- A total of 24 trials involving over 4400 patients were
included. The analysis showed a greater risk of suicidality during the
first few months of treatment in those receiving antidepressants. The average
risk of such events on drug was 4%, TWICE the placebo risk of 2%.
-
- Pediatric patients being treated with antidepressants
for any indication should be closely observed for clinical worsening [increased
depression], as well as agitation, irritability, suicidality, and unusual
changes in behavior, especially during the initial few months of a course
of drug therapy, OR AT TIMES OF DOSE CHANGES, EITHER INCREASES OR DECREASES.
[THIS MEANS IN WITHDRAWAL OF THE MEDICATION].
- http://www.fda.gov/cder/drug/antidepressants/SSRIPHA200410.htm
-
- FDA Public Health Advisory October 15, 2004
-
- Suicidality in Children and Adolescents Being Treated
With Antidepressant Medications
-
- Today the Food and Drug Administration (FDA) directed
manufacturers of all antidepressant drugs to revise the labeling for their
products to include a boxed warning and expanded warning statements that
alert health care providers to an increased risk of suicidality (suicidal
thinking and behavior) in children and adolescents being treated with these
agents, and to include additional information about the results of pediatric
studies. FDA also informed these manufacturers that it has determined that
a Patient Medication Guide (MedGuide), which will be given 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.
-
- The drugs that are the focus of this new labeling language
are all drugs included in the general class of antidepressants; they are
listed at the end of this Advisory.
-
- The risk of suicidality 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
major depressive disorder (MDD), obsessive compulsive disorder (OCD), or
other psychiatric disorders. A total of 24 trials involving over 4400 patients
were included. The analysis showed a greater risk of suicidality during
the first few months of treatment in those receiving antidepressants. The
average risk of such events on drug was 4%, twice the placebo risk of 2%.
No suicides occurred in these trials. Based on these data, FDA has determined
that the following points are appropriate for inclusion in the boxed warning:
-
- - Antidepressants increase the risk of suicidal thinking
and behavior (suicidality) in children and adolescents with MDD and other
psychiatric disorders.
-
- -= 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.
-
- -- Patients who are started on therapy should be observed
closely for clinical worsening, suicidality, or unusual changes in behavior.
-
- -- Families and caregivers should be advised to closely
observe the patient and to communicate with the prescriber.
-
- -- A statement regarding whether the particular drug
is approved for any pediatric indication(s) and, if so, which one(s). Among
the antidepressants, only Prozac is approved for use in treating MDD in
pediatric patients.
-
- -- Prozac, Zoloft, Luvox, and Anafranil are approved
for OCD in pediatric patients. None of the drugs is approved for other
psychiatric indications in children.
-
- -- Pediatric patients being treated with antidepressants
for any indication should be closely observed for clinical worsening, as
well as agitation, irritability, suicidality, and unusual changes in behavior,
especially during the initial few months of a course of drug therapy, or
at times of dose changes, either increases or decreases. This monitoring
should include daily observation by families and caregivers and frequent
contact with the physician. 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.
-
- 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. MedGuides are intended to be distributed by the
pharmacist with each prescription or refill of a medication.
-
- FDA plans to work closely with the manufacturers of all
approved antidepressant products that are the subject of today"s letters
to optimize the safe use of these drugs and implement the proposed labeling
changes and other safety communications in a timely manner. The labeling
changes at issue will be posted on FDA's website
-
- http://www.fda.gov/c der/drug/antidepressants/default.htm.
-
-
- Anafranil (clomipramine HCl)
- Aventyl (nortriptyline HCl)
- Celexa (citalopram HBr)
- 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)
- Zoloft (sertraline HCl)
- Zyban (bupropion HCl)
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