News that the Food and Drug Administration issued a Public Health Advisory to warn the public about the increased risk of suicidal thoughts and behavior in children and adolescents taking antidepressant medications has sent shock waves through families who have a child with depression.
While the situation is complex involving pharmaceutical companies, federal agencies and researchers, one thing is very clear: families need to be vigilant when it comes to their child’s care. Don’t hesitate to ask questions. Read labels carefully. Observe your child’s behavior closely and document your observations, then discuss your concerns with your child’s doctor.
As we know, medication is a life-saver for many individuals – young and old – with depression. We hope that this latest news will prompt funding for more research on treatment for children! We also hope that medication will continue to be a viable option for treatment of depression.
For some time, the Coalition has recognized the need for families to become more aware of research that is being conducted on children’s mental health. We have contemplated hosting a conference for families where researchers from Johns Hopkins, the University of Maryland and the National Institute of Mental Health come together to inform families about current research studies. One such study on ADHD and Bi-Polar at the U of MD is described in the last article at the end of this newsletter. We believe a research conference for families could potentially provide the opportunity for families to have more input into the research agendas of these major research institutions. Please let us know your thoughts on a research conference next spring.
We are also interested in tracking the results of the FDA’s Advisory. If your child is taking an anti-depressant, let us know what your experience has been. Did your doctor discuss the advisory with you? Has your child’s doctor discontinued or changed your child’s medication? Send your experiences to info@mdcoalition.org. We will compile your experiences and share them in our e-newsletter – and with the officials at the Food and Drug Administration. The full text of the FDA Advisory is reprinted below.
-Jane A. Walker
Executive Director
FDA Public Health Advisory
October 15, 2004
Suicidality in Children and Adolescents Being
Treated With Antidepressant Medication
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/cder/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) |
From the University of Maryland -
Does Your Child Have Symptoms of ADHD and Bipolar Disorder?
Little is known about the effects of medication on ADHD and mood symptoms. The University of Maryland Division of Child Psychiatry and Maryland Psychiatric Research Center are hoping to learn more to guide clinicians in their treatment and better understand the treatment your child may already be using.
- Participants are currently being recruited for one of the first treatment studies to examine the effects of treatment on ADHD symptoms in children and adolescents who have been diagnosed with both ADHD and Bipolar Disorder
- Participants must have both ADHD and Bipolar Disorder (any subtype).
- Participants must be between the ages of 6 and 17 years
- Participants will not be taken off their primary mood medication for the study
- Participants will be closely monitored and we will learn about the effects of medication on a number of areas including behavioral and mood ratings, attention measures, and brain functioning
- Participants will receive reimbursement for their time
- Participants may volunteer for a behavioral study only or for a brain imaging study as well to learn about how medication may alter brain functioning
To learn more about this study contact:
Mark Cochran, M.A., at 410-402-6031 or mcochran@mprc.umaryland.edu.
P.I.: Julie Schweitzer, Ph.D. Division of Child Psychiatry and Maryland Psychiatric Research Center, University of Maryland School of Medicine
Where to Find Out More About Medications
Food and Drug Administration, MedWatch Website: www.fda.gov/medwatch
A Guide to Children's Medications. American Academy of Pediatrics. Web site: http://www.aap.org/family/medications.htm
Facts for Families, a series of fact sheets that include information on medications for children, health insurance, how to seek help, and other topics. American Academy of Child and Adolescent Psychiatry. Web site: http://www.aacap.org/publications/factsfam/index.htm
How to Give Medicine to Children. Food and Drug Administration.
Web site: http://www.fda.gov/fdac/features/196_kid.html
