Antidepressant Warning

“It was kinda scary,” she says. “I kinda
wanted to go in a corner and hide and not be around people.”

Her doctor prescribed the antidepressant Paxil to help ease
that anxiety. Now, the U.S. Food and Drug Administration (FDA)
warns that Paxil may be unsafe for children under 18.

“When I heard the news that there was a problem with
Paxil, I was horrified,” says Mrs. Radcliff, Elora’s
mother. “And the first thing I wanted to do is stop
giving Elora the medication.”

The FDA cites clinical trials in which kids taking Paxil
were nearly three times more likely to think about or attempt
suicide than kids not taking the drug.

“Any antidepressant can slightly increase the risk
of suicide in those people who are severely depressed,”
explains Dr. Dirk Huttenbach, a board-certified psychiatrist.
“The reason for that is because a lot of people are
so depressed and so immobilized that even though they are
thinking of killing themselves they don’t have the energy
to kill themselves.”

But antidepressants may give patients a boost of energy and
motivation, Dr. Huttenbach says. That’s why children
should be watched closely, especially in the early stages
of treatment.

Elora says the news about Paxil scared her, too.

“I wanted to stop taking it after I heard kids were
suicidal on it, but I thought it might be a little bit more
dangerous to come off of it,” she says.

In fact, it is. Doctors warn that abruptly stopping a course
of treatment with Paxil can lead to dizziness, anxiety, nausea
and sleep problems. The FDA warning is still controversial,
and many doctors say Paxil works.

“It’s been shown time and time again that the
combination of psychotherapeutic and medication efforts is
the most successful in bringing these very severe kids around.
If you don’t do anything, you’re really gonna
raise the risk of suicide,” Dr. Huttenbach says.

Elora says she hasn’t thought of suicide and claims
Paxil has changed her life for the better.

“It helped me a lot. It helped me not be afraid. I’m
not as nervous anymore, and, you know, I’m just happier
all together,” she says.

The British Medicines
and Healthcare products Regulatory Agency (MHRA) has issued
a recommendation that physicians stop prescribing Paxil, sold
as Seroxat in Britain, to treat depression in those under
18. The officials are basing their decision on a study of
1,000 pediatric patients taking GlaxoSmithKline’s Paxil
for depression, which showed that suicidal thoughts and attempts
were twice as high among children taking Paxil than those
taking a placebo.

The use of antidepressants among children and teens is on
the rise, even though few pediatric trials have produced evidence
of the drugs’ safety and effectiveness in children. A University
of Maryland study of children aged 2 to 19, published in the
journal Pediatrics, revealed
these shocking findings about antidepressant prescriptions:

• From 1988 to 1994, prescriptions for anti-depressants
  increased three- to fivefold.
• Prescriptions for all three types of medications –
  selective serotonin reuptake inhibitors (SSRIs), tricyclic
  antidepressants and “other antidepressants” –
  rose, but the rise was greatest for SSRIs, which increased
  19-fold.
• Depending on the state, prescriptions increased four to
  11 times for tricyclic antidepressants and two to three
  times for other anti-depressants.
• In 1994, 13 to 19 out of every 1,000 children were prescribed
  an antidepressant.
• Prescriptions were most common among boys aged 10 to 14
  and girls aged 15 to 19.

If so many children are taking antidepressants, why have
there not been more trials to test their safety and effectiveness?
According to the American College of Neuropsychopharmacology,
until 1997 doctors assumed children’s bodies responded to
drugs as if they were tiny adults, and they would simply cut
the dosage in half for young patients. But when activists
began demanding more tests for drugs on children, a federal
law was enacted in 1997 giving drug companies profitable extensions
of their exclusive marketing rights for medicines in exchange
for studying those medicines in children. Since this testing
process is relatively new, currently no antidepressant medications
are approved for use in children.

The American Academy of Family Physicians
says that the prevalence of major depressive disorder among
U.S. children is approximately 1% of preschoolers, 2% of school-aged
children and 5-8% of adolescents. Treatment for these depressed
children is critical because they experience low energy, poor
concentration and sleeping problems, lose interest in activities
and may eventually become so distressed that they try to kill
themselves.

If you observe any mental, behavioral or emotional symptoms
of depression in your child, it is imperative that you contact
your child’s doctor. The National Institute of Mental Health
says that depressive disorders in children are diagnosed similarly
to adults. A skilled professional will observe the signs and
symptoms and consider them in context of the child’s developmental
level, social and physical environment and reports from parents,
teachers or other caregivers.

Once a child is diagnosed with a mental disorder, treatment
options mainly depend on the severity of the symptoms. Psychosocial
interventions are not always effective, and many times physicians
will prescribe anti-depressants. Like any other drug, psychotropic
medication can cause side effects. If your physician prescribes
an anti-depressant for your child, the Texas Department of
Mental Health and Mental Retardation suggests watching for
these warning signs of side effects:

• Upset stomach
• Headache
• Difficulty sleeping
• Irritability or restlessness
• Dry mouth
• Constipation
• Weight gain

Some side effects are very mild and tend to disappear as
your child continues to take the medication or if the doctor
changes the dose. But some may continue despite changing the
dose, and this usually requires that the medication be stopped.
Above all else, keep constant contact with your doctor. Ask
many questions, and learn everything you can about the medications
prescribed for your child. The more information you know,
the better able you are to care for your child.

American
Academy of Family Physicians
American College
of Neuropsychopharmacology
Medicines
and Healthcare products Regulatory Agency
National
Institute of Mental Health
Pediatrics

Texas Department of
Mental Health and Mental Retardation