure at eye level and administer quickly, because droppers
tend to drip.
- Cylindrical dosing spoons: These are convenient for children who can drink from a
cup but are likely to spill. The spoon looks like a test tube with a spoon formed at the
top end. Small children can hold the long handle easily, and the small spoon fits easily
in their mouths.
- Dosage cups: These are convenient for children who can drink from a cup without
spilling. Be sure to check the numbers carefully on the side, and measure out liquid
medicine with the cup at eye level on a flat surface.
FDA Proposes New Regulations
FDA is working on changing the labels of over-the-counter medications to make them more
eye-catching, easier to read, and consumer-friendly. One such label appears on the
recently approved OTC version of children's Motrin.
For prescription drugs, FDA took measures in December 1994 to provide more information
to health-care providers about use of those products in children. This rule was final in
January 1995.
The agency now lets prescription drug manufacturers base pediatric labeling on data
extrapolated from adequate and well-controlled adult studies, together with other
information about safety and dosing in children. This is allowed as long as the agency
concludes that the course of the disease and the drug's effects are sufficiently similar
in children and adults.
Presently, most prescription drugs do not contain pediatric doses on their labels. A
1979 regulation required full clinical trials in children as the basis for pediatric
labeling. Doctors who need to prescribe those drugs to children do so based on their own
experience and reports in medical literature. The new regulations will give health-care
providers more information to prescribe medicine for children safely.
In addition, FDA is taking steps to increase the numbers of drugs being tested in
children, and the agency is working closely with the National Institute of Child Health
and Human Development to conduct pediatric studies.
The goal of FDA's changes is to help ensure that whenever a child receives medication,
it is as safe and effective as possible.
| Aspirin and Children Remember those orange-flavored baby aspirin tablets?
They're not usually for kids anymore.
Children and teenagers should never take aspirin, or products containing aspirin or
other salicylates, if they have chickenpox or flu symptoms or are recovering from these or
other viral illnesses. Such aspirin use has been associated with Reye syndrome, a rare but
serious condition that can cause death.
"The incidence of Reye syndrome has dropped dramatically," says Debbie
Lumpkins, an FDA microbiologist in the Office of OTC Drugs, "but that doesn't mean it
can't still happen."
FDA has proposed adding a more descriptive warning label on aspirin and other products
containing salicylates. The label would describe symptoms of Reye syndrome in more detail
than it does now.
To reduce fever safely in children, use acetaminophen or ibuprofen products.
Rebecca D. Williams is a writer in Oak Ridge, Tenn.
|
A REPRINT FROM
FDA CONSUMER MAGAZINE
Printed May 1996
This reprint contains revisions made in May 1996.
This article originally appeared in the January/February 1996 FDA
Consumer.
Publication No. (FDA) 96-3223 |
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Public Health Service Food and Drug Administration
FDA on the internet: http://www.fda.gov/
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