By
Carolyn Poirot, Fort Worth Star-Telegram
Abby
Goldberg, 8, takes nine medications every day to combat severe
asthma -- and she still has a hard time breathing. Seven of her
drugs are not approved for use in children under 12. One tablet,
her mother must break in half. Another pill, the mother cuts in
two with a gadget from the pharmacist.
``She
is bigger now. When she needed quarters, that was really hard,''
says Wendy Goldberg, Abby's mother. The pill is coated and hard,
like a little stone. It doesn't always divide evenly.
``Do
I give her the big half or the small half? I usually give her
the bigger piece in the morning on the theory that if something
really bad happens, at least we will always be awake,'' the mother
testified at a joint hearing sponsored by the Food and Drug Administration
and the American Academy of Pediatrics.
About
70 percent of the drugs used in children have never been tested
in children, according to the Pediatric Pharmacy Advocacy Group.
Even most of the drugs used in the smallest, premature infants
usually are not approved for children.
But that changed April 1, when the FDA began requiring that new
drugs with potential to benefit children be tested in children
and labeled assafe and effective for use in children.
``We've
been experimenting on children for 20 years now,'' says Dr. Dianne
Murphy, director of pediatrics for the FDA. ``Most drugs used
in children have never been adequately tested in children.
``It's important because we know children are not just small adults.
They are changing. Their systems are changing, their brains are
changing, their guts are changing, their bones are all changing,
and we need to know if we are giving them the right dose -- enough
to be therapeutic but not more than necessary,'' Murphy says.
Despite a lack of scientific evidence to support their safety
and effectiveness in youngsters, drugs that work well in adults
are commonly used in children because doctors believe they offer
the best available treatment. (Once a drug is approved by the
FDA, doctors are able to prescribe it for any age patient, as
best they see fit.) In lieu of testing, pediatricians often base
their decisions on reports published in professional journals
and on word-of-mouth.
Prozac,
for instance, was prescribed 349,000 times to pediatric patients
in a single year -- even though the popular anti-depressant carries
a disclaimer warning that ``safety and effectiveness for those
under 12 years of age are not established.''
``Children
sometimes react differently,'' Murphy points out. ``Sometimes
they tolerate drugs better than adults so there are less adverse
effects, but they may have different adverse effects.''
A
whole generation of children had their teeth damaged and discolored
in the late 1960s and early 1970s because of the popular antibiotic
tetracycline.
Adult
males who tested the drug had no such side effects, and it was
never tested in children or in women. As a result, it was years
before researchers made the connection between the drug and the
discolored teeth.
It was even longer before anyone realized that tetracycline antibiotics
cross the placenta in pregnant women and are stored in the fetus's
bones and teeth, where they combine with calcium. As a result,
bone growth may be slow, the baby's teeth may be permanently yellow,
and the tooth enamel may be soft and abnormally susceptible to
cavities.
In
the 1950s, chloramphenicol, an antibiotic that killed penicillin-resistant
infections, was widely used in adults. Newborn babies with infections
were also given chloramphenicol, but without the benefit of studies
on pediatric dosing. Twenty-three babies died before it was learned
that the immature livers of these infants were unable to clear
the drug from their bodies, allowing toxic doses to build up.
In
contrast, pediatric AIDS specialists say many babies born with
HIV may have died because they were not given drugs developed
to treat HIV in adults. Ten years ago, doctors were hesitant to
prescribe the powerful new drugs for babies or pregnant women.
The
nonprofit Pediatric Pharmacy Advocacy Group was set up to improve
the safe use of medications in children through educational programs
for pediatric pharmacists; monitoring FDA testimony on drugs and
adverse drug reactions; and collecting data that deal with the
safe use of drugs in children.
``We
are trying to get pediatric dosage forms established,'' says Hank
Wedemeyer, the group's executive director. ``Most drugs today
have to be manipulated by pharmacists for use in children. They
may need to smash a 500 milligram tablet, break it up to get the
right amount for a child or dissolve it so a child can take it.
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