Suicidality in children and adolescents being treated with antidepressant medications

In 2004, the 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 healthcare 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.36 The FDA also informed manufacturers that it had determined that a Patient Medication Guide (MedGuide) to 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 in September 2004.36 The drugs that are the focus of this new labeling language are all those included in the general class of antidepressants and are listed on the FDA website.

The suicidality risk associated with these agents was identified in a combined analysis of short-term (up to 4 months) placebo-controlled trials of nine antidepressant drugs, including the SSRIs among others, in children and adolescents with MDD, obsessive compulsive disorder (OCD), or other psychiatric disorders. A total of 24 trials involving over 4400 patients was included.32 The analysis showed a greater risk of suicidality during the first few months of treatment in those receiving antidepressants. The average risk of such an event on drug was 4% — twice the risk on placebo (2%). No suicides occurred in these trials. Based on these data, the 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 fluoxetine is approved for use in treating MDD in pediatric patients. 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 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 2004, an American Medical Association (AMA) report noted that black box warnings on antidepressants should not be interpreted in such a way that would decrease their use in children and adolescents who would benefit from the drugs.32 In January 2005, the FDA added black box warnings to the labels of antidepressants concerning the risk of suicidal thinking and behavior in children and adults. In addition to the boxed warning, FDA and European MedGuides on the risk of suicidality in children and adolescents are being prepared for all antidepressants to provide information directly to patients, their families, and caregivers.

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