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Antidepressant
Safety in Children
In
mid October 2004 the US Food and Drug Administration (FDA) announced new
warnings and precautions to strengthen safeguards for children and
adolescents treated with antidepressant medications.
A “black box” warning is to be added to the package inserts and
a Medguide (small information pamphlet) is to be handed out when the
prescription is picked up at the pharmacy.
The caution and added information is to ensure parents are aware of
the possibility of increased suicidal thinking and behavior that may occur
in a small percentage of children and adolescents especially during the
early phase of treatment. Monitoring
and communication between parent, patient, and doctor are encouraged.The
main medications affected are the SRI (Serotonin Reuptake Inhibitor)
antidepressants which include Prozac (generic is fluoxetine), Zoloft,
Paxil (paroxetine), Luvox (fluvoxamine), Celexa, and Lexapro.
The FDA caution does affect all antidepressants though that
seems even more questionable. Please
see my website (leeheymd.com) medicine
charts for information about and the names of the various
antidepressants.
What
led to this action? The FDA
and a team at Columbia University recently reported that in a review of 24
studies using antidepressants (mostly SRI’s) in over 4400 youth
(children and teen) patients the rate of suicidal thoughts or behavior
amongst youth taking placebo (fake pills) was 2 % and that the rate
amongst youth taking antidepressants was 4 %.
There were no completed suicides in any of these 4400
patients. Thus, the actual risk was that 2 of every 100 youth who took
antidepressants had suicidal thoughts or behavior possibly related to the
medicine and that 98 out of every 100 did not.
How
do we make sense of this information? The no deaths in 4400 studied youths
is very important to remember. In
the last 10 years since these medicines have become available for youth
there has been a 25% decrease in
the suicide rate among youth leading to literally thousands of saved lives
and many more improved lives. Many doctors view the FDA action and media
attention as over-reaction based on politics rather than science.
This is why these medicines will remain excellent options. So why might 2% of youth taking these medicines have an
increase in suicide thoughts or actions?
One reason is that suicide risk is higher for some people early in
recovery when they have improved enough that they have the energy to act
on such impulses but have not yet improved enough for the impulses to go
away. A related possibility
is that if the patient has energizing, disinhibiting, or agitating
behavioral side effects their usual behavior or typical personality may
temporarily be altered enough that they may do things they wouldn’t
normally do. (See my Medical
Memo newsletter Summer
1999 issue entitled “What
Are Behavioral Side Effects?”) Although
I have not seen this energizing side effect result in suicidal or violent
behavior I think this is the kernel of truth behind the data and affects
whether and which medicine I choose since some medicines are less likely
to have this energizing effect. Another
possible explanation for an increase in self harm ideas or behavior is
that the diagnosis is in error and therefore the medicine choice is not
optimal. These possibilities
are a main reason why appointments are more frequent in the early stages
of recovery. Medicine is most
appropriate for moderate to severe or complicated cases and when other
treatments have failed. At
times medicine alone is enough but most often combining psychotherapy,
environmental changes, and/or behavioral therapies with medicine is best.
Cymbalta, A New Medication Option
In the fall of 2004 the new SNRI (serotonin and norepinephrine reuptake
inhibitor) Cymbalta (duloxetine) was approved by the FDA and became
available for use in adults for Depression and diabetic neuropathy pain.
It is also expected to prove helpful for anxiety, panic, OCD, and
possibly for other physical pain disorders in all age groups.
Cymbalta combines the serotonin increasing action of SRI’s
(Prozac, Zoloft, Celexa, etc) with
the norepinephrine increasing action of Wellbutrin (buproprion) and
Strattera (atomoxetine). This
dual action makes Cymbalta a broader spectrum potentially more effective
medicine. Some such medicines
with multiple actions help pain and physical symptoms of depression more
than single action options. Cymbalta
is most similar to Effexor (venlafaxine) which is also a dual acting SNRI.
However, Cymbalta’s dual effect begins right away while Effexor
has only the serotonin benefit until the dose is raised high enough for
the norepinephrine effect to kick in. Dual action also means more potential side effects than
single action meds. These
include possible negative side effects on nausea, energy, sleep, sexual
effects, sweating, blood pressure, or weight.
Taking it with or soon after food and starting at a low dose lessen the
chance of nausea. Headaches
may be less common with Cymbalta than with placebo (ie, it may help
prevent headaches). Interactions
with other medicines are relatively few.
Alcohol is best avoided. Like
all medicines it is to be avoided if possible in pregnancy and probably in
breast feeding. Capsules are
available in 20, 30, and 60 mg doses. Dose ranges from 20 to 120 mg a day
taken once or split up twice a day with the most common expected dose
around 60 mg a day. As with
other antidepressant and most anti-anxiety medicines it is best tapered on
and off – not stopped suddenly. Like
other such medicines, although its effect may begin in the first few days,
generally it takes 1 to 3 weeks to kick in and a good month to see what a
given dose will do. Cymbalta,
which some jokingly say sounds like the name of a character from Lion
King, is a favorably anticipated new option whose overall value will
become clearer with time.
Please see my website (leeheymd.com) medicine
charts for more information.