WASHINGTON, DC (October 18, 2004) – The Food & Drug Administration (FDA) last week directed manufacturers of all antidepressant drugs to revise product labeling to include warning statements that alert health care providers to an increased risk of suicidal thinking and behavior (suicidality) in children and adolescents treated with the products.
In addition to boxed warnings and expanded warning statements, the FDA also will require inclusion of information about pediatric study results.
The FDA informed manufacturers of antidepressants that a Patient Medication Guide (MedGuide) advising of the risks and precautions should be given to patients receiving the drugs. The MedGuides are intended to be distributed by the pharmacist with each prescription or refill of a medication.
The labeling changes were consistent with the recommendations made to the FDA at a joint meeting of the Psychopharmacologic Drugs Advisory Committee and the Pediatric Drugs Advisory Committee on September 13-14, 2004. (Pharmaceutical Processing e-Newsletter, September 20, 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 story.
The FDA determined that the following points are appropriate for inclusion in the boxed warning:
· Antidepressants increase the risk of suicidality in children and adolescents with major depressive disorder (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 obsessive compulsive disorder in pediatric patients. None of the drugs is approved for other psychiatric indications in children, the agency said.
The FDA said it plans to work closely with the manufacturers of approved antidepressant products 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. The affected antidepressant drugs include:
Anafranil (clomipramine HCl)
Aventyl (nortriptyline HCl)
Celexa (citalopram HBr)
Cymbalta (duloxetine HCl)
Desyrel (trazodone HCl)
Effexor (venlafaxine HCl)
Elavil (amitriptyline HCl)
Lexapro (escitalopram oxalate)
Ludiomil (Maprotiline HCl)
Luvox (fluvoxamine maleate)
Nardil (phenelzine sulfate)
Norpramin (desipramine HCl)
Pamelor (nortriptyline HCl)
Parnate (tranylcypromine sulfate)
Paxil (paroxetine HCl)
Pexeva (paroxetine mesylate)
Prozac (fluoxetine HCl)
Sarafem (fluoxetine HCl)
Serzone (nefazodone HCl)
Sinequan (doxepin HCl)
Tofranil (imipramine HCl)
Tofranil-PM (imipramine pamoate)
Vivactil (protriptyline HCl)
Wellbutrin (bupropion HCl)
Zoloft (sertraline HCl)
Zyban (bupropion HCl)