So many people are ingesting antidepressant medications these
days. But if you have a child or teenager currently taking an
antidepressant medication, read further. There is a potential danger that you
should especially be made aware of. A recent increase in suicides amongst
children and teenagers on antidepressant medications has sparked major
concern, so much concern in fact that the FDA (Food and Drug
Administration) has become involved. Brace yourself as we explore the scary
connection between voluntary fatality and antidepressant medications.
Antidepressants to be Wary of
To alleviate any confusion and to be more definitive with the
antidepressants to which I am referring, the following is a list inclusive of
this warning:
Anafranil (clomipramine HCl)
Aventyl (nortriptyline HCl)
Celexa (citalopram HBr)
Cymbalta (duloxetine HCI)
Cymbalta (duloxetine HCl)
Desyrel (trazodone HCl)
Effexor (venlafaxine HCl)
Elavil (amitriptyline HCl)
Lexapro (escitalopram oxalate)
Limbitrol (chlordiazepoxide/amitriptyline)
Ludiomil (Maprotiline HCl)
Luvox (fluvoxamine maleate)
Marplan (isocarboxazid)
Nardil (phenelzine sulfate)
Norpramin (desipramine HCl)
Pamelor (nortriptyline HCl)
Parnate (tranylcypromine sulfate)
Paxil (paroxetine HCl)
Pexeva (paroxetine mesylate)
Prozac (fluoxetine HCl)
Remeron (mirtazapine)
Sarafem (fluoxetine HCl)
Serzone (nefazodone HCl)
Sinequan (doxepin HCl)
Surmontil (trimipramine)
Symbyax (olanzapine/fluoxetine)
Tofranil (imipramine HCl)
Tofranil-PM (impiramine pamoate)
Triavil (Perphenaine/Amitriptyline)
Vivactil (protriptyline HCl)
Wellbutrin (bupropion HCl)
Zyban (bupropion HCl)
Among the antidepressants, only Prozac is approved for use in treating
MDD (major depressive disorder) in pediatric patients. Prozac, Zoloft,
Luvox, and Anafranil are approved for OCD (obsessive compulsive
disorder) in pediatric patients. None of the drugs is approved for other
psychiatric indications in children.
Clinical Trials and their Alarming Results
The risk of suicidality (suicidal thoughts and behavior) for these
drugs was identified in a combined analysis of short-term (up to 4 months)
placebo-controlled trials of nine antidepressant drugs-including the
selective serotonin reuptake inhibitors (SSRIs) and others-in children
and adolescents with MDD, OCD, or other psychiatric disorders.
A cumulative total of 24 trials involving over 4400 patients were
included in the analysis, which depicted a higher risk of suicidality during
the first few months of treatment in those receiving antidepressants.
The average risk of such events on drug was four percent, double the
placebo risk of two percent. Though suicidality was present, no actual
suicides occurred during these trials.
New Product Labels Ordered by FDA
The FDA directed manufacturers of all antidepressant drugs to revise
the labeling for their products to include a boxed warning and extensive
warning statements that alert health care providers to an increased
risk of suicidality in children and adolescents being treated with these
agents, and to include additional information about the results of
pediatric studies.
The FDA also informed these manufacturers that it has
determined that a Patient Medication Guide (MedGuide)-which will be
distributed to patients receiving the drugs to advise them of the risk and
precautions that can be taken-is appropriate for these drug products.
These labeling changes are consistent with the recommendations made to the
Agency at a joint meeting of the Psychopharmacologic Drugs Advisory
Committee and the Pediatric Drugs Advisory Committee on September 13-14,
2004.
In addition to the boxed warning and other information in professional
labeling on antidepressants, MedGuides are being prepared for all of
the antidepressants to provide information about the risk of suicidality
in children and adolescents directly to patients and their families and
caregivers. The pharmacist, with each new prescription or refill of a
medication, should distribute MedGuides.
Based on the conclusive data from the 24 trials conducted, the FDA has
determined that the following points are appropriate for inclusion in
the boxed warning:
1. Antidepressants increase the risk of suicidal thinking and behavior
(suicidality) in children and adolescents with MDD and other
psychiatric disorders.
2. Anyone considering the use of an antidepressant in a child or
adolescent for any clinical use must balance the risk of increased
suicidality with the clinical need.
3. Patients who are started on therapy should be observed closely for
clinical worsening, suicidality, or unusual changes in behavior.
4. Families and caregivers should be advised to closely observe the
patient and to communicate with the prescriber.
5. A statement regarding whether the particular drug is approved for
any pediatric indication(s) and, if so, which one(s).
Potential Warning Signs
Tragically, not all suicides of this nature were prevented.
Fortunately, there are, however, some usually conspicuous warning signs that can
be observed to aid in preventing any future unnecessary deaths if the
child's primary caregivers closely observe the child's behavior on a
daily basis.
1. Clinical Worsening
2. Agitation
3. Irritability
4. Suicidality
5. Unusual Changes in Behavior (especially during the initial course of
the treatment)
It is also recommended that prescriptions for antidepressants be
written for the smallest quantity of tablets consistent with good patient
management, in order to reduce the risk of overdose.
It seems like an oxymoron to me that something that is supposed to
treat depression may actually be amplifying and worsening it to the degree
of someone wanting to create his own demise.
While there is no denying
that many people truly do have a genuine need for such medications, it
has become commonplace to freely hand out pills in our society.
You complain of being unhappy, well here, we have a pill to fix that problem.
I viewed a commercial some time ago for an antidepressant that stated
one indication of being depressed is feeling sad for two or more weeks.
Any traumatic event in life could inflict two weeks (or more) of
sadness; someone could have underwent a divorce or lost a loved one or just
discovered that they have a terminal illness.
But please do not misunderstand, I am not condemning the usage of these medicines; I am only saying to be careful. The bottom line is to be wary and attentive of how your children are responding to the medication, especially during the first few months of taking it to prevent any potential tragedy. You just might save your child's life.