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Old 10-15-2004, 12:04 PM
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Exclamation New Warning Lables to be Placed on Antidepressent Medications

FOR IMMEDIATE RELEASE Media Inquiries: 301-827-6242
P04-97 Consumer Inquiries: 888-INFO-FDA
October 15, 2004


The Food and Drug Administration (FDA) today issued a Public Health Advisory announcing a multi-pronged strategy to warn the public about the increased risk of suicidal thoughts and behavior (“suicidality”) in children and adolescents being treated with antidepressant medications.
The agency is directing manufacturers to add a “black box” warning to the health professional labeling of all antidepressant medications to describe this risk and emphasize the need for close monitoring of patients started on these medications. FDA has also 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, and is in the process of developing one.
“Today’s actions represent FDA’s conclusions about the increased risk of suicidal thoughts and the necessary actions for physicians prescribing these antidepressant drugs and for the children and adolescents taking them. Our conclusions are based on the latest and best science. They reflect what we heard from our advisory committee last month, as well as what many members of the public have told us,” said Dr. Lester M. Crawford, Acting FDA Commissioner.
In letters issued today, FDA directed the manufacturers of all antidepressant medications to add a “black box” warning that describes the increased risk of suicidality in children and adolescents given antidepressant medications and notes what uses the drugs have been approved or not approved for in these patients. FDA's letters to the manufacturers also discuss other labeling changes designed to include additional information about pediatric studies of these drugs. These labeling changes are applicable to the entire category of antidepressant medications because the currently available data are not adequate to exclude any single medication from the increased risk of suicidality.
Prozac is currently the only medication approved to treat depression in children and adolescents. The analyses of the placebo controlled trials in children and adolescents summarized in the revised labeling are based on studies of five selective serotonin reuptake inhibitors (SSRIs) (Celexa, Prozac, Luvox, Paxil and Zoloft) and four “atypical” antidepressants (Wellbutrin, Remeron, Serzone and Effexor XR). In these studies, there was no reported case of a suicide.
A “black box” warning is the most serious warning placed in the labeling of a prescription medication. Advertisements that serve to remind health care professionals of a product’s availability (so-called “reminder ads”) are not allowed for products with “black box” warnings. Until now, only ten drug products approved for children contained a black box warning about their use in children. The new warning language does not prohibit the use of antidepressants in children and adolescents. Rather, it warns of the risk of suicidality and encourages prescribers to balance this risk with clinical need.
FDA recognizes that depression and other psychiatric disorders in pediatric patients can have significant consequences if not appropriately treated. The new warning language recognizes this need but advises close monitoring of patients as a way of managing the risk of suicidality.
The second element of the agency’s strategy is a Patient Medication Guide (MedGuide), FDA-approved user-friendly information for patients. MedGuides are intended to be distributed by the pharmacist with each prescription or refill of a medication. FDA will work with the manufacturers of antidepressant medications to make the MedGuides available as soon as possible.
In addition, FDA intends to work with manufacturers to implement “Unit of Use" packaging for all antidepressants as a means of ensuring that patients receive a MedGuide with every prescription or refill. “Unit of use” packaging is a method of preparing a medication in an original container, sealed and pre-labeled by the manufacturer, and containing sufficient medication for one normal course of therapy.
Today’s actions are consistent with the recommendations made at the September 2004 joint meeting of the FDA’s Psychopharmacologic Drugs Advisory Committee and Pediatric Drugs Advisory Committee.
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Old 10-15-2004, 12:09 PM
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FDA Public Health Advisory

October 15, 2004


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

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 (imipramine pamoate)
Triavil (perphenaine/amitriptyline)
Vivactil (protriptyline HCl)
Wellbutrin (bupropion HCl)
Zoloft (sertraline HCl)
Zyban (bupropion HCl)
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